Phase 3
N=3,506
Myocardial Ischemia and Transfusion
Myocardial Infarction · Anemia
Bottom Line
View on ClinicalTrials.gov: NCT02981407 ↗Enrolled (actual)
3,506
Serious AEs
40.6%
Results posted
May 2024
Primary outcome: Primary: Number of Participants With All-cause Mortality or Nonfatal Myocardial Reinfarction — 255; 295 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Red Blood Cell Transfusion (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Rutgers, The State University of New Jersey
- Primary completion
- May 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With All-cause Mortality or Nonfatal Myocardial Reinfarction |
255; 295 | — |
| SECONDARY All-cause Mortality |
— | — |
| SECONDARY Myocardial Reinfarction |
126; 149 | — |
| SECONDARY Composite of All-cause Mortality, Nonfatal Myocardial Reinfarction, Ischemia Driven Unscheduled Coronary Revascularization, or Readmission to the Hospital for Ischemic Cardiac Diagnosis |
305; 342 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 18 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT02981407). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.