Cardiovascular Inflammation Reduction Trial
CIRT
A Randomized, Double-blind, Placebo-controlled, Event-driven Trial of Weekly Low-dose Methotrexate (LDM) in the Prevention of Cardiovascular Events Among Stable Coronary Artery Disease Patients With Type 2 Diabetes or Metabolic Syndrome
3 other identifiers
interventional
4,786
3 countries
470
Brief Summary
The Cardiovascular Inflammation Reduction Trial (CIRT) is a randomized clinical trial investigating whether taking low-dose methotrexate reduces heart attacks, strokes, or death in people with type 2 diabetes or metabolic syndrome that have had a heart attack or multiple coronary blockages. This trial is funded by the National Heart, Lung, and Blood Institute (NHLBI)/National Institutes of Health (NIH).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2013
Longer than P75 for phase_3
470 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 1, 2012
CompletedFirst Posted
Study publicly available on registry
May 9, 2012
CompletedStudy Start
First participant enrolled
April 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 15, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2019
CompletedResults Posted
Study results publicly available
July 24, 2020
CompletedJuly 24, 2020
July 1, 2020
6 years
May 1, 2012
June 20, 2020
July 23, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of Subjects With Major Adverse Cardiovascular Events
The first occurrence of Major Adverse Cardiovascular Event which is defined as the occurrence of one or more of the following: Cardiovascular Death, Non-Fatal Myocardial Infarction or Non-Fatal Stroke.
From randomization to trial end (April 2, 2018) up to a maximum of 5 years
Number of Subjects With Major Adverse Cardiovascular Event or Hospitalization for Unstable Angina That Led to Urgent Coronary Revascularization
The first occurrence of Major Adverse Cardiovascular Event or Hospitalization for Unstable Angina that led to Urgent Coronary Revascularization.
From randomization to trial end (April 2, 2018) - up to a maximum of 5 years
Secondary Outcomes (5)
Number of Subjects With All-cause Mortality
From randomization to the trial end (April 2, 2018) up to a maximum of 5 years
Number of Subjects With Major Adverse Cardiovascular Event or Any Coronary Revascularization
From randomization to the trial end (April 2, 2018) - up to a maximum of 5 years
Number of Subjects With Hospitalization for Congestive Heart Failure
From randomization to trial end (April 2, 2018) up to a maximum of 5 years
Number of Subjects With Major Adverse Cardiovascular Event, Coronary Revascularization, Hospitalization for Congestive Heart Failure or All Cause Mortality
From randomization to trial end (April 2, 2018) up to a maximum of 5 years
Number of Subjects With New Onset Type 2 Diabetes
From randomization to the trial end (April 2, 2018) - up to 5 years
Other Outcomes (6)
Number of Subjects With Hospitalization for Unstable Angina That Led to Unplanned Coronary Revascularization
From randomization to the trial end (April 2, 2018) up to 5 years
Number of Subjects With Coronary Revascularization
From randomization to trial end (April 2, 2018) up to 5 years
Number of Subjects With Peripheral Artery Disease
From randomization to the trial end (April 2, 2018) - up to 5 years
- +3 more other outcomes
Study Arms (2)
Methotrexate
EXPERIMENTALMethotrexate: Tablet, Oral, Target dose 15-20mg weekly plus 1.0 mg folic acid 6 days/week
Placebo
PLACEBO COMPARATORPlacebo: Tablet, Oral weekly plus 1.0mg folic acid 6 days/week
Interventions
Tablet, Oral, Target dose 15-20 mg weekly plus 1.0 mg folic acid 6 days/week
Eligibility Criteria
You may qualify if:
- Age ≥ 18 years at screening
- Documented past history of myocardial infarction OR past evidence of multivessel coronary artery disease by angiography.
- To qualify on the basis of past history of myocardial infarction, the event must be documented either by hospital records or by evidence on current ECG of Q waves in two contiguous leads and/or an imaging test demonstrating wall motion abnormality or scar. The patient must also have completed any planned coronary revascularization procedures associated with the qualifying event, and be clinically stable for at least 60 days prior to screening.
- To qualify on the basis of multivessel coronary disease, there must be past angiographic evidence of atherosclerosis in at least 2 major epicardial vessels defined either as the presence of a stent, a coronary bypass graft, or an angiographic lesion of 60% or greater. Left main coronary artery disease that has been revascularized with a stent or bypass graft will qualify as multivessel disease, as will the presence of a 50% or greater isolated left main stenosis. The patient must also have completed any planned coronary revascularization procedures associated with the qualifying event, and be clinically stable for at least 60 days prior to screening.
- History of type 2 diabetes or metabolic syndrome at time of study enrollment
- Willingness to participate as evidenced by signing the study informed consent
You may not qualify if:
- Prior history of chronic infectious disease, tuberculosis, or severe fungal disease; chronic hepatitis B or C infection; renal insufficiency; interstitial pneumonitis, bronchiectasis, or pulmonary fibrosis; known chronic pericardial effusion, pleural effusion, or ascites; chronic liver disease; myeloproliferative disorders in the past 5 years; non-basal cell malignancy or treated lymphoproliferative disease within the past 5 years; known HIV positive; life expectancy of \< 3 years;
- Chronic inflammatory condition such as lupus or rheumatoid arthritis, ulcerative colitis or Crohn's disease
- White blood cell count \< 3,500/ul, hematocrit \< 32 percent, or platelet count \< 75,000/ul
- Liver transaminase levels (AST or ALT) \>upper limit of normal (ULN) or albumin \< the lower limit of normal (LLN);
- Creatinine clearance \< 40 ml/min as estimated with the Cockcroft-Gault equation;
- History of alcohol abuse or unwillingness to limit alcohol consumption to less than 4 drinks per week
- Women of child bearing potential, even if they are currently using contraception, and women intending to breastfeed.
- Men who plan to father children during the study period or who are unwilling to use effective forms of contraception.
- Requirement for use of drugs that alter folate metabolism (trimethoprim/sulfamethoxazol) or reduce tubular excretion (probenecid) or known allergies to antibiotics making avoidance of trimethoprim impossible;
- Current indication for methotrexate therapy;
- Chronic use of oral steroid therapy or other immunosuppressive or biologic response modifiers. Eligible study participants will be encouraged to have up to date pneumococcal and influenza vaccinations as recommended based on their age and underlying medical conditions.
