NCT02981407

Brief Summary

The purpose of this study is to compare two red blood cell transfusion strategies (liberal and restrictive) for patients who have had an acute myocardial infarction and are anemic.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,506

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Apr 2017

Longer than P75 for phase_3

Geographic Reach
6 countries

133 active sites

Status
completed

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

December 1, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 5, 2016

Completed
5 months until next milestone

Study Start

First participant enrolled

April 25, 2017

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2023

Completed
7 months until next milestone

Results Posted

Study results publicly available

May 9, 2024

Completed
Last Updated

May 9, 2024

Status Verified

April 1, 2024

Enrollment Period

6.1 years

First QC Date

December 1, 2016

Results QC Date

March 19, 2024

Last Update Submit

April 16, 2024

Conditions

Keywords

Red Blood Cell TransfusionAnemiaHeart DiseaseCardiovascular Disease

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With All-cause Mortality or Nonfatal Myocardial Reinfarction

    Within 30 days of randomization

Secondary Outcomes (3)

  • All-cause Mortality

    Within 30 days of randomization

  • Myocardial Reinfarction

    Within 30 days of randomization

  • Composite of All-cause Mortality, Nonfatal Myocardial Reinfarction, Ischemia Driven Unscheduled Coronary Revascularization, or Readmission to the Hospital for Ischemic Cardiac Diagnosis

    Within 30 days of randomization

Other Outcomes (15)

  • Composite of All-cause Mortality,Nonfatal Myocardial Reinfarction, or Unstable Angina

    Within 30 days of randomization

  • Ischemia Driven Unscheduled Coronary Revascularization

    Within 30 days of randomization

  • Unscheduled Readmission to Hospital for Ischemic Cardiac Diagnosis

    Within 30 days of randomization

  • +12 more other outcomes

Study Arms (2)

Liberal Transfusion Strategy

ACTIVE COMPARATOR

Red blood cell transfusion - One unit of packed red cells is transfused following randomization followed by enough red blood cell units to raise the hemoglobin concentration above 10 g/dL any time the hemoglobin concentration is detected to be below 10g/dL during the hospitalization for up to 30 days.

Biological: Red Blood Cell Transfusion

Restrictive Transfusion Strategy

ACTIVE COMPARATOR

Permitted to receive a red blood cell transfusion if the blood count is below 8 g/dL and the physician believes it is in the patient's best interest. A transfusion will be strongly recommended if the blood count drops to less than 7 g/dL. If the patient has symptoms of angina (e.g., chest discomfort described as pressure or heaviness) that do not go away with medication, a blood transfusion will be ordered regardless of the blood count.

Biological: Red Blood Cell Transfusion

Interventions

Transfusion of packed red blood cell units

Liberal Transfusion StrategyRestrictive Transfusion Strategy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older
  • Either ST segment elevation myocardial infarction or Non ST segment elevation myocardial infarction consistent with the 3rd Universal Definition of Myocardial Infarction criteria that occurs on admission or during the index hospitalization
  • Hemoglobin concentration less than 10 g/dL at the time of random allocation
  • Patient physician believes that both of the transfusion strategies are consistent with good medical care for the patient

You may not qualify if:

  • Uncontrolled acute bleeding at the time of randomization defined as the need for uncrossed or non-type specific blood
  • Decline blood transfusion
  • Scheduled for cardiac surgery during the current admission
  • Receiving only palliative treatment
  • Known that follow-up will not be possible at 30 days
  • Previously participated in MINT
  • Currently enrolled in a competing study that interferes with the intervention or follow-up of MINT or enrolled in a competing study that has not been approved by the local Institutional Review Board
  • Patient physician does not believe the patient is an appropriate candidate for the trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (133)

Central Arkansas Veterans Healthcare System

Little Rock, Arkansas, 72205, United States

Location

University of Arkansas Medical Sciences (UAMS) Hospital

Little Rock, Arkansas, 72205, United States

Location

VAGLAHS

Los Angeles, California, 90073, United States

Location

Danbury Hospital

Danbury, Connecticut, 06810, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

