INfluenza Vaccine to Effectively Stop Cardio Thoracic Events and Decompensated Heart Failure
INVESTED
2 other identifiers
interventional
5,388
3 countries
190
Brief Summary
INVESTED will test the hypothesis that high dose trivalent influenza vaccine will reduce cardiopulmonary events to a greater extent than standard dose quadrivalent influenza vaccine in high-risk cardiovascular patients with a recent history of myocardial infarction or heart failure. The trial will enroll 9300 participants over one Vanguard (pilot) season and three additional influenza seasons. The primary endpoint will be a composite of all-cause mortality or cardiopulmonary hospitalization.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 heart-failure
Started Aug 2016
Typical duration for phase_4 heart-failure
190 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 25, 2016
CompletedFirst Posted
Study publicly available on registry
June 1, 2016
CompletedStudy Start
First participant enrolled
August 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2020
CompletedResults Posted
Study results publicly available
September 14, 2021
CompletedJanuary 21, 2022
December 1, 2021
3.8 years
May 25, 2016
May 24, 2021
December 22, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
All-Cause Death or Cardiopulmonary Hospitalization Within Each Vaccination Season
Number of patients with first occurrence of death or cardiopulmonary hospitalization within each vaccination season
Up to 1 year from vaccination (repeats seasonally)
Secondary Outcomes (4)
Total Cardiopulmonary Hospitalizations or Death
Up to 3 years
Cardiovascular Death or Hospitalization Within Each Vaccination Season
Up to one year from vaccination
Death or Cardiopulmonary Hospitalization Across Enrolling Seasons
Up to three years
All-Cause Mortality
Up to 3 years
Study Arms (2)
High Dose Influenza Vaccine
EXPERIMENTALHigh Dose Influenza Vaccine
Standard Dose Influenza Vaccine
ACTIVE COMPARATORStandard Dose Influenza Vaccine
Interventions
High Dose Trivalent Influenza Vaccine
Standard Dose Quadrivalent Influenza Vaccine
Eligibility Criteria
You may qualify if:
- \>= 18 years of age
- history of hospitalization for myocardial infarction within 1 year of enrollment OR a history of hospitalization for heart failure within 2 years of enrollment
- At least one of the following additional risk factors:
- Prior MI (if HF the index event above; or a second MI)
- Prior HF hospitalization (if MI the index event above; or a second HF event)
- Age ≥ 65
- Left ventricular ejection fraction (LVEF) \< 40%
- Diabetes mellitus
- Obesity (BMI ≥ 30)
- Renal impairment (eGFR ≤ 60)
- History of ischemic stroke
- History of peripheral artery disease
- Current smoking
You may not qualify if:
- Known allergy, hypersensitivity (anaphylaxis), or Guillain-Barré Syndrome within 6 weeks after influenza vaccine
- Any non-cardiac condition that in the opinion of the investigator would lead to life expectancy less than 9 months.
- Receipt of influenza vaccine during current influenza season
- Any illness requiring treatment with antibiotics or anti-inflammatory medication within the past 14 days.
- Any fever over 100 degrees Fahrenheit or 38 degrees Celsius within the past 7 days.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Brigham and Women's Hospitallead
- National Heart, Lung, and Blood Institute (NHLBI)collaborator
- University of Wisconsin, Madisoncollaborator
- University of Torontocollaborator
- Boston VA Research Institute, Inc.collaborator
- Patient-Centered Outcomes Research Institutecollaborator
- University of Minnesotacollaborator
Study Sites (190)
Birmingham VAMC
Birmingham, Alabama, 35233, United States
University of Alabama Hypertension Program
Birmingham, Alabama, 35294, United States
Heart Center Research, LLC
Huntsville, Alabama, 35801, United States
Alaska Heart & Vascular Institute
Anchorage, Alaska, 99508, United States
Banner University Medicine North
Tucson, Arizona, 85719, United States
University of Arizona- Sarver Heart Center
Tucson, Arizona, 85724, United States
CAVHS
Little Rock, Arkansas, 72205, United States
VA Loma Linda Healthcare System
Loma Linda, California, 92357, United States
Long Beach VAMC
Long Beach, California, 90822, United States
University of California Davis Medical Center
Sacramento, California, 95817, United States
VA San Diego Healthcare System
San Diego, California, 92161, United States
UCSF Medical Center
San Francisco, California, 94143, United States
VA West Haven
West Haven, Connecticut, 06516, United States
Washington DC VAMC
Washington D.C., District of Columbia, 20422, United States
Clearwater Cardiovascular Consultants
Clearwater, Florida, 33756, United States
N FL/S GA Veterans Health System
Gainesville, Florida, 32608, United States
OneFlorida CDRN
Gainesville, Florida, 32611, United States
Clearwater Cardiovascular Consultants-Largo
Largo, Florida, 33777, United States
Inpatient Research Corporation
Miami, Florida, 33014, United States
ITB Research
Miami, Florida, 33173, United States
Charlotte Heart Group Research Center
Port Charlotte, Florida, 33952, United States
Clearwater Cardiovascular Consultants-SH
Safety Harbor, Florida, 34695, United States
Bond Community Health Center, Inc.