- Chest X-ray evidence in the past 12 months of interstitial pneumonitis, bronchiectasis, or pulmonary fibrosis. For participants who do not have a chest X-ray in the prior 12 months, a chest X-ray will be obtained at baseline as part of the study protocol.
- New York Heart Association Class IV congestive heart failure.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (470)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Appalachian Research Associates
Fort Payne, Alabama, 35967, United States
Avant Research Associates, LLC
Guntersville, Alabama, 35976, United States
Saadat Ansari MD LLC
Huntsville, Alabama, 35801, United States
University of South Alabama: Division of Clinical Research
Mobile, Alabama, 36617, United States
Heart Vascular of Northern Arizona
Cottonwood, Arizona, 86326, United States
CardioVascular Associates of Mesa
Mesa, Arizona, 85206, United States
Arizona Arthritis & Rheumatology Research
Phoenix, Arizona, 85032, United States
Scottsdale Medical Imaging
Scottsdale, Arizona, 85258, United States
The Heart Clinic
Scottsdale, Arizona, 85258, United States
Pima Heart
Tucson, Arizona, 85718, United States
Southern Arizona VA Health Care System
Tucson, Arizona, 85723, United States
Arkansas Cardiology
Little Rock, Arkansas, 72205, United States
Arkansas Heart Hospital
Little Rock, Arkansas, 72211, United States
Oracle Clinical Research, Inc.
Anaheim, California, 92801, United States
Medical Group of Culver City
Culver City, California, 90230, United States
Touro University California- Solano County Affiliated Clinics
Fairfield, California, 94533, United States
University Of California San Francisco
Fresno, California, 93701, United States
VACCHCS
Fresno, California, 93703, United States
UCSD Sulpizio Cardiovascular Center
La Jolla, California, 92037, United States
University Of California San Diego
La Jolla, California, 92093, United States
Desert Medical Care & Wellness
La Quinta, California, 92253, United States
Kumar Medical Corporation
Lancaster, California, 93534, United States
Loma Linda University Health
Loma Linda, California, 92354, United States
VA Loma Linda Healthcare System
Loma Linda, California, 92357, United States
Long Beach Center for Clinical Research
Long Beach, California, 90807, United States
Cardiovascular Innovation and Research
Long Beach, California, 90813, United States
Los Alamitos Cardiovascular
Los Alamitos, California, 90720, United States
Faye Montegrande Md. Clinical Research
Los Angeles, California, 90004, United States
Eastside Clinical Research Associates
Los Angeles, California, 90022, United States
Salman Khan A. Medical Corporation
Los Angeles, California, 90033, United States
University of Southern California
Los Angeles, California, 90033, United States
West LA VA Medical Center
Los Angeles, California, 90049, United States
VA Northern California Health Care
Mather, California, 95655, United States
Valley Clinical Trials, Inc.
Northridge, California, 91325, United States
Orange County Heart Institute & Research
Orange, California, 92868, United States
University of CA Irvine Medical Center
Orange, California, 92868, United States
Diverse Research Solutions
Oxnard, California, 93030, United States
Huntington Memorial Hospital
Pasadena, California, 91105, United States
Central Coast Cardiology
Salinas, California, 93901, United States
Richard G. Friedman, MD
San Diego, California, 92103, United States
Ritchken and First MDs
San Diego, California, 92117, United States
Foundation for Cardiovascular Medicine
San Diego, California, 92121, United States
San Diego Cardiac Center
San Diego, California, 92123, United States
Veterans Affairs San Diego Healthcare System
San Diego, California, 92161, United States
UCSF at Zuckerberg SF General Hospital
San Francisco, California, 94110, United States
Coastal Heart Medical Group, Inc.
Santa Ana, California, 92704, United States
Comprehensive Cardiovascular Care
Santa Maria, California, 93454, United States
Pacific Heart and Vascular Medical Group
Stockton, California, 95210, United States
Manoj D. Aswani M.D.
Thousand Oaks, California, 91360, United States
Touro University California- Solano Public Health Affiliated Clinics
Vallejo, California, 94592, United States
Munni R. Selagamsetty, Md, Pc
Colorado Springs, Colorado, 80910, United States
Vijay - Aurora Denver Cardiology
Denver, Colorado, 80218, United States
Colorado Health Medical Group Heart Center of the Rockies
Fort Collins, Colorado, 80528, United States
Medical Center of the Rockies Research
Fort Collins, Colorado, 80528, United States
Unrein - Rocky Vista University Health Center
Parker, Colorado, 80134, United States
Connecticut Heart and Vascular Center
Bridgeport, Connecticut, 06606, United States
Bridgeport Hospital
Bridgeport, Connecticut, 06610, United States
Cardiology Physicians/Red Clay Research
Newark, Delaware, 19713, United States
Boisey Barnes MD, PC
Washington D.C., District of Columbia, 20024, United States
GWU Medical Faculty Associatin, Inc.
Washington D.C., District of Columbia, 20037, United States
Pianko - Aventura Research Center, LLC
Aventura, Florida, 33180, United States
North Ridge Heart Associates
Boca Raton, Florida, 33434, United States
St. Francis Medical Institute
Clearwater, Florida, 33765, United States
Gonzalez MD & Aswad MD Health Ser
Coral Gables, Florida, 33134, United States
American Research Institute, Inc.
Cutler Bay, Florida, 33157, United States
Daytona Heart Group
Daytona Beach, Florida, 32114, United States
Daytona Heart Group
DeLand, Florida, 32720, United States
Seidman Clinical Trials
Delray Beach, Florida, 33484, United States
Steven Cohen MD
Delray Beach, Florida, 33484, United States
Infinite Clinical Research
Doral, Florida, 33126, United States
International Research Partners, LLC
Doral, Florida, 33166, United States
Medical Research Institute at Doral, Inc.