Alexian Brothers Medical Center

Elk Grove Village, Illinois, 60007, United States

Location

AMITA Health

Hinsdale, Illinois, 60521, United States

Location

Saint Luke's Mid America Heart

Kansas City, Kansas, 64111, United States

Location

University of Louisville

Louisville, Kentucky, 40202, United States

Location

Tulane University School of Medicine

New Orleans, Louisiana, 70112, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 01930, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 15261, United States

Location

Lahey Hospital

Burlington, Massachusetts, 01805, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

St. Joseph Mercy Health System

Ypsilanti, Michigan, 48197, United States

Location

Essentia Health

Duluth, Minnesota, 55805, United States

Location

University of Minnesota Medical Center Fairview

Minneapolis, Minnesota, 55105, United States

Location

Minneapolis Heart Institute (Foundation)

Minneapolis, Minnesota, 55407-1130, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Memorial Hospital at Gulfport

Gulfport, Mississippi, 39502, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Copper University Hospital

Camden, New Jersey, 08103, United States

Location

Hackensacjk University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Jersey Shore University Medical

Neptune City, New Jersey, 08759, United States

Location

Robert Wood Johnson University Hospital

New Brunswick, New Jersey, 08903, United States

Location

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

Albany Medical College

Albany, New York, 12208, United States

Location

Southside Hospital

Bay Shore, New York, 11706, United States

Location

NYP Brooklyn Methodist

Brooklyn, New York, 11215, United States

Location

New York Presbyterian/Queens

Flushing, New York, 11355, United States

Location

Westchester Medical Center

Hawthorne, New York, 10532, United States

Location

North Shore University Hospital

Manhasset, New York, 11030, United States

Location

Northern Westchester Hospital

Mount Kisco, New York, 10549, United States

Location

NYU Langone Medical Center, Bellevue Hospital

New York, New York, 10016, United States

Location

Lenox Hilll Hospital

New York, New York, 10075, United States

Location

Rochester General Hospital

Rochester, New York, 14450, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

Northwell Staten Island Hopsital

Staten Island, New York, 10305, United States

Location

Stony Brook Medicine

Stony Brook, New York, 11794-8167, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599-7097, United States

Location

Durham Va

Durham, North Carolina, 27705, United States

Location

WakeMed Health and Hospital

Raleigh, North Carolina, 27610, United States

Location

Aultman Hospital

Canton, Ohio, 44710, United States

Location

University of Toledo Medical Center

Toledo, Ohio, 43614, United States

Location

Lancaster General Hospital

Lancaster, Pennsylvania, 17602, United States

Location

PENN Presbyterian Medical Cente

Philadelphia, Pennsylvania, 19104, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15261, United States

Location

Lankenau Medical Center

Wynnewood, Pennsylvania, 19096, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

The Miriam Hospital

Providence, Rhode Island, 02906, United States

Location

Greenville Health System

Greenville, South Carolina, 29605, United States

Location

The Memphis VAMC

Memphis, Tennessee, 38104, United States

Location

Baylor St Luke's Medical Center

Houston, Texas, 77030, United States

Location

University of Vermont Medical Center

Burlington, Vermont, 05401, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Medical College of Wisconsin - Froedtert Hospital

