Thrombolysis Versus Primary Angioplasty for AMI in Elderly Patients
Status:
Terminated
Trial end date:
2008-12-01
Target enrollment:
Participant gender:
Summary
General objective: To compare the efficacy and safety of primary angioplasty(PA) with that of
thrombolytic therapy (TT) for the treatment of AMI in patients >=75 years old with ST-segment
elevation or LBBB AMI <6 hours of evolution without contraindications for TT.
Hypothesis: The therapeutical strategy based on PA is superior to that based initially on TT
in patients >=75 years old with AMI.
Participating Centers: 27 Spanish hospitals performing >50 PA/year. Primary Endpoint (PE):
Incidence of the aggregate of death of any cause, reinfarction or disabling stroke at 30
days. There are also 7 secondary endpoints (SE).
Procedure: Diagnosis of inclusion/exclusion criteria --> Centralized randomization -->
Treatment allocation to 1) TT with weight adjusted TNK + unfractionated heparin or 2) PA
within 120 minutes. Estimated Sample size and recruitment time: 570 patients in 19 months.
Follow-up: Blinded evaluation of events (PROBE regulations) specified in PE and SE at 30 days
and 12 months. Quality control: 100% variable and follow-up review by external CRO. Safety
Committee and Event Adjudication Committee formed by experts not participating in the study.
Phase:
Phase 4
Details
Lead Sponsor:
Spanish Society of Cardiology
Collaborators:
Boston Scientific Corporation Cordis Corporation Fondo de Investigacion Sanitaria Guidant Corporation Medtronic Sanofi Sanofi-Synthelabo