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

University of Leipzig

Status and phase: Completed; Phase 3; Phase 2

Conditions: Myocardial Infarction

Treatments: Drug: Abciximab i.c.; Drug: Abciximab i.v.

Study type: Interventional

Funder types: Other

Identifiers

NCT00299377

1-Thiele

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind