Senior PAMI: Primary Angioplasty Versus Thrombolytic Therapy for Acute Myocardial Infarction in the Elderly
Not Applicable
- Conditions
- Myocardial Infarction
- Registration Number
- NCT00136929
- Lead Sponsor
- PAMI Coordinating Center
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 530
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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method