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)
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms by which abciximab improves epicardial flow and reduces no-reflow in STEMI patients undergoing primary PCI?
How does intracoronary abciximab compare to intravenous administration in terms of infarct size reduction and microvascular obstruction in STEMI patients?
What biomarkers are associated with improved outcomes in STEMI patients treated with intracoronary abciximab during primary PCI?
What are the potential adverse events associated with intracoronary abciximab administration in primary PCI for STEMI, and how can they be managed?
How does abciximab compare to other antiplatelet agents like eptifibatide or tirofiban in reducing infarct size and microvascular obstruction in STEMI patients undergoing primary PCI?
Trial Locations
- Locations (1)
University of Leipzig - Heart Center
🇩🇪Leipzig, Germany
University of Leipzig - Heart Center🇩🇪Leipzig, Germany