Tallahassee, Florida, 32301, United States
Piedmont Heart Institute
Atlanta, Georgia, 30309, United States
Morehouse School of Medicine
Atlanta, Georgia, 30310, United States
Atlanta VA Health Care System
Decatur, Georgia, 30033, United States
Peidmont Fayette
Fayetteville, Georgia, 30214, United States
University of Hawaii
Honolulu, Hawaii, 96813, United States
Northwestern University
Chicago, Illinois, 60611, United States
Jesse Brown VA Medical Center
Chicago, Illinois, 60612, United States
University of Chicago Medicine
Chicago, Illinois, 60637, United States
Chicago Medical Research
Hazel Crest, Illinois, 60429, United States
Northwester Medicine Lake Forest
Lake Forest, Illinois, 60045, United States
Loyola University Medical Center
Maywood, Illinois, 60153, United States
Captain James A. Lovell Federal Health Care Center
North Chicago, Illinois, 60064, United States
UnityPoint Health Methodist
Peoria, Illinois, 61606, United States
Central DuPage Hospital
Winfield, Illinois, 60190, United States
Krannert Institute of Cardiology
Indianapolis, Indiana, 46202, United States
St. Vincent Medical Group
Indianapolis, Indiana, 46260, United States
University of Iowa
Iowa City, Iowa, 52242, United States
The University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
VA Eastern Kansas Health Care System
Leavenworth, Kansas, 66048, United States
Robley Rex VA
Louisville, Kentucky, 40206, United States
The Heart Clinic of Hamond
Hammond, Louisiana, 70403, United States
Southeast Louisiana Veterans Healthcare System
New Orleans, Louisiana, 70112, United States
Ochsner Health System- Baton Rouge
New Orleans, Louisiana, 70121, United States
ENRM VA Hospital
Bedford, Massachusetts, 01730, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Brigham and Women's Faulkner Hospital
Boston, Massachusetts, 02130, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Pentucket Medical Associates
Haverhill, Massachusetts, 01830, United States
Charles River Medical Associates
Natick, Massachusetts, 01760, United States
Boston/West Roxbury VA Hospital
West Roxbury, Massachusetts, 02132, United States
VA Boston Healthcase System
West Roxbury, Massachusetts, 02132, United States
VA Ann Harbor Healthcare System
Ann Arbor, Michigan, 48105, United States
Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
HealthPartners - Riverside Research
Minneapolis, Minnesota, 55454, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
HealthEast Medical Research Institute
Saint Paul, Minnesota, 55102, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
Kansas City VA Medical Center
Kansas City, Missouri, 64128, United States
VA St. Louis Health Care System
St Louis, Missouri, 63106, United States
St. Louis University
St Louis, Missouri, 63110, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Nebraska Heart Institute- Grand Island
Grand Island, Nebraska, 68803, United States
Darthmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Cardio Assoc. of the Del. Valley- Elmer
Elmer, New Jersey, 08318, United States
Cardio. Assoc. of the Del. Valley- Haddon Heights
Haddon Heights, New Jersey, 08035, United States
Cardio. Assoc. of the Del. Valley- Sewell
Sewell, New Jersey, 08080, United States
Lourdes Cardiology Services
Voorhees Township, New Jersey, 08043, United States
New Mexico VA Health Care System
Albuquerque, New Mexico, 87108, United States
Albany Medical College
Albany, New York, 12208, United States
New York Presbyterian Brooklyn Methodist Hospital
Brooklyn, New York, 11215, United States
New York Presbyterian Queens Bayside/Whitestone
Flushing, New York, 11355, United States
New York Presbyterian/Queens
Flushing, New York, 11355, United States
NYPQ - Cardiology Outpatient Clinic
Flushing, New York, 11355, United States
Winthrop University Hospital
Mineola, New York, 11501, United States
New York VA
New York, New York, 10010, United States
NYU Langone Medical Center
New York, New York, 10016, United States
New York Presbyterian
New York, New York, 10021, United States
Columbia University Medical Center
New York, New York, 10032, United States
University of Rochester Medical Center
