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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2008-02-29

Brief Summary

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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

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Conditions

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Myocardial Infarction

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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Abciximab i.v.

Intervention Type DRUG

Abciximab i.c.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Holger Thiele

Role: PRINCIPAL_INVESTIGATOR

Heart Center Leipzig - University Hospital

Locations

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University of Leipzig - Heart Center

Leipzig, , Germany

Site Status

Countries

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Germany

References

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de Waha S, Desch S, Eitel I, Fuernau G, Zachrau J, Leuschner A, Gutberlet M, Schuler G, Thiele H. Impact of early vs. late microvascular obstruction assessed by magnetic resonance imaging on long-term outcome after ST-elevation myocardial infarction: a comparison with traditional prognostic markers. Eur Heart J. 2010 Nov;31(21):2660-8. doi: 10.1093/eurheartj/ehq247. Epub 2010 Jul 30.

Reference Type DERIVED

PMID: 20675660 (View on PubMed)

Thiele H, Schindler K, Friedenberger J, Eitel I, Furnau G, Grebe E, Erbs S, Linke A, Mobius-Winkler S, Kivelitz D, Schuler G. Intracoronary compared with intravenous bolus abciximab application in patients with ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention: the randomized Leipzig immediate percutaneous coronary intervention abciximab IV versus IC in ST-elevation myocardial infarction trial. Circulation. 2008 Jul 1;118(1):49-57. doi: 10.1161/CIRCULATIONAHA.107.747642. Epub 2008 Jun 16.