Abciximab i.v. Versus i.c. in Primary PCI Patients With STEMI
Phase 2
Completed
- Conditions
- Myocardial Infarction
- Registration Number
- NCT00299377
- Lead Sponsor
- University of Leipzig
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 150
Inclusion Criteria
-
Clinical symptoms:
- Angina < 12 h persistent Angina > 30 min.
-
ECG-Criteria:
- ST-elevation > 1mm in ≥ 2 extremity leads
- ST-elevation > 2mm in ≥ 2 contiguous anterior leads
-
Informed consent
Exclusion Criteria
- No consent
- Pregnancy
- Allergy against abciximab, ASA or heparin
- Active peptic ulcus ventriculi or duodeni
- Active non-superficial bleeding
- Major surgical intervention, intracerebral interventions, puncture central artery < 4 weeks
- Active internal bleeding
- Cerebrovascular complications < 2 years
- Known coagulation disorders, thrombocytopenia
- Arteriovenous malformations or aneurysms
- Severe Liver or renal dysfunction
- Severe untreated hypertension
- Active vasculitis
- Previous thrombolysis < 12 h
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Infarct size and microvascular obstruction assessed by MRI
- Secondary Outcome Measures
Name Time Method ST-segment resolution, TIMI-Flow, TIMI blush grade, ejection fraction, left ventricular volumes, clinical outcome (MACE)
Trial Locations
- Locations (1)
University of Leipzig - Heart Center
🇩🇪Leipzig, Germany