Doral, Florida, 33178, United States
Lake Internal Medicine Assocaties
Eustis, Florida, 32726, United States
Invesclinic
Fort Lauderdale, Florida, 33308, United States
Primary Care Associates
Fort Myers, Florida, 33907, United States
Lee Physician Group
Fort Myers, Florida, 33908, United States
The Cardiac and Vascular Institute
Gainesville, Florida, 32605, United States
University of Florida
Gainesville, Florida, 32610, United States
Qway Research
Hialeah, Florida, 33010, United States
State of the Art Research
Hialeah, Florida, 33010, United States
Healing Touch C&C Research
Hialeah, Florida, 33012, United States
Luzmed Clinical Research Institute
Hialeah, Florida, 33012, United States
Viviana Perez MD Research & Cosmetics
Hialeah, Florida, 33012, United States
Elite Cardiac Research Center LLC
Hialeah, Florida, 33013, United States
Nova Clinical Research Clinic
Hialeah, Florida, 33013, United States
Best Quality Research, Inc.
Hialeah, Florida, 33016, United States
South Florida Research Solutions, LLC
Hollywood, Florida, 33021, United States
John Gutleber Medical Research Office
Homestead, Florida, 33030, United States
Cardiovascular Medical Associates of Palm Beach
Jupiter, Florida, 33458, United States
Hope Clinical Research
Kissimmee, Florida, 34758, United States
SIH Research, LLC
Kissimmee, Florida, 34759, United States
Medical Research Center of Florida
Miami, Florida, 33122, United States
LG Diagnostics, Inc.
Miami, Florida, 33126, United States
St. Paul Medical Research Center, Inc.
Miami, Florida, 33126, United States
Team Medical Research
Miami, Florida, 33134, United States
Paradise Clinical Research, LLC
Miami, Florida, 33144, United States
GAD Research Center
Miami, Florida, 33155, United States
Innovation Research Institute, Inc.
Miami, Florida, 33155, United States
Sanitas Research
Miami, Florida, 33155, United States
Segui - Med Care Research
Miami, Florida, 33165, United States
South Florida Research Group, LLC
Miami, Florida, 33176, United States
Vista Health Research, LLC
Miami, Florida, 33176, United States
D De La Vega MD Research Group
Miami, Florida, 33186, United States
Lakes Research, LLC
Miami Lakes, Florida, 33014, United States
Veritas Research Corp.
Miami Lakes, Florida, 33014, United States
Ocean Blue Medical Research Center
Miami Springs, Florida, 33166, United States
Southwest Florida Research, LLC
Naples, Florida, 34102, United States
Orlando Healthy Heart Institute
Orlando, Florida, 32806, United States
Palm Beach Gardens Research Center, LLC
Palm Beach Gardens, Florida, 33410, United States
Broward Research Center
Pembroke Pines, Florida, 33024, United States
Pioneer Clinical Research
Pembroke Pines, Florida, 33024, United States
Sandoval - Broward Research Center
Pembroke Pines, Florida, 33204, United States
Bay Area Heart Center: 49th Street
St. Petersburg, Florida, 33705, United States
Bay Area Heart Center: 7th Avenue
St. Petersburg, Florida, 33705, United States
Lenus Research & Medical Group
Sweetwater, Florida, 33172, United States
DBC Research
Tamarac, Florida, 33321, United States
Asclepes Research Centers
Weeki Wachee, Florida, 34607, United States
Gupta - Premier Heart and Vascular Center
Wesley Chapel, Florida, 33544, United States
Athens Regional Medical Center
Athens, Georgia, 30606, United States
Atlanta Veterans Affairs Medical Center
Atlanta, Georgia, 30033, United States
Laureate Medical Group at Northside
Atlanta, Georgia, 30308, United States
Synergy Therapeutic Partners
Atlanta, Georgia, 30308, United States
Northside Hospital
Atlanta, Georgia, 30342, United States
Atlanta Heart Specialists, LLC
Cumming, Georgia, 30041, United States
Heart and Rhythm Specialists
Dalton, Georgia, 30720, United States
Albert F. Johary MD, PC
Dunwoody, Georgia, 30338, United States
Infinite Clinical Trials
Riverdale, Georgia, 30274, United States
Atlanta Vanguard Medical Associates
Smyrna, Georgia, 30082, United States
Herman Clinical Research, LLC
Suwanee, Georgia, 30024, United States
Atlanta Heart Specialists, LLC
Tucker, Georgia, 30084, United States
Cardiology Associates of Vidalia, P.C.
Vidalia, Georgia, 30474, United States
VA Pacific Islands Health Care System
Honolulu, Hawaii, 96819, United States
St. Luke's Idaho Cardiology Associates
Boise, Idaho, 83712, United States
Clinical Research Prime
Idaho Falls, Idaho, 83404, United States
Northwest Heart Clinical Research
Arlington Heights, Illinois, 60005, United States
University of Chicago Medical Center
Chicago, Illinois, 60637, United States
Advocate Med Group-Heart & Vascular Of Illinois
Chicago, Illinois, 60657, United States
Illinois Heart & Lung Research Center, SC
Normal, Illinois, 61761, United States
Captain James A. Lovell Federal Health
North Chicago, Illinois, 60064, United States
Specialty Physicians of Illinois, LLC
Olympia Fields, Illinois, 60461, United States
Advanced CardioVascular Consultants
Rock Island, Illinois, 61201, United States
Cardiospecialists, LTD
Dyer, Indiana, 46311, United States
Martin - Martin Family Practice and Research
Evansville, Indiana, 47714, United States
Krannert Institute Of Cardiology
Indianapolis, Indiana, 46202, United States
Community Hospital South
Indianapolis, Indiana, 46227, United States
Indiana Heart Physicians
Indianapolis, Indiana, 46237, United States
Medical Consultants, PC
Muncie, Indiana, 47303, United States
Iowa Heart Center
West Des Moines, Iowa, 50266, United States
Stahl - Midwest Heart & Vascular Specialists
Overland Park, Kansas, 66209, United States
Professional Research Network of KS
Wichita, Kansas, 67203, United States
Robert J. Dole VAMC
Wichita, Kansas, 67230, United States
University of Kentucky
Lexington, Kentucky, 40536, United States
Robley Rex VAMC
Louisville, Kentucky, 40202, United States
Stoddard - University of Louisville
Louisville, Kentucky, 40202, United States
Bays - L-MARC Research Center
Louisville, Kentucky, 40213, United States
Research Integrity LLC
Owensboro, Kentucky, 42303, United States
Dorothy H. Banish, MD, APMC Study Group
Covington, Louisiana, 70433, United States
Avant Research Associates, LLC
Crowley, Louisiana, 70526, United States
North Oaks Cardiology
Hammond, Louisiana, 70403, United States
American Clinical Research, LLC
Marrero, Louisiana, 70072, United States
Otis Barnum D.O.P.C.
