The study population will consist of up to 452 male and female subjects with anterior STEMI and occluded proximal or mid LAD with TIMI 0/1 flow with indication for primary PCI. MedDRA version: 9.1 Level: LLT Classification code 10000891 Term: Acute myocardial infarction MedDRA version: 9.1 Level: LLT Classification code 10000904 Term: Acute myocardial infarction, of other anterior wall
Conditions
Interventions
Trade Name: REOPRO
Product Name: ReoPro
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: ABCIXIMAB
CAS Number: 143653536
Current Sponsor code: Eli Lilly
Other descriptive name: REOPRO
C
Sponsors
Atrium Medical Corporation
Cardiovascular Research Foundation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The subject must be = 18 years of age; 2. Subject is experiencing clinical symptoms consistent with AMI (e.g., chest pain, arm pain, etc.,) >30 minutes duration and unresponsive to nitroglycerin; 3. Anterior MI with ECG showing at least 1 mm of ST-segment elevation in 2 or more contiguous leads in V1-V4, or new (or presumably new) left bundle branch block; 4. Anticipated symptom onset to balloon or aspiration time of = 5 hours; 5. The subject and his/her physician are willing to comply with specified follow-up evaluations; 6. The subject or legally authorized representative has been informed of the nature of the study, agrees to its provisions, and has been provided and signed written informed consent, approved by the appropriate Medical Ethics Committee (MEC) or Institutional Review Board (IRB). 7. Infarct artery located in the proximal or mid left anterior descending coronary artery, with TIMI 0/1 flow at the time of initial diagnostic angiography (prior to wire passage); 8. Based on coronary anatomy, PCI is indicated for revascularization; 9. Only one epicardial coronary artery will be treated; 10. Expected ability to deliver a ClearWay™ RX Infusion Catheter to the infarct lesion (absence of excessive tortuosity, diffuse disease or moderate/heavy calcification). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure. 2. Prior myocardial infarction, or known prior systolic dysfunction (known ejection fraction 700,000 cells/mm³ or a Hgb 30 minutes, or requiring IV pressors or emergency IABP for hypotension treatment) or cardiopulmonary resuscitation prior to randomization; 22. Any significant medical condition which in the Investigator's opinion may interfere with the subject?s optimal participation in the study; 23. Currently participating in another investigational drug or device study, which has not completed the primary endpoint follow-up period; 24. Previous enrollment in this study. 25. Coronary anatomy such that coronary artery bypass graft surgery will possibly be required within 30 days; 26. Multivessel intervention required during the index procedure; 27. Severe vessel tortuosity, diffuse disease or severe calcification is present which may impede successful delivery of the ClearWay™ RX Infusion Catheter or the Export ® Aspiration Catheter; 28. Features are present highly unfavorable for PCI; 29. Target lesion is present within a bypass graft conduit; 30. MI is
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to demonstrate that among subjects undergoing primary PCI for anterior STEMI treated with a bivalirudin monotherapy anticoagulation strategy, the intracoronary infusion of an abciximab bolus with or without thrombus aspiration prior to stent implantation, compared to no infusion with or without thrombus aspiration (standard of care), results in 1) reduced infarct size measured by cardiac MRI at 30 days (range -7 days/+14 days; i.e., between 23 and 44 days), 2) reduce microvascular obstruction (MVO) by cardiac MRI at 5 + 2 days (i.e., between 3 and 7 days), 3) enhanced ST-segment resolution, 4) improved myocardial perfusion, 5) reduced thrombus burden and angiographic complications, and 6) no increase in major and minor bleeding. ;Secondary Objective: The secondary objective of the study is to demonstrate that among patients undergoing primary PCI for anterior STEMI treated with a bivalirudin monotherapy anticoagulation strategy with thrombus aspiration compared to no thrombus aspiration prior to stent implantation with or without abciximab bolus results in 1) reduced infarct size and MVO measured by cardiac MRI, 2) enhanced ST-segment resolution, 3) improved myocardial perfusion, 4) reduced thrombus burden and angiographic complications and 5) reduced microvascular obstruction (MVO) by cardiac MRI at 5 + 2 days (i.e., between 3 and 7 days). ;Primary end point(s): Infarct size (percentage of total LV mass) at 30 days (range -7 days/+14 days; i.e., between 23 to 44 days) measured by cardiac MRI, comparing the pooled randomized active (abciximab) infusion (with or without thrombus aspiration) to the pooled non infusion arms (with or without thrombus aspiration). | — |
Countries
Austria, Netherlands, United Kingdom
Outcome results
None listed