Rochester, New York, 14642, United States
Stony Brook University Hospital
Stony Brook, New York, 11794, United States
Charles George VA
Asheville, North Carolina, 28805, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Duke
Durham, North Carolina, 27710, United States
Louis Stokes Cleveland VA Medical Center
Cleveland, Ohio, 44106, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Ohio State University
Columbus, Ohio, 43210, United States
Heart House Research Foundation
Springfield, Ohio, 45504, United States
Oregon Health & Science
Portland, Oregon, 97239, United States
VA Portland Health Care Systems (VAPHCS)
Portland, Oregon, 97239, United States
Temple University
Philadelphia, Pennsylvania, 19140, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
Providence VA Medical Center
Providence, Rhode Island, 02908, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
WJB Dorn VAMC
Columbia, South Carolina, 29209, United States
Palmetto Research Center, LLC
Spartanburg, South Carolina, 29302, United States
VAMC Memphis
Memphis, Tennessee, 38104, United States
Meharry Medical College
Nashville, Tennessee, 37208, United States
Tennessee Valley Healthcare Systems-Nashville
Nashville, Tennessee, 37212, United States
Vanderbilt University
Nashville, Tennessee, 37232, United States
Austin Heart- Heart Hospital
Austin, Texas, 78756, United States
Baylor Scott and White Heart and Vascular Hospital
Dallas, Texas, 75226, United States
Michael E. DeBakey VAMC, Houston
Houston, Texas, 77030, United States
Houston Heart & Vascular Associates
Kingwood, Texas, 77339, United States
Houston Methodist Research Institute-CCAT Pearland
Pearland, Texas, 77584, United States
St. David's Heath & Vascular PLLC
Round Rock, Texas, 78681, United States
South Texas Veterans Healthcare System
San Antonio, Texas, 78229, United States
STAR Clinical Trials
San Antonio, Texas, 78229, United States
Austin Heart San Marcos
San Marcos, Texas, 78666, United States
Baylor Scott and White Research Institute
Temple, Texas, 76508, United States
University of Utah
Salt Lake City, Utah, 84108, United States
George E. Wahlen Dept of VA Affairs Medical Center
Salt Lake City, Utah, 84148, United States
VA Medical Center White River Junction
White River Junction, Vermont, 05009, United States
Inova Heart and Vascular Institute
Alexandria, Virginia, 22306, United States
Carient Heart & Vascular
Manassas, Virginia, 20109, United States
Louis A Johnson VAMC
Clarksburg, West Virginia, 26301, United States
Gundersen Clinic
La Crosse, Wisconsin, 54601, United States
University of Wisconsin
Madison, Wisconsin, 53705, United States
Willam S. Middleton Memorial Veterans Hospital
Madison, Wisconsin, 53705, United States
University of Wisconsin Madison
Madison, Wisconsin, 57305, United States
Marshfield Clinic
Marshfield, Wisconsin, 54449, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Aurora Research Institute, LLC
Milwaukee, Wisconsin, 53233, United States
Celement J. Zablocki VA Medical Center
Milwaukee, Wisconsin, 53295, United States
TotalCardiology
Calgary, Alberta, T2E 7C5, Canada
University of Calgary
Calgary, Alberta, T2N4Z6, Canada
CK Hui Heart Centre, Royal Alexandra Hospital
Edmonton, Alberta, T5H3V9, Canada
Dr. MPJ Senaratne Professional Corporation
Edmonton, Alberta, T6K4C1, Canada
Northwest Echocardiolography
Grande Prairie, Alberta, T8V 2E7, Canada
The CARe Clinic (Central Alberta Research)
Red Deer, Alberta, T4N6V7, Canada
University of Alberta Hospital- Mazankoski Heart Institute
Edmonton, British Columbia, T6G2B7, Canada
Kelowna General Hospital
Kelowna, British Columbia, V1Y1T2, Canada
SMH Cardiology Clinical
Surrey, British Columbia, V3V 0C6, Canada
Manna Research Inc. (Vancouver)
Vancouver, British Columbia, V5X0C4, Canada
Vancouver General Hospital - Gordon Leslie Diamond Centre
Vancouver, British Columbia, V5Z1M9, Canada
St. Paul's Hospital
Vancouver, British Columbia, V6Z1Y6, Canada
Victoria Heart Institute Foundation
Victoria, British Columbia, V8R4R2, Canada
St. Boniface Hospital/University of Manitoba
Winnipeg, Manitoba, R2H2A6, Canada
University of Sherbrooke
Dieppe, New Brunswick, Canada
G.A Research Associates Ltd.