Natchitoches, Louisiana, 71457, United States
Tulane University Office of Health Research
New Orleans, Louisiana, 70112, United States
Veterans Affairs Medical Center Shreveport
Shreveport, Louisiana, 71101, United States
Maine Research Associates
Auburn, Maine, 04210, United States
Paul A. Shapero, M.D.
Bangor, Maine, 04401, United States
Southern Maine Health Care
Biddeford, Maine, 04005, United States
InterMed, PA
Portland, Maine, 04101, United States
Maine Medical Partners Maine Health Cardiology
South Portland, Maine, 04106, United States
Maine Centers for Healthcare
Westbrook, Maine, 04092, United States
Sinai Center for Thrombosis Research
Baltimore, Maryland, 21215, United States
St. Mary's Medical Center
Charlotte Hall, Maryland, 20622, United States
Calvert Memorial Hospital
Clinton, Maryland, 20735, United States
Shah Associates, MD, LLC
Prince Frederick, Maryland, 20678, United States
Peninsula Cardiology Associates
Salisbury, Maryland, 21804, United States
IRC Clinics
Towson, Maryland, 21204, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
St. Elizabeth's Medical Center
Boston, Massachusetts, 02135, United States
MGH Cardiology
Boston, Massachusetts, 02214, United States
Joslin Diabetes Center
Boston, Massachusetts, 02215, United States
Lahey Hospital and Medical Center
Burlington, Massachusetts, 01805, United States
Massachusetts General Hospital - Chelsea Health Care Center
Chelsea, Massachusetts, 02150, United States
Pentucket Medical Associates, Inc.
Haverhill, Massachusetts, 01830, United States
VA Central Western Massachusetts Healthca
Leeds, Massachusetts, 01053, United States
South Shore Internal Medicine
Milton, Massachusetts, 02186, United States
Lahey Medical Center
Peabody, Massachusetts, 02149, United States
North Shore Cardiovascular Associates
Salem, Massachusetts, 01907, United States
Reliant Medical Group
Worcester, Massachusetts, 01608, United States
Endeavor Medical Research
Alpena, Michigan, 49707, United States
John D. Dingell Veterans Affairs Medical Center
Detroit, Michigan, 48201, United States
Trace Research Group at Wayne State University
Detroit, Michigan, 48201, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Flint Clinical Research
Flint, Michigan, 48503, United States
Apex Medical Research MI, Inc.
Flint, Michigan, 48504, United States
Garden City Hospital
Garden City, Michigan, 48135, United States
Genesys Regional Medical Center
Grand Blanc, Michigan, 48439, United States
National Clinical LLC
Hamtramck, Michigan, 48212, United States
Academic Cardiology Associates PC
Rochester Hills, Michigan, 48307, United States
Beaumont Health Center
Royal Oak, Michigan, 48073, United States
Covenant Medical Center, Inc.
Saginaw, Michigan, 48602, United States
Mid-Michigan Heart & Vascular Center
Saginaw, Michigan, 48609, United States
Centra Care Heart & Vascular Center at St. Cloud Hospital
Saint Cloud, Minnesota, 56303, United States
United Heart and Vascular Clinic
Saint Paul, Minnesota, 55102, United States
Gulfside Clinical Research, LLC
Gulfport, Mississippi, 39501, United States
University of MS Medical Center
Jackson, Mississippi, 39216, United States
David M. Headley M.D. PA Planters Clinic
Port Gibson, Mississippi, 39150, United States
Stern Cardiovascular Foundation, Inc.
Southaven, Mississippi, 38671, United States
Center for Advanced Medicine and Research LLC
Bridgeton, Missouri, 63044, United States
Center for Advanced Medicine and Research
City of Saint Peters, Missouri, 63303, United States
Clinical Research Center University of Missouri
Columbia, Missouri, 65212, United States
Quantum Research LLC
Festus, Missouri, 63028, United States
Midwest Cardiology Associates
Independence, Missouri, 64057, United States
Freeman Health System
Joplin, Missouri, 64804, United States
VA Medical Center Kansas City
Kansas City, Missouri, 64128, United States
Lake Regional Cardiovascular Institute
Osage Beach, Missouri, 65065, United States
CoxHealth: Wheeler Heart & Vascular Center
Springfield, Missouri, 65807, United States
Mercy Medical Research Institute
Springfield, Missouri, 65807, United States
VA St. Louis Health Care System (VASTLHCS)
St Louis, Missouri, 63106, United States
SLUCare Cardiology
St Louis, Missouri, 63110, United States
Washington University
St Louis, Missouri, 63110, United States
Clinical Investigators LLC
St Louis, Missouri, 63119, United States
Consult and Research Associates
St Louis, Missouri, 63122, United States
Great Falls Clinic Clinical Research Deptartment
Great Falls, Montana, 59420, United States
Cone - Montana Medical Research
Missoula, Montana, 59801, United States
Barrett Clinic, P.C.
La Vista, Nebraska, 68128, United States
Heart Consultants
Omaha, Nebraska, 68114, United States
Alegent Creighton Health
Omaha, Nebraska, 68131, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Internal Medicine Clinic
Las Vegas, Nevada, 89102, United States
Red Rock Clinical Research, LLC
Las Vegas, Nevada, 89146, United States
Sierra Nevada Health Care System
Reno, Nevada, 89502, United States
Renown Inst for Heart & Vasc Health
Reno, Nevada, 89503, United States
Lahey Cardiology
Nashua, New Hampshire, 03060, United States
Family Health at Mount Olive
Flanders, New Jersey, 07836, United States
Cardiocare
Hillsborough, New Jersey, 08844, United States
New Jersey Heart
Linden, New Jersey, 07063, United States
Jersey Shore University Medical Center
Neptune City, New Jersey, 07753, United States
Cardiovascular Institute
New Brunswick, New Jersey, 08901, United States
Palisade Medical Center
North Bergen, New Jersey, 07047, United States
The Valley Hospital
Ridgewood, New Jersey, 07450, United States
Mercer Bucks Cardiology
Robbinsville, New Jersey, 08691, United States
Cardio Metabolic Institute
Somerset, New Jersey, 08873, United States
Holy Name Medical Center, Inc.
