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

University of Leipzig150 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

150

Conditions

Myocardial Infarction

Interventions

Abciximab i.v.DRUG

Abciximab i.c.DRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Leipzig - Heart Center

Leipzig, Germany

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)

Data from ClinicalTrials.gov

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