Moncton, New Brunswick, E1G 1A7, Canada
QEII Health Sciences
Halifax, Nova Scotia, B3H2Y9, Canada
Brampton Research Assocaites
Brampton, Ontario, L6Z 4N5, Canada
Manna Research Inc. (Burlington North)
Burlington, Ontario, L7M 4Y1, Canada
Manna Research Inc. (Burlington South)
Burlington, Ontario, L7R 1A4, Canada
Cambridge Cardiac Care Center
Cambridge, Ontario, N1R 6V6, Canada
Vizel Cardiac Research
Cambridge, Ontario, N1R 7R1, Canada
Dr. Alan David Bell
Downsview, Ontario, M3M 3E5, Canada
Health Sciences North Research Institute
Greater Sudbury, Ontario, P3E 5J1, Canada
Dr. D. Shukla Professional Medicine Corporation
Greater Sudbury, Ontario, P3E 5M4, Canada
Dr. R. Labonte Professional Medicine Corporation
Greater Sudbury, Ontario, P3E 5M4, Canada
Hamilton Health Sciences General Hospital/ McMaste
Hamilton, Ontario, L8L 2X2, Canada
Queen's University CardioPulmonary Unit
Kingston, Ontario, K7L 3N6, Canada
St. Joseph's Health Care
London, Ontario, N6A 4V2, Canada
Dixie Medical Group
Mississauga, Ontario, L4W 0C2, Canada
Apple Hills Medical Associates
Mississauga, Ontario, L4Y 2N8, Canada
PACE
Newmarket, Ontario, L3Y 2P6, Canada
North York General Hospital
North York, Ontario, M2K 1E1, Canada
Sewa Ram Singal Med Prof Corporation
North York, Ontario, M3N 1N1, Canada
Heart Care Research
Oshawa, Ontario, L1J 2J9, Canada
Dr. James Cha
Oshawa, Ontario, L1J 2K1, Canada
Montfort Hospital and Ottawa Cardiovascular Centre
Ottawa, Ontario, K1K 0T2, Canada
University of Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7, Canada
Heart Function Clinic Queensway Carleton
Ottawa, Ontario, K2H 8P4, Canada
Kawartha Cardiology
Peterborough, Ontario, K9J0B2, Canada
St. Catherines Hospital
Saint Catherines, Ontario, L2M 5V4, Canada
Scarborough General Hospital
Scarborough Village, Ontario, M1P 2T7, Canada
Manna Research (Stoney Creek)
Stoney Creek, Ontario, L8J 3W2, Canada
Thunder Bay Regional Health Sciences Center
Thunder Bay, Ontario, P7B 6V4, 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
Women's College Hospital
Toronto, Ontario, M5S 1B2, Canada
University of Toronto
Toronto, Ontario, Canada
iHealthCentre
Vaughan, Ontario, L4H 0P6, Canada
CISSS de Laval, Hopital Cite de la Sante
Laval, Quebec, H7M 3L9, Canada
Montreal Heart Institute
Montreal, Quebec, H1T 1C8, Canada
McGill University Health Centre
Montreal, Quebec, H3G 1A4, Canada
Jewish General Hospital
Montreal, Quebec, H3T 1E2, Canada
CIUSSS NÎM Hopital du Sacre-Coeur de Montreal
Montreal, Quebec, H4J 1C5, Canada
Manna Research Inc. (Montreal)
Montreal, Quebec, H9R 4S3, Canada
IUCPQ
Québec, Quebec, G1V 4G5, Canada
Centre hospitalier régional de Lanaudière
Saint-Charles-Borromée, Quebec, J6E 6J2, Canada
CISSSI- Hopital Pierre-Le Gardeur
Terrebonne, Quebec, J6V 2H2, Canada
Centre Hospitalier de Regional Trois-Rivieres
Trois-Rivières, Quebec, G8Z 3R9, Canada
Prairie Vascular Research Inc.