Teaneck, New Jersey, 07666, United States
Total Cardiology Care, LLC
Wayne, New Jersey, 07470, United States
Westwood Cardiology Associates
Westwood, New Jersey, 07675, United States
Presbyterian Heart Group
Albuquerque, New Mexico, 87106, United States
Albany Medical College
Albany, New York, 12208, United States
Albany Stratton VA Medical Center
Albany, New York, 12208, United States
Brown - SUNY Downstate Medical Center
Brooklyn, New York, 11203, United States
Buffalo Heart Group
Buffalo, New York, 14215, United States
Bassett Healthcare Network
Cooperstown, New York, 13326, United States
NYU Hudson Valley Cardiology
Cortlandt Manor, New York, 10567, United States
NYHQ
Flushing, New York, 11355, United States
Jamaica Hospital Medical Center
Jamaica, New York, 11418, United States
Long Island Heart Associates
Mineola, New York, 11501, United States
Winthrop University Hospital
Mineola, New York, 11501, United States
Long Island Jewish Medical Center
New Hyde Park, New York, 11040, United States
Queens Long Island Medical Group
New Hyde Park, New York, 11577, United States
Chinatown Cardiology, PC
New York, New York, 10013, United States
Weill Cornell Medical College and NY Presbyterian
New York, New York, 10021, United States
Mount Sinai School of Medicine
New York, New York, 10029, United States
DiGiovanna Institute for Medical Education and Research
North Massapequa, New York, 11758, United States
Champlain Valley Physician Hospital
Plattsburgh, New York, 12901, United States
Cardiology Associates of Schenectady
Schenectady, New York, 12309, United States
Novel Research of New York, LLC
The Bronx, New York, 10461, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
Clinical Study Center of Asheville
Asheville, North Carolina, 28801, United States
Metrolina Internal Medicine
Charlotte, North Carolina, 28204, United States
Gaffney Health Services
Charlotte, North Carolina, 28205, United States
Carolinas Research Center
Charlotte, North Carolina, 28215, United States
Eastern Carolina Cardiovascular, PA
Elizabeth City, North Carolina, 27909, United States
Eastern Cardiology
Greenville, North Carolina, 27834, United States
Northside Clinical Research
Lenoir, North Carolina, 28645, United States
Lake Shore Clinical Research, LLC.
Mooresville, North Carolina, 28117, United States
Carteret Medical Group
Morehead City, North Carolina, 28557, United States
Cardiology Associates of Carolinas, PA
Morganton, North Carolina, 28655, United States
Eastern Nephrology Associates, PLLC
New Bern, North Carolina, 28562, United States
Boice Willis Clinic
Rocky Mount, North Carolina, 27804, United States
Sanford Cardiology
Sanford, North Carolina, 27330, United States
Natalie A. Doyle, MD, PA
Wilson, North Carolina, 27893, United States
Altru Health System Rehab Center
Grand Forks, North Dakota, 58201, United States
Akron General Medical Center
Akron, Ohio, 44307, United States
Ohio University Heritage College of Osteopathic Medicine
Athens, Ohio, 45701, United States
Diabetes and Endocrinology Associates of Stark Cit
Canton, Ohio, 44718, United States
The Lindner Research Center
Cincinnati, Ohio, 45219, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Optimed Research, LTD
Columbus, Ohio, 43235, United States
Dayton Heart Center
Dayton, Ohio, 45414, United States
Dayton Veteran Affairs Medical Center
Dayton, Ohio, 45428, United States
Colonnade Medical Group
Lancaster, Ohio, 43130, United States
Middletown Cardiovascular Associates
Middletown, Ohio, 45044, United States
Comprehensive Heart Care, Inc.
Toledo, Ohio, 43606, United States
Mount Carmel Clinical Cardiovascular Care
Westerville, Ohio, 43081, United States
Premier Physicians
Westlake, Ohio, 44154, United States
Wooster Heart Group
Wooster, Ohio, 44691, United States
Unity Clinical Research
Lindsay, Oklahoma, 73052, United States
COR Clinical Research, LLC
Oklahoma City, Oklahoma, 73103, United States
Thadani - VA Medical Center Oklahoma City, OK
Oklahoma City, Oklahoma, 73104, United States
Today Clinical Research
Oklahoma City, Oklahoma, 73129, United States
Cardiovascular Health Clinic
Oklahoma City, Oklahoma, 73134, United States
Oklahoma State University Center for Health Sciences
Tulsa, Oklahoma, 74127, United States
Samaritan Health Services
Corvallis, Oregon, 97330, United States
Southern Oregon Cardiology, LLC
Medford, Oregon, 97504, United States
Oregon Health & Science University
Portland, Oregon, 97239, United States
Center for Clinical Res. Abington Health
Abington, Pennsylvania, 19001, United States
St. Luke's University Hospital
Bethlehem, Pennsylvania, 18018, United States
Renu-Ca Research Institute, Lower Bucks Hospital
Bristol, Pennsylvania, 19007, United States
Main Line Health Center, Broomall
Broomall, Pennsylvania, 19008, United States
Spirit Physician Services, Inc
Camp Hill, Pennsylvania, 17011, United States
The Chambersburg Hospital
Chambersburg, Pennsylvania, 17201, United States
Central Bucks Cardiology
Doylestown, Pennsylvania, 18901, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635, United States
Heart Specialists of Lancaster County
Ephrata, Pennsylvania, 17522, United States
Saint Vincent Consultants in Cardiovascular Diseases, LLC
Erie, Pennsylvania, 16502, United States
Feasterville Family Healthcare Center
Feasterville, Pennsylvania, 19053, United States
Christiana Care Health System
Glen Mills, Pennsylvania, 19342, United States
Pinnacle Health Cardiovascular Institute
Harrisburg, Pennsylvania, 17110, United States
George Isajiw, MD
Lansdowne, Pennsylvania, 19050, United States
Bucks County Clinical Research
Morrisville, Pennsylvania, 19067, United States
Drexel University College of Medicine
Philadelphia, Pennsylvania, 19102, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Lehigh Valley Health Services
Sellersville, Pennsylvania, 18960, United States
Pish Medical Associates, Inc.
