Status:
COMPLETED
Abciximab i.v. Versus i.c. in ST-elevation Myocardial Infarction
Lead Sponsor:
University of Leipzig
Conditions:
ST-elevation Myocardial Infarction
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to examine whether intracoronary abciximab bolus application with subsequent 12 hour intravenous infusion in addition to primary percutaneous coronary intervention is bene...
Detailed Description
In patients with acute ST-elevation myocardial infarction (STEMI) primary percutaneous coronary intervention (PCI) is the preferred reperfusion regimen, if performed by experienced operators in a time...
Eligibility Criteria
Inclusion
- Clinical symptoms:
- Angina pectoris \< 12 hours and
- Persistent angina \> 30 minutes
- ECG-criteria for ST-elevation myocardial infarction in 12-lead ECG:
- ST-segment elevation \> 1mm in ≥ 2 extremity leads and/or
- ST-segment elevation \> 2mm in ≥ 2 adjacent precordial leads
- Informed consent
Exclusion
- No informed consent
- Pregnancy
- Known allergy to abciximab, ASA or heparin
- Active peptic ulcus ventriculi or duodeni
- Active, non-superficial bleeding
- History of major surgery (including intracranial or intraspinal) \<4 weeks
- active internal bleeding
- Cerebrovascular complications \< 2 years
- Known coagulation defect or thrombocytopenia
- Arteriovenous malformations or aneurysm
- Severe liver insufficiency, renal insufficiency requiring dialysis
- Uncontrolled hypertension, hypertensive retinopathy
- Vaskulitis
- Thrombolysis \< 12 h
- Participation in another trial
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2011
Estimated Enrollment :
1912 Patients enrolled
Trial Details
Trial ID
NCT00712101
Start Date
July 1 2008
End Date
April 1 2011
Last Update
April 20 2011
Active Locations (11)
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1
Zentralklinik Bad Berka
Bad Berka, Germany, 99437
2
Herz- und Gefäß-KLinik Bad Neustadt
Bad Neustadt an der Saale, Germany, 97616
3
Herz und Diabeteszentrum Bad Oeynhausen
Bad Oeynhausen, Germany, 32545
4
Klinikum Links der Weser - Bremen
Bremen, Germany, 28277