Senior PAMI: Primary Angioplasty Versus Thrombolytic Therapy for Acute