Uniontown, Pennsylvania, 15401, United States
Lehigh Valley Family Practice
Whitehall, Pennsylvania, 18052, United States
Wilkes-Barre VA Medical Center
Wilkes-Barre, Pennsylvania, 18711, United States
Partners in Clinical Research
Cumberland, Rhode Island, 02864, United States
Ocean State Clinical Research Prtnr
Lincoln, Rhode Island, 02865, United States
Memorial Hospital of Rhode Island
Pawtucket, Rhode Island, 02860, United States
The Miriam Hospital
Providence, Rhode Island, 02906, United States
Ocean State Research Institute, Inc
Providence, Rhode Island, 02908, United States
South Carolina Heart Center
Columbia, South Carolina, 29204, United States
Amistad Research Center, LLC
Columbia, South Carolina, 29223, United States
Miller - SC Internal Medicine Associates.: Irmo
Irmo, South Carolina, 29063, United States
Charlotte Hearts
Old Point Station, South Carolina, 29707, United States
Inlet Cardiopulmonary & Associates
Pawleys Island, South Carolina, 29585, United States
Fusion Clinical Research of Spartanburg
Spartanburg, South Carolina, 29301, United States
Palmetto Research Center, LLC
Spartanburg, South Carolina, 29302, United States
New Phase Research & Development
Chattanooga, Tennessee, 37409, United States
Parkway Medical Group
Fayetteville, Tennessee, 37334, United States
Stern Cardiovascular Foundation, Inc.
Germantown, Tennessee, 38138, United States
Kore Cardiovascular Research Institutue
Jackson, Tennessee, 38305, United States
New Phase Research & Development
Knoxville, Tennessee, 37909, United States
Cardiovascular Research of Knoxville
Knoxville, Tennessee, 37917, United States
Ramanathan - VAMC Memphis
Memphis, Tennessee, 38104, United States
Clinical Research Center Meharry Medical College
Nashville, Tennessee, 37208, United States
Avant Research Associates LLC
Austin, Texas, 78704, United States
Texas Heart and Vascular Research, LLC
Austin, Texas, 78745, United States
Southeast TX Clinical Research Center
Beaumont, Texas, 77702, United States
Cornerstone Family Medicine
Big Spring, Texas, 79720, United States
IMD Medical Center
Carrollton, Texas, 75006, United States
Texas Health Physicians Group
Carrollton, Texas, 75010, United States
Cardiovascular Research Institute of Dallas
Dallas, Texas, 75231, United States
North Texas Health Center
Dallas, Texas, 75231, United States
The Heart Center of Dallas
Dallas, Texas, 75235, United States
Global Medical Research
DeSoto, Texas, 75115, United States
The Medical Group of Texas
Fort Worth, Texas, 76104, United States
Texas Health Physicians Group
Fort Worth, Texas, 76107, United States
T&R Clinic, P.A.
Haltom City, Texas, 76117, United States
Michele P. Sartori, MD
Houston, Texas, 77030, United States
Grand Medical Care
Katy, Texas, 77494, United States
Team Research Of Central Texas
Killeen, Texas, 76543, United States
Houston Heart and Vascular Associates
Kingwood, Texas, 77339, United States
Grace Research, LLC
Marshall, Texas, 75670, United States
Valley Heart Consultants
McAllen, Texas, 78503, United States
Heart Center, Palo Pinto General Hospital
Mineral Wells, Texas, 76067, United States
Valley Central Research Inc
Mission, Texas, 78572, United States
North Hills Medical Research, Inc
North Richland Hills, Texas, 76180, United States
Grace Research, LLC
Palestine, Texas, 75801, United States
Avant Research Associates, LLC
Port Arthur, Texas, 77640, United States
Santoscoy - Health Texas Research Institute
San Antonio, Texas, 78212, United States
Element Research Group
San Antonio, Texas, 78229, United States
Schnitzler Cardiovascular Consultants
San Antonio, Texas, 78229, United States
San Antonio Endovascular & Heart Institute
San Antonio, Texas, 78268, United States
Acacia Medical Research Institute
Sugar Land, Texas, 77478, United States
Health Plus Clinical Research
Sugar Land, Texas, 77478, United States
Lone Star Heart and Vascular Center
Tomball, Texas, 77375, United States
Northwest Houston Clinical Research
Tomball, Texas, 77375, United States
Hillcrest Family Health Center
Waco, Texas, 76710, United States
Utah Cardiology, P.C.
Layton, Utah, 84041, United States
Utah Diabetes Center
Salt Lake City, Utah, 84108, United States
VA Medical Center, White River Junction
White River Junction, Vermont, 05009, United States
Burke Internal Medicine & Research
Burke, Virginia, 22015, United States
Seven Corners Medical Research Center
Falls Church, Virginia, 22044, United States
Hampton Family Practice Research
Hampton, Virginia, 23666, United States
Tidewater Physicians Multispecialty Group
Hampton, Virginia, 23666, United States
Virginia Cardiovascular Associates
Manassas, Virginia, 20109, United States
Manassas Clinical Research Center
Manassas, Virginia, 20110, United States
Tucker Cardiology Associates, P.C.
Mechanicsville, Virginia, 23116, United States
TPMG Clinical Research
Newport News, Virginia, 23606, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507, United States
Roanoke Heart Institute PLC
Roanoke, Virginia, 24014, United States
Cardinal Internal Medicine Associates
Woodbridge, Virginia, 22192, United States
Tidewater Physicians Multispecialty Group
Yorktown, Virginia, 23690, United States
Frandsen Family Medicine DBA Sound Medi
Port Orchard, Washington, 98366, United States
Premier Clinical Research
Spokane, Washington, 99202, United States
Kootenai Heart Clinics, LLC
Spokane, Washington, 99204, United States
Northside Internal Medicine
Spokane, Washington, 99208, United States
Northwest Medical Associates, P.S.