Regina, Saskatchewan, 54P 0W5, Canada
VA Caribbean Healthcare System
San Juan, 00921, Puerto Rico
Related Publications (14)
Vardeny O, Sweitzer NK, Detry MA, Moran JM, Johnson MR, Hayney MS. Decreased immune responses to influenza vaccination in patients with heart failure. J Card Fail. 2009 May;15(4):368-73. doi: 10.1016/j.cardfail.2008.11.009. Epub 2008 Dec 18.
PMID: 19398087BACKGROUNDVardeny O, Moran JJ, Sweitzer NK, Johnson MR, Hayney MS. Decreased T-cell responses to influenza vaccination in patients with heart failure. Pharmacotherapy. 2010 Jan;30(1):10-6. doi: 10.1592/phco.30.1.10.
PMID: 20030468BACKGROUNDVan Ermen A, Hermanson MP, Moran JM, Sweitzer NK, Johnson MR, Vardeny O. Double dose vs. standard dose influenza vaccination in patients with heart failure: a pilot study. Eur J Heart Fail. 2013 May;15(5):560-4. doi: 10.1093/eurjhf/hfs207. Epub 2013 Jan 4.
PMID: 23291729BACKGROUNDAlbrecht CM, Sweitzer NK, Johnson MR, Vardeny O. Lack of persistence of influenza vaccine antibody titers in patients with heart failure. J Card Fail. 2014 Feb;20(2):105-9. doi: 10.1016/j.cardfail.2013.12.008. Epub 2013 Dec 19.
PMID: 24361852BACKGROUNDUdell JA, Farkouh ME, Solomon SD, Vardeny O. Does influenza vaccination influence cardiovascular complications? Expert Rev Cardiovasc Ther. 2015 Jun;13(6):593-6. doi: 10.1586/14779072.2015.1044439. Epub 2015 May 14.
PMID: 25971953BACKGROUNDVardeny O, Claggett B, Udell JA, Packer M, Zile M, Rouleau J, Swedberg K, Desai AS, Lefkowitz M, Shi V, McMurray JJV, Solomon SD; PARADIGM-HF Investigators. Influenza Vaccination in Patients With Chronic Heart Failure: The PARADIGM-HF Trial. JACC Heart Fail. 2016 Feb;4(2):152-158. doi: 10.1016/j.jchf.2015.10.012. Epub 2015 Dec 30.
PMID: 26746371BACKGROUNDUdell JA, Zawi R, Bhatt DL, Keshtkar-Jahromi M, Gaughran F, Phrommintikul A, Ciszewski A, Vakili H, Hoffman EB, Farkouh ME, Cannon CP. Association between influenza vaccination and cardiovascular outcomes in high-risk patients: a meta-analysis. JAMA. 2013 Oct 23;310(16):1711-20. doi: 10.1001/jama.2013.279206.
PMID: 24150467BACKGROUNDVardeny O, Udell JA, Joseph J, Farkouh ME, Hernandez AF, McGeer AJ, Talbot HK, Bhatt DL, Cannon CP, Goodman SG, Anand I, DeMets DL, Temte J, Wittes J, Nichol K, Yancy CW, Gaziano JM, Cooper LS, Kim K, Solomon SD. High-dose influenza vaccine to reduce clinical outcomes in high-risk cardiovascular patients: Rationale and design of the INVESTED trial. Am Heart J. 2018 Aug;202:97-103. doi: 10.1016/j.ahj.2018.05.007. Epub 2018 May 23.
