Abciximab i.v. Versus i.c. in ST-elevation Myocardial Infarction

• Status: Completed
• Trial end date: 2011-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to examine whether intracoronary abciximab bolus application with subsequent 12 hour intravenous infusion in addition to primary percutaneous coronary intervention is beneficial for patients with STEMI in comparison to standard i.v. bolus application with respect to 90-day mortality, reinfarction and new congestive heart failure.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Leipzig
• Treatments: Abciximab; Antibodies, Monoclonal; Immunoglobulin Fab Fragments

Criteria

Inclusion Criteria:

1. Clinical symptoms:

• Angina pectoris < 12 hours and

• Persistent angina > 30 minutes

2. ECG-criteria for ST-elevation myocardial infarction in 12-lead ECG:

• ST-segment elevation > 1mm in ≥ 2 extremity leads and/or

• ST-segment elevation > 2mm in ≥ 2 adjacent precordial leads

3. Informed consent

Exclusion Criteria:

1. No informed consent

2. Pregnancy

3. Known allergy to abciximab, ASA or heparin

4. Active peptic ulcus ventriculi or duodeni

5. Active, non-superficial bleeding

6. History of major surgery (including intracranial or intraspinal) <4 weeks

7. active internal bleeding

8. Cerebrovascular complications < 2 years

9. Known coagulation defect or thrombocytopenia

10. Arteriovenous malformations or aneurysm

11. Severe liver insufficiency, renal insufficiency requiring dialysis

12. Uncontrolled hypertension, hypertensive retinopathy

13. Vaskulitis

14. Thrombolysis < 12 h

15. Participation in another trial