Vancouver, Washington, 98684, United States
Cardiology Associates of Bellin Health
Green Bay, Wisconsin, 54115, United States
Dean Foundation
Madison, Wisconsin, 53715, United States
University Of Wisconsin
Madison, Wisconsin, 53715, United States
Marshfield Clinic
Marshfield, Wisconsin, 54449, United States
Columbia St. Mary's
Milwaukee, Wisconsin, 53211, United States
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, 53215, United States
The Medical Arts Health Research Group
North Vancouver, British Columbia, V7M 2H4, Canada
The Medical Arts Health Research Group
Penticton, British Columbia, V2A 5C8, Canada
Winnipeg Clinic
Winnipeg, Manitoba, R3C 0N2, Canada
Bramalea Medical Centre
Brampton, Ontario, L6T 4S5, Canada
Brampton Research Associates
Brampton, Ontario, L6Z 4N5, Canada
Philippe R Beaudry Medicine Professional Corporation
Burlington, Ontario, L7R 4E2, Canada
Vizel Cardiac Research
Cambridge, Ontario, N1R7R1, Canada
Dr. Linda Sinnaeve's Office
Chatham, Ontario, N7L 1C1, Canada
Scisco Clinical Research
Cornwall, Ontario, K6H 4M4, Canada
G.S. Cardiac Lab Medicine Professional Corp
Greater Sudbury, Ontario, P3C 1S8, Canada
Dr. R. Labonte Professional Med Corp
Greater Sudbury, Ontario, P3E 3B8, Canada
Dr. G. Garrioch, Independent Practice
Greater Sudbury, Ontario, P3E 3C6, Canada
Dr. Peter Spadafora Health Center
Guelph, Ontario, N1E 5G6, Canada
John Stimac, MD
Hamilton, Ontario, L8L 5G4, Canada
KMH Cardiology & Diagnostics: Hamilton
Hamilton, Ontario, L8P 3A9, Canada
Dr. William Liang
Hamilton, Ontario, L8W3J6, Canada
Source Unique Clinic
Hawkesbury, Ontario, K6A 1A1, Canada
Dr. Ronald Fowlis
Kitchener, Ontario, N2M 5NG, Canada
University Hospital
London, Ontario, N6A 5A5, Canada
Malton Medical Research
Mississauga, Ontario, L4T 4J2, Canada
KMH Cardiology & Diagnostics: Mississauga
Mississauga, Ontario, L5K 2L3, Canada
Sewa Ram Singal Medicine Professional Corporation
Mississauga, Ontario, L5U 0A6, Canada
Newmarket Cardiology Research Group
Newmarket, Ontario, l3y -8c3, Canada
Newmarket Cardiology Research Group
Newmarket, Ontario, L3Y 8C3, Canada
Portage Medical Centre
Niagara Falls, Ontario, I2E6A6, Canada
Humber River Regional Hospital
North York, Ontario, M3N2V6, Canada
Bakbak Medicine Professional Corporation
Oshawa, Ontario, L1H 1B9, Canada
Dr. James Y. Cha
Oshawa, Ontario, L1J2K1, Canada
University Of Ottawa Heart Institute
Ottawa, Ontario, k1y -4w7, Canada
Kawartha Cardiology Clinical Trials
Peterborough, Ontario, K9J0B2, Canada
Steeple Hill Medical Centre
Pickering, Ontario, L1V 2A6, Canada
Sarnia Institute Of Clinical Research
Sarnia, Ontario, N7T 4X3, Canada
Scarborough Cardiology Research
Scarborough Village, Ontario, M1E5E9, Canada
Scarborough General Hospital Cardiology Research Associates
Scarborough Village, Ontario, M1PT27, Canada
Milliken Medical Centre
Scarborough Village, Ontario, M1V5P6, Canada
Canadian Centre for Research on Diabetes
Smith Falls, Ontario, K7A 4W8, Canada
Lake Shore Cardiology
St. Catharines, Ontario, L2S 2Y3, Canada
Sardar Medical Clinic
St. Thomas, Ontario, N5R 2R4, Canada
Dr. Laurence Gibbs Medicine Professional Corp.
Thedford, Ontario, N0M 2N0, Canada
Tillsonburg Medical Centre
Tillsonburg, Ontario, N4G 5A7, Canada
Humber River Hospital
Toronto, Ontario, M3M 0B2, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5, Canada
St. Michael's Hospital
Toronto, Ontario, M5B 1W8, Canada
Mount Sinai Hospital
Toronto, Ontario, M5G 1X5, Canada
Toronto General Hospital
Toronto, Ontario, M5G 2N2, Canada
Weston Road Medical Clinic
Toronto, Ontario, M9N 2A7, Canada
Dr. Nigel Jagan Medicine Professional Corporation
Whitby, Ontario, L1N 2L1, Canada
Dr. Nwadiaro Medicine Professional Corp
Windsor, Ontario, N8X 1L9, Canada
Viacar Recherche Clinique Inc.
Brossard, Quebec, J4X1S4, Canada
Ecogene-21
Chicoutimi, Quebec, G7H 7K9, Canada
Q&T Research Chicoutimi
Chicoutimi, Quebec, G7H 7Y8, Canada
Viacar Recherche Clinique Inc.
Greenfield Park, Quebec, J4V2G8, Canada
CHUM Hotel-Dieu
Montreal, Quebec, H2W 1T8, Canada
Recherche Clinique Sigma, Inc.
Québec, Quebec, G1G3Z4, Canada
Iucpq
Québec, Quebec, G1V 4G5, Canada
ALPHA Recherche Clinique
Québec, Quebec, G3K 2P8, Canada
CardioVasc HR
Saint-Jean-sur-Richelieu, Quebec, j3a-1c3, Canada
ViaCar Recherche Clinique Inc
Saint-Lambert, Quebec, J4P 2H4, Canada
Viacar Recherche Clinique
Saint-Lambert, Quebec, J4P 2J2, Canada
Hopital Pierre-Le Gardeur
Terrebonne, Quebec, J6V 2H2, Canada
Instituto Sanacoop
Bayamón, 00961, Puerto Rico
San Juan Bautista School of Medicine
Caguas, 00727, Puerto Rico
Norma S. Severino-Pacheco, MD
Canovanas, 00729, Puerto Rico
Cardiometabolic Research Center
Ponce, 00717, Puerto Rico
Miguel Sosa-Padilla, MD
San Juan, 00926-2832, Puerto Rico
Yolanda Sierra Quinones, MD
Toa Baja, 00949, Puerto Rico
Related Publications (10)
Cui J, Ridker PM, Solomon DH. Blood pressure changes during methotrexate treatment: results from a randomized placebo-controlled trial among patients with cardiovascular risk. Rheumatology (Oxford). 2025 Jun 1;64(6):3917-3920. doi: 10.1093/rheumatology/keae604.
PMID: 39657237DERIVEDCui J, Chasman DI, Raychaudhuri S, Xu C, Ridker PM, Solomon DH, Karlson EW. Genetics are not likely to offer clinically useful predictions for elevated liver enzyme levels in patients using low dose methotrexate. Semin Arthritis Rheum. 2022 Aug;55:152036. doi: 10.1016/j.semarthrit.2022.152036. Epub 2022 May 28.
PMID: 35671649DERIVEDReiss AB, Teboul I, Kasselman L, Ahmed S, Carsons SE, De Leon J. Methotrexate effects on adenosine receptor expression in peripheral monocytes of persons with type 2 diabetes and cardiovascular disease. J Investig Med. 2022 Aug;70(6):1433-1437. doi: 10.1136/jim-2022-002355. Epub 2022 May 23.
PMID: 35606100DERIVEDSparks JA, Vanni KMM, Sparks MA, Xu C, Santacroce LM, Glynn RJ, Ridker PM, Solomon DH. Effect of Low-Dose Methotrexate on eGFR and Kidney Adverse Events: A Randomized Clinical Trial. J Am Soc Nephrol. 2021 Dec 1;32(12):3197-3207. doi: 10.1681/ASN.2021050598. Epub 2021 Dec 1.
PMID: 34551998DERIVEDXu C, Selhub J, Jacques P, Paynter NP, MacFadyen JG, Glynn RJ, Ridker PM, Solomon DH. Adverse effects related to methotrexate polyglutamate levels: adjudicated results from the cardiovascular inflammation reduction trial. Rheumatology (Oxford). 2021 Jun 18;60(6):2963-2968. doi: 10.1093/rheumatology/keaa650.
PMID: 34144603DERIVEDSparks JA, Dellaripa PF, Glynn RJ, Paynter NP, Xu C, Ridker PM, Solomon DH. Pulmonary Adverse Events in Patients Receiving Low-Dose Methotrexate in the Randomized, Double-Blind, Placebo-Controlled Cardiovascular Inflammation Reduction Trial. Arthritis Rheumatol. 2020 Dec;72(12):2065-2071. doi: 10.1002/art.41452. Epub 2020 Oct 7.
PMID: 32741143DERIVEDRidker PM, MacFadyen JG, Glynn RJ, Bradwin G, Hasan AA, Rifai N. Comparison of interleukin-6, C-reactive protein, and low-density lipoprotein cholesterol as biomarkers of residual risk in contemporary practice: secondary analyses from the Cardiovascular Inflammation Reduction Trial. Eur Heart J. 2020 Aug 14;41(31):2952-2961. doi: 10.1093/eurheartj/ehaa160.
PMID: 32221587DERIVEDSolomon DH, Glynn RJ, Karlson EW, Lu F, Corrigan C, Colls J, Xu C, MacFadyen J, Barbhaiya M, Berliner N, Dellaripa PF, Everett BM, Pradhan AD, Hammond SP, Murray M, Rao DA, Ritter SY, Rutherford A, Sparks JA, Stratton J, Suh DH, Tedeschi SK, Vanni KMM, Paynter NP, Ridker PM. Adverse Effects of Low-Dose Methotrexate: A Randomized Trial. Ann Intern Med. 2020 Mar 17;172(6):369-380. doi: 10.7326/M19-3369. Epub 2020 Feb 18.
PMID: 32066146DERIVEDRidker PM, Everett BM, Pradhan A, MacFadyen JG, Solomon DH, Zaharris E, Mam V, Hasan A, Rosenberg Y, Iturriaga E, Gupta M, Tsigoulis M, Verma S, Clearfield M, Libby P, Goldhaber SZ, Seagle R, Ofori C, Saklayen M, Butman S, Singh N, Le May M, Bertrand O, Johnston J, Paynter NP, Glynn RJ; CIRT Investigators. Low-Dose Methotrexate for the Prevention of Atherosclerotic Events. N Engl J Med. 2019 Feb 21;380(8):752-762. doi: 10.1056/NEJMoa1809798. Epub 2018 Nov 10.
PMID: 30415610DERIVEDEverett BM, Pradhan AD, Solomon DH, Paynter N, Macfadyen J, Zaharris E, Gupta M, Clearfield M, Libby P, Hasan AA, Glynn RJ, Ridker PM. Rationale and design of the Cardiovascular Inflammation Reduction Trial: a test of the inflammatory hypothesis of atherothrombosis. Am Heart J. 2013 Aug;166(2):199-207.e15. doi: 10.1016/j.ahj.2013.03.018. Epub 2013 May 3.
PMID: 23895801DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The trial was terminated early because the pre-specified boundary for futility was crossed for both the original and the final primary endpoints and because of the lack of evidence of a reduction in hsCRP level with methotrexate treatment.
Results Point of Contact
- Title
- Dr. Paul Ridker and Dr. Robert Glynn
- Organization
- Brigham & Women's Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Paul Ridker, MD, MPH
Brigham and Women's Hospital
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Center for Cardiovascular Disease and Prevention, Brigham and Women's Hospital
Study Record Dates
First Submitted
May 1, 2012
First Posted
May 9, 2012
Study Start
April 1, 2013
Primary Completion
April 15, 2019
Study Completion
October 30, 2019
Last Updated
July 24, 2020
Results First Posted
July 24, 2020
Record last verified: 2020-07