PMID: 29909156BACKGROUNDVardeny O, Kim K, Udell JA, Joseph J, Desai AS, Farkouh ME, Hegde SM, Hernandez AF, McGeer A, Talbot HK, Anand I, Bhatt DL, Cannon CP, DeMets D, Gaziano JM, Goodman SG, Nichol K, Tattersall MC, Temte JL, Wittes J, Yancy C, Claggett B, Chen Y, Mao L, Havighurst TC, Cooper LS, Solomon SD; INVESTED Committees and Investigators. Effect of High-Dose Trivalent vs Standard-Dose Quadrivalent Influenza Vaccine on Mortality or Cardiopulmonary Hospitalization in Patients With High-risk Cardiovascular Disease: A Randomized Clinical Trial. JAMA. 2021 Jan 5;325(1):39-49. doi: 10.1001/jama.2020.23649.
PMID: 33275134RESULTLassen MCH, Howell N, Claggett BL, Biering-Sorensen T, Vardeny O, Solomon SD, Udell J, Joseph J, Hegde SM. Educational Attainment Level and Risk of Mortality and Cardiopulmonary Outcomes in High-Risk Patients With Cardiovascular Disease: The INVESTED Trial. J Am Heart Assoc. 2025 Jul;14(13):e040221. doi: 10.1161/JAHA.124.040221. Epub 2025 Jun 18.
PMID: 40530474DERIVEDPeikert A, Claggett BL, Udell JA, Joseph J, Hegde SM, Kim K, Mao L, Wang T, Havighurst TC, Farkouh ME, Bhatt DL, Tattersall MC, Cooper LS, Solomon SD, Vardeny O. Influenza Vaccine Immune Response in Patients With High-Risk Cardiovascular Disease: A Secondary Analysis of the INVESTED Randomized Clinical Trial. JAMA Cardiol. 2024 Jun 1;9(6):574-581. doi: 10.1001/jamacardio.2024.0468.
PMID: 38583091DERIVEDHegde SM, Claggett BL, Udell JA, Kim K, Joseph J, Farkouh ME, Peikert A, Bhatt AS, Tattersall MC, Bhatt DL, Cooper LS, Solomon SD, Vardeny O. Temporal Association Among Influenza-Like Illness, Cardiovascular Events, and Vaccine Dose in Patients With High-Risk Cardiovascular Disease: Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2023 Sep 5;6(9):e2331284. doi: 10.1001/jamanetworkopen.2023.31284.
PMID: 37707817DERIVEDWang T, Mao L. Stratified proportional win-fractions regression analysis. Stat Med. 2022 Nov 20;41(26):5305-5318. doi: 10.1002/sim.9570. Epub 2022 Sep 14.
PMID: 36104953DERIVEDVardeny O, Hernandez AF, Cohen LW, Franklin A, Baqai M, Palmer S, Bierer BE, Cobb N. Transitioning to the National Institutes of Health single institutional review board model: Piloting the use of the Streamlined, Multi-site, Accelerated Resources for Trials IRB Reliance. Clin Trials. 2019 Jun;16(3):290-296. doi: 10.1177/1740774519832911. Epub 2019 Mar 13.
PMID: 30866676DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Scott Solomon
- Organization
- Brigham and Women's Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Orly Vardeny, PharmD, MS
University of Minnesota
- PRINCIPAL INVESTIGATOR
Scott D Solomon, MD
Brigham and Women's Hospital
- PRINCIPAL INVESTIGATOR
KyungMann Kim, PhD
University of Wisconsin, Madison
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Medicine
Study Record Dates
First Submitted
May 25, 2016
First Posted
June 1, 2016
Study Start
August 1, 2016
Primary Completion
May 31, 2020
Study Completion
May 31, 2020
Last Updated
January 21, 2022
Results First Posted
September 14, 2021
Record last verified: 2021-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- Data will be available as per NIH guidelines on December 4, 2022 (2 years from the primary study publication date).
- Access Criteria
- Data will be available to all qualified researchers based on the NIH BIOLINCC criteria.
Data will be shared according to NIH data sharing rules