Status:
COMPLETED
Beyond 12 Hours Reperfusion AlternatiVe Evaluation Trial
Lead Sponsor:
Deutsches Herzzentrum Muenchen
Collaborating Sponsors:
Technical University of Munich
Conditions:
Myocardial Infarction
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
The objective of this international, multicenter, randomized study is to assess whether coronary artery stenting is associated with a reduced infarct size in patients with AMI presenting between 12 an...
Detailed Description
Between 8.5% and 40% of patients with acute myocardial infarction present late after symptom onset, no longer being eligible for thrombolysis.Despite efforts to reduce time to presentation, recent stu...
Eligibility Criteria
Inclusion
- patients fulfilling the criteria of AMI and presenting at the hospital between 12 and 48 hours after onset of symptoms. The criteria of AMI are fulfilled when at least one episode of typical chest pain lasting ≥ 20 minutes is combined with either unequivocal ECG changes (≥ 0.1 mV of ST-segment elevation in ≥ 2 limb leads or ≥ 0.2 mV in ≥ 2 contiguous precordial leads or new pathological Q-waves) or CK plus concomitant CK-MB increase above twice the upper normal threshold. All patients have to be informed of the nature of the study and should give their informed consent for participation in the study.
Exclusion
- Age \<18 years and \> 80 years
- Cardiogenic shock (systolic blood pressure \< 80 mm Hg unresponsive to fluids or necessitating the infusion of catecholamines: GUSTO I criteria)
- Persistent severe chest pain
- Prior thrombolysis (for index AMI)
- Malignancies with life expectancy \< 1year
- History of bleeding diathesis, coagulopathy
- Contraindications to the antithrombotic therapy used in conjunction with coronary stenting (clopidogrel and abciximab)
- Stroke within the past 3 months
- Major surgery within the past 30 days
- Platelets \< 100000/mm3 or \>700000/mm3, Hb \< 10g/dl, white blood cell count \<3000/mm3
- Percutaneous coronary intervention within the past 30 days
- Inability to cooperate with study procedures and/or follow-up
- Previous enrollment in this trial
Key Trial Info
Start Date :
May 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2005
Estimated Enrollment :
365 Patients enrolled
Trial Details
Trial ID
NCT00759629
Start Date
May 1 2001
End Date
August 1 2005
Last Update
September 25 2008
Active Locations (14)
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1
Landeskrankenhaus Feldkirch
Feldkirch, Austria
2
Staedtisches Krankenhaus Bad Reichenhall
Bad Reichenhall, Germany
3
Kreiskrankenhaus Erding/Dorfen
Erding, Germany, 85435
4
Kreiskrankenhaus Freilassing
Freilassing, Germany