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

Randomized Comparison of Abciximab i.v. Versus i.c. in Primary PCI Patients With STEMI and Effects on Infarct Size and Microvascular Obstruction

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00299377

Enrollment

150

Registered

2006-03-06

Start date

2006-01-31

Completion date

2008-02-29

Last updated

2008-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocardial Infarction

Keywords

STEMI, infarct size, primary PCI, no-reflow, ST-elevation myocardial infarction

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.

Interventions

DRUGAbciximab i.v.

DRUGAbciximab i.c.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Infarct size and microvascular obstruction assessed by MRI	—

Secondary

Measure	Time frame
ST-segment resolution, TIMI-Flow, TIMI blush grade, ejection fraction, left ventricular volumes, clinical outcome (MACE)	—

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 31, 2026