Senior PAMI: Primary Angioplasty Versus Thrombolytic Therapy for Acute Myocardial Infarction in the Elderly
This trial is active, not recruiting.
|Treatments||thrombolytic therapy, percutaneous coronary intervention (pci)|
|Sponsor||PAMI Coordinating Center|
|Collaborator||Eli Lilly and Company|
|Trial size||530 participants|
|Trial identifier||NCT00136929, HIC 1999-225|
This is a prospective, randomized, multi-center, international trial comparing two reperfusion strategies in elderly (age >= 70 years) patients with acute myocardial infarction: primary percutaneous coronary intervention (PCI) versus intravenous thrombolytic therapy. Clinical endpoints will be collected in the hospital, at 1 month, 6 months, and 1 year post-randomization. The primary endpoint is 30 day death or disabling stroke. The study null hypothesis is that there will be no significant difference in death or disabling stroke at 30 days post-randomization between patients treated with PCI versus thrombolytics.
|Endpoint classification||safety study|
|Intervention model||single group assignment|
Male or female participants at least 70 years old.
Inclusion Criteria: - Age >= 70 - Clinical symptoms > 30 minutes - Symptom onset <= 12 hours - ST segment elevation >= 1 mm in 2 or more leads Exclusion Criteria: - Prior thrombolytics - Cardiogenic shock - Cerebrovascular accident (CVA) - Prolonged cardiopulmonary resuscitation (CPR) - Blood pressure (BP) > 180/100 mm Hg - Active bleeding - International Normalized Ratio (INR) > 1.4 - Acetylsalicylic acid [aspirin] (ASA) or heparin allergy - History of neutropenia, thrombocytopenia, hepatic dysfunction, or renal insufficiency - Peripheral vascular disease (PVD)
|Official title||A Prospective Randomized Trial of Primary Angioplasty Versus Thrombolytic Therapy for Acute Myocardial Infarction in the Elderly "Senior PAMI"|
|Principal investigator||Felix Zijlstra, M.D.|
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