Clinical trial NCT00299377: Abciximab i.v. Versus i.c. in Primary PCI Patients With STEMI
Official title: Randomized Comparison of Abciximab i.v. Versus i.c. in Primary PCI Patients With STEMI and Effects on Infarct Size and Microvascular Obstruction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Myocardial Infarction
Keywords: STEMI
infarct size
primary PCI
no-reflow
ST-elevation myocardial infarction
Lead sponsor: University of Leipzig
Sponsor class: OTHER
First posted: 2006-03-06
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Infarct size and microvascular obstruction assessed by MRI
Secondary outcomes:
measure: ST-segment resolution, TIMI-Flow, TIMI blush grade, ejection fraction, left ventricular volumes, clinical outcome (MACE)
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: University of Leipzig - Heart Center
Study officials:
affiliation: Heart Center Leipzig - University Hospital
name: Holger Thiele
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.