A 2x2 Factorial, Randomized, Multicenter, Single-Blind Evaluation of Intracoronary Abciximab Infusion and Aspiration Thrombectomy in Patients Undergoing Percutaneous Coronary Intervention for Anterior ST-Segment Elevation Myocardial Infarction - INFUSE AMI
- Conditions
- The study population will consist of up to 452 male and female subjects with anterior STEMI and occluded proximal or mid LAD with TIMI 0/1/2 flow with indication for primary PCI.MedDRA version: 9.1Level: LLTClassification code 10000891Term: Acute myocardial infarctionMedDRA version: 9.1Level: LLTClassification code 10000904Term: Acute myocardial infarction, of other anterior wall
- Registration Number
- EUCTR2009-013425-42-AT
- Lead Sponsor
- Atrium Medical Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 452
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 0/1/2 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
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 <40% by any prior measure or regional wall motion abnormalities);
3. An elective surgical procedure is planned that would necessitate interruption of anti-platelet agents during the first twelve months post enrollment;
4. Subjects who have prior history of coronary artery bypass graft surgery (CABG);
5. Subjects who previously underwent coronary stent implantation and in whom coronary angiography demonstrates stent thrombosis to be the cause of the AMI;
6. Subject has previously undergone an angioplasty or stenting procedure in the left anterior descending artery;
7. Definite planned use of aspiration, atherectomy, thrombectomy and/or distal protection catheters prior to PTCA or stent implantation (other than in subjects randomized to thrombus aspiration);
8. Any contraindication to undergo MRI imaging.
9. Impaired renal function (creatinine clearance <30 ml/min/1.73m² [or <51.99 cc/min estimated with the Cockcroft-Gault formula]) or on dialysis;
10. Known platelet count <100,000 cells/mm³ or >700,000 cells/mm³ or a Hgb <10g/dL;
11. Intended intracoronary infusion of supersaturated oxygen;
12. Subject has active bleeding or a history of bleeding diathesis or coagulopathy or refusal to receive blood transfusions if necessary;
13. History of intracerebral mass, aneurysm, arteriovenous malformation, or hemorrhagic stroke;
14. Stroke or transient ischemic attack within the past 6 months, or any permanent residual neurologic defect;
15. Gastrointestinal or genitourinary bleeding within the last 2 months, or major surgery within six weeks;
16. Subject has received any organ transplant or is on a waiting list for any organ transplant;
17. Subject has other medical illness that may cause non-compliance with the protocol, confound the data interpretation or is associated with a limited life expectancy of less than one year;
18. Subject has a known hypersensitivity or contraindication to abciximab, aspirin, bivalirudin, clopidogrel, ticlopidine or prasugrel;
19. Subject has a known hypersensitivity or allergy to stainless steel, nickel, cobalt chromium, nitinol, titanium or known hypersensitivity or allergy to contrast media (e.g. rash) that cannot effectively be controlled by premedication with steroids and/or diphenhydramine. Subjects with hypersensitivity or allergy to any of the components of the device (structural, drug or polymer components) and subjects with true prior anaphylaxis to contrast media should not be enrolled.
20. Prior administration of thrombolytic therapy, GP IIb/IIIa inhibitors, low molecular weight heparin or fondaparinux for this admission. Subjects receiving prior unfractionated heparin may be enrolled;
21. Current use of coumadin or coumarin;
22. Subjects presenting with cardiogenic shock (SBP <80 mmHg for >30 minutes, or requiring IV pressors or emergency IABP for hypotension treatment) or cardiopulmonary resuscitation prior to randomization;
23. Subject has received >5000 units of unfractionated heparin within the preceding 24 hours prior to presenting to the catheterization laboratory, or any subject who receives heparin after arrival in the cardiac catheterization laboratory prior to randomization;
24. Any significant medical condition which in the Investigator's opinion may interfere with
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method