Abciximab i.v. Versus i.c. in Primary PCI Patients With STEMI

• Status: Completed
• Trial end date: 2008-02-01
• Target enrollment: 0
• Participant gender: All

Summary

Randomized comparison of abciximab i.v. versus i.c. in patients with STEMI undergoing primary PCI. The hypothesis is, that higher concentration of abciximab i.c. leads to improved epicardial flow, perfusion, reduction of no-reflow, reduction in infarct size and subsequently better outcome.

• Phase: Phase 2/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 < 12 h persistent Angina > 30 min.

2. ECG-Criteria:

• ST-elevation > 1mm in ≥ 2 extremity leads

• ST-elevation > 2mm in ≥ 2 contiguous anterior leads

3. Informed consent

Exclusion Criteria:

1. No consent

2. Pregnancy

3. Allergy against abciximab, ASA or heparin

4. Active peptic ulcus ventriculi or duodeni

5. Active non-superficial bleeding

6. Major surgical intervention, intracerebral interventions, puncture central artery < 4 weeks

7. Active internal bleeding

8. Cerebrovascular complications < 2 years

9. Known coagulation disorders, thrombocytopenia

10. Arteriovenous malformations or aneurysms

11. Severe Liver or renal dysfunction

12. Severe untreated hypertension

13. Active vasculitis

14. Previous thrombolysis < 12 h