NCT00299377CompletedPhase 2
Randomized Comparison of Abciximab i.v. Versus i.c. in Primary PCI Patients With STEMI and Effects on Infarct Size and Microvascular Obstruction
University of Leipzig2 sites in 1 country150 target enrollmentStarted: January 1, 2006Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 150
- Locations
- 2
- Primary Endpoint
- Infarct size and microvascular obstruction assessed by MRI
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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
Outcomes
Primary Outcomes
Infarct size and microvascular obstruction assessed by MRI
Secondary Outcomes
- ST-segment resolution, TIMI-Flow, TIMI blush grade, ejection fraction, left ventricular volumes, clinical outcome (MACE)
Investigators
Study Sites (2)
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