Milwaukee, Wisconsin, 53226, United States

Location

Flinders Medical Centre

Bedford Park, Australia

Location

Concord Repatriation General Hospital

Concord, Australia

Location

Gosford Hospital

Gosford, Australia

Location

Royal Perth Hospital

Perth, Australia

Location

Instituto de Ensino e Pesquisa do Hospital da Bahia

Pituba, Salvador, 41810, Brazil

Location

Hospital de Base de Rio Preto

São José do Rio Preto, São Paulo, 15080-310, Brazil

Location

Hospital Felício Rocho

Belo Horizonte, Brazil

Location

Instituto Orizonti

Belo Horizonte, Brazil

Location

Instituto de Ensino e Pesquisa do Hospital do Coração do Brasil

Brasília, Brazil

Location

Hospital Vera Cruz

Campinas, Brazil

Location

Santa Casa de Marília

Cascata, 17515-900, Brazil

Location

Sociedade Hospitalar Angelina Caron

Centro, 83430-000, Brazil

Location

Hospital Maternidade e Pronto Socorro Santa Lúcia

Poços de Caldas, Brazil

Location

Instituto de Cardiologia do RS

Porto Alegre, Brazil

Location

Hospital Agamenon Magalhães

Recife, Brazil

Location

Pronto Socorro Cardiológico de Pernambuco Prof. Luiz Tavares- PROCAPE

Recife, Brazil

Location

Hospital Cárdio Pulmonar

Salvador, Brazil

Location

Hospital Universitário Professor Edgard Santos

Salvador, Brazil

Location

Hospital de Base de Rio Preto

São José do Rio Preto, Brazil

Location

Hospital São Paulo

São Paulo, 04024-002, Brazil

Location

Hospital de Clínicas da UFTM

Uberaba, Brazil

Location

Hospital das Clinicas da UFU

Uberlândia, Brazil

Location

Foothills Medical Centre

Calgary, Alberta, Canada

Location

Grey Nuns Community Hospital

Edmonton, Alberta, Canada

Location

Royal Alexandra Hospital

Edmonton, Alberta, Canada

Location

University of Alberta Hospital

Edmonton, Alberta, Canada

Location

Royal Columbian Hospital

New Westminster, British Columbia, Canada

Location

Surrey Memorial Hospital

Surrey, British Columbia, Canada

Location

Vancouver General Hospital

Vancouver, British Columbia, Canada

Location

St. Boniface General Hospital

Winnipeg, Manitoba, Canada

Location

QE II Health Sciences Center

Halifax, Nova Scotia, Canada

Location

Hamilton Health Sciences

Hamilton, Ontario, Canada

Location

Hamilton St. Joseph's Health

Hamilton, Ontario, Canada

Location

St. Joseph's Health Centre

Hamilton, Ontario, Canada

Location

University Hospital - LHSC

London, Ontario, Canada

Location

Victoria Hospital - LHSC

London, Ontario, Canada

Location

St. Michael's Hospital

Toronto, Ontario, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Location

Victoria Heart Institute

Victoria, Ontario, Canada

Location

Hôpital Charles Lemoyne

Greenfield Park, Quebec, Canada

Location

Hotel-Dieu de Levis

Lévis, Quebec, Canada

Location

Centre Hosp. Universitaire de Montréal

Montreal, Quebec, Canada

Location

Jewish General Hospital

Montreal, Quebec, Canada

Location

Montreal General Hospital

Montreal, Quebec, Canada

Location

Royal Victoria Hospital

Montreal, Quebec, Canada

Location

Quebec Heart and Lung Institute

Québec, Quebec, Canada

Location

Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, Canada

Location

General Hospital Trois-Rivièrs

Trois-Rivières, Quebec, Canada

Location

Regina General Hospital

Regina, Saskatchewan, Canada

Location

CHRU Tours -Hôpital Trousseau

Chambray-lès-Tours, France

Location

CH Chartres - Chartres

Chartres, France

Location

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, France

Location

CHU le Bocage - Dijon

Dijon, 21079, France

Location

La Tronche Hôpital Michallon

La Tronche, France

Location

Centre Hospitalier Universitaire de Lille

Lille, 59000, France

Location

CHU Arnaud de Villeneuve - Montpellier

Montpellier, France

Location

CHU Nancy

Nancy, France

Location

Hôpital Pasteur

Nice, 06000, France

Location

Hôpital Universitaire Carémeau (CHU Carémeau)

Nîmes, 30029, France

Location

Hôpital La Pitié Salpétrière

Paris, 75013, France

Location

Hôpital Européen Georges-Pompidou

Paris, 75015, France

Location

Hôpital BICHAT- APHP

Paris, 75018, France

Location

Hôpital Lariboisière

Paris, France

Location

Hôpital Haut Lévêque

Pessac, 33604, France

Location

CHU Poitiers - Poitiers

Poitiers, France

Location

Hôpital Charles Nicolle- Rouen

Rouen, France

Location

Hôpital Rangueil

Toulouse, 31400, France

Location

Auckland City Hospital

Auckland, New Zealand

Location

Christchurch Hospital

Christchurch, New Zealand

Location

Gisborne Hospital

Gisborne, New Zealand

Location

Nelson Hospital

Nelson, New Zealand

Location

Taranaki Hospital

New Plymouth, New Zealand

Location

Whangarei Hospital

Whangarei, New Zealand

Location

Related Publications (15)

  • Carson JL, Brooks MM, Abbott JD, Chaitman B, Kelsey SF, Triulzi DJ, Srinivas V, Menegus MA, Marroquin OC, Rao SV, Noveck H, Passano E, Hardison RM, Smitherman T, Vagaonescu T, Wimmer NJ, Williams DO. Liberal versus restrictive transfusion thresholds for patients with symptomatic coronary artery disease. Am Heart J. 2013 Jun;165(6):964-971.e1. doi: 10.1016/j.ahj.2013.03.001. Epub 2013 Apr 8.

    PMID: 23708168BACKGROUND
  • Carson JL, Guyatt G, Heddle NM, Grossman BJ, Cohn CS, Fung MK, Gernsheimer T, Holcomb JB, Kaplan LJ, Katz LM, Peterson N, Ramsey G, Rao SV, Roback JD, Shander A, Tobian AA. Clinical Practice Guidelines From the AABB: Red Blood Cell Transfusion Thresholds and Storage. JAMA. 2016 Nov 15;316(19):2025-2035. doi: 10.1001/jama.2016.9185.

    PMID: 27732721BACKGROUND
  • Carson JL, Brooks MM, Chaitman BR, Alexander JH, Goodman SG, Bertolet M, Abbott JD, Cooper HA, Rao SV, Triulzi DJ, Fergusson DA, Kostis WJ, Noveck H, Simon T, Steg PG, DeFilippis AP, Goldsweig AM, Lopes RD, White H, Alsweiler C, Morton E, Hebert PC; MINT Investigators. Rationale and design for the myocardial ischemia and transfusion (MINT) randomized clinical trial. Am Heart J. 2023 Mar;257:120-129. doi: 10.1016/j.ahj.2022.11.015. Epub 2022 Nov 20.

    PMID: 36417955BACKGROUND
  • Carson JL, Brooks MM, Hebert PC, Goodman SG, Bertolet M, Glynn SA, Chaitman BR, Simon T, Lopes RD, Goldsweig AM, DeFilippis AP, Abbott JD, Potter BJ, Carrier FM, Rao SV, Cooper HA, Ghafghazi S, Fergusson DA, Kostis WJ, Noveck H, Kim S, Tessalee M, Ducrocq G, de Barros E Silva PGM, Triulzi DJ, Alsweiler C, Menegus MA, Neary JD, Uhl L, Strom JB, Fordyce CB, Ferrari E, Silvain J, Wood FO, Daneault B, Polonsky TS, Senaratne M, Puymirat E, Bouleti C, Lattuca B, White HD, Kelsey SF, Steg PG, Alexander JH; MINT Investigators. Restrictive or Liberal Transfusion Strategy in Myocardial Infarction and Anemia. N Engl J Med. 2023 Dec 28;389(26):2446-2456. doi: 10.1056/NEJMoa2307983. Epub 2023 Nov 11.

    PMID: 37952133BACKGROUND
  • Carson JL, Stanworth SJ, Dennis JA, Fergusson DA, Pagano MB, Roubinian NH, Turgeon AF, Valentine S, Trivella M, Doree C, Hebert PC. Transfusion thresholds and other strategies for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2025 Oct 20;10(10):CD002042. doi: 10.1002/14651858.CD002042.pub6.

  • Prochaska MT, Portela GT, Brooks MM, Fergusson DA, Hebert PC, Polonsky TS, Caixeta A, Cooper HA, Crozier I, Daneault B, Kim S, Bainey KR, de Barros E Silva P, Goldfarb M, Gupta R, Rao SV, Fonteles Ritt LE, Simon T, Carson JL. Transfusion Strategy Effect on Quality of Life in Patients With Myocardial Infarction and Anemia: A Secondary Analysis of the MINT Randomized Clinical Trial. JAMA Intern Med. 2025 Aug 1;185(8):947-954. doi: 10.1001/jamainternmed.2025.0654.

  • Rao SV, Brooks MM, D'Agostino HEA, Steg PG, Simon T, Aronow HD, Goldsweig AM, Malik S, Alsweiler C, Ho KKL, Dehghani P, Caixeta A, Quraishi AR, Robinson S, Traverse JH, Siddiqi O, Fergusson DA, Potter BJ, Schulman-Marcus J, Keating FK, Carson JL; MINT Trial Investigators. Effect of Red Blood Cell Transfusion Strategy on Clinical Outcomes Among Patients With Acute Myocardial Infarction Undergoing Revascularization: A Prespecified Analysis of the MINT Trial. Circ Cardiovasc Interv. 2025 May;18(5):e015249. doi: 10.1161/CIRCINTERVENTIONS.125.015249. Epub 2025 Mar 30.

  • Goldsweig AM, Kostis WJ, Herbert BM, Bouleti C, Potter BJ, Strom JB, Benatar J, Huynh T, Vallurupalli S, Figueiredo EL, Abbott JD, Cooper HA, DeFilippis AP, Fergusson DA, Goodman SG, Hebert PC, Lopes RD, Rao SV, Simon T, Carson JL, Brooks MM, Alexander JH; MINT Investigators. Blood Transfusion in Patients With Acute Myocardial Infarction, Anemia, and Heart Failure: Lessons From MINT. Circ Heart Fail. 2025 Apr;18(4):e012495. doi: 10.1161/CIRCHEARTFAILURE.124.012495. Epub 2025 Mar 26.

  • Portela GT, Ducrocq G, Bertolet M, Alexander JH, Goodman SG, Glynn S, Strom JB, Swanson SA, Lemesle G, Rao SV, Tessalee M, Polonsky TS, Goldfarb M, Traverse JH, Uhl L, Herbert BM, Silvain J, Carson JL, Brooks MM; MINT Trial Investigators. Individualized transfusion decisions to minimize adverse cardiovascular outcomes in patients with acute myocardial infarction and anemia. Am Heart J. 2025 Apr;282:146-155. doi: 10.1016/j.ahj.2025.01.009. Epub 2025 Jan 17.

  • Strom JB, Herbert BM, Bertolet M, Brooks MM, Malik SA, Lemesle G, Madan M, Steg PG, Hebert PC, Traverse JH, White HD, Alsweiler C, Gupta R, Ritt LEF, Menegus MA, Alexander JH, Lopes RD, Chaitman BR, Carson JL; MINT Trial Investigators. Restrictive or Liberal Blood Transfusion in Patients with Myocardial Infarction and CKD. J Am Soc Nephrol. 2025 Jun 1;36(6):1116-1125. doi: 10.1681/ASN.0000000595. Epub 2025 Jan 9.

  • Carrier FM, Cooper HA, Portela GT, Bertolet M, Lemesle G, Prochaska M, Kim S, Alexander JH, Crozier I, Ducrocq G, Quadros AS, Bagai A, Dracoulakis M, Madan M, Brooks MM, Carson JL, Hebert PC; MINT Investigators. Anemia Acuity Effect on Transfusion Strategies in Acute Myocardial Infarction: A Secondary Analysis of the MINT Trial. JAMA Netw Open. 2024 Nov 4;7(11):e2442361. doi: 10.1001/jamanetworkopen.2024.42361.

  • Portela GT, Carson JL, Swanson SA, Alexander JH, Hebert PC, Goodman SG, Steg PG, Bertolet M, Strom JB, Fergusson DA, Simon T, White HD, Cooper HA, Abbott JD, Rao SV, Chaitman BR, Fordyce CB, Lopes RD, Daneault B, Brooks MM; MINT Investigators. Effect of Four Hemoglobin Transfusion Threshold Strategies in Patients With Acute Myocardial Infarction and Anemia : A Target Trial Emulation Using MINT Trial Data. Ann Intern Med. 2024 Nov;177(11):1489-1498. doi: 10.7326/M24-0571. Epub 2024 Oct 1.

  • Simon T, Herbert BM, Brooks MM, Goodman SG, Alexander JH, Steg PG, Lopes RD, Ghafghazi S, Bouleti C, Cooper HA, McCamant EL, Bainey KR, Aronow HD, Abbott JD, Alsweiler C, Bertolet M, Fergusson DA, Goldsweig AM, Hebert PC, Carson JL; MINT Trial Investigators. Restrictive or Liberal Transfusion Strategy in Patients With Acute Myocardial Infarction and Anemia: 6-Month Mortality in the MINT Trial. Circulation. 2024 Sep 24;150(13):1064-1066. doi: 10.1161/CIRCULATIONAHA.124.069917. Epub 2024 Sep 2. No abstract available.

  • DeFilippis AP, Abbott JD, Herbert BM, Bertolet MH, Chaitman BR, White HD, Goldsweig AM, Polonsky TS, Gupta R, Alsweiler C, Silvain J, de Barros E Silva PGM, Hillis GS, Daneault B, Tessalee M, Menegus MA, Rao SV, Lopes RD, Hebert PC, Alexander JH, Brooks MM, Carson JL, Goodman SG; MINT Investigators. Restrictive Versus Liberal Transfusion in Patients With Type 1 or Type 2 Myocardial Infarction: A Prespecified Analysis of the MINT Trial. Circulation. 2024 Dec 3;150(23):1826-1836. doi: 10.1161/CIRCULATIONAHA.124.071208. Epub 2024 Aug 29.

  • Carson JL, Stanworth SJ, Dennis JA, Trivella M, Roubinian N, Fergusson DA, Triulzi D, Doree C, Hebert PC. Transfusion thresholds for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2021 Dec 21;12(12):CD002042. doi: 10.1002/14651858.CD002042.pub5.

MeSH Terms

Conditions

Myocardial InfarctionAnemiaHeart DiseasesCardiovascular Diseases

Interventions

Erythrocyte Transfusion

Condition Hierarchy (Ancestors)

Myocardial IschemiaVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Blood Component TransfusionBlood TransfusionBiological TherapyTherapeutics

Results Point of Contact

Title
Dr. Jeffrey Carson
Organization
Rutgers Robert Wood Johnson Medical School

Study Officials

  • Jeffrey L Carson, MD

    Rutgers Robert Wood Johnson Medical School

    PRINCIPAL INVESTIGATOR
  • Maria Mori Brooks, PhD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 1, 2016

First Posted

December 5, 2016

Study Start

April 25, 2017

Primary Completion

May 31, 2023

Study Completion

October 20, 2023

Last Updated

May 9, 2024

Results First Posted

May 9, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will share

Limited access data (i.e., records without personal identifiers) will be prepared by the Data Coordinating Center (DCC) and sent to the NHLBI Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC) within 3 years after the end of the final patient follow-up or 2 years after the main paper of the trial has been published, whichever comes first. The Trial data set will include baseline patient characteristics, follow-up status, and clinical outcome data. The data will be released to requesting institutions and investigators in accordance with BioLINCC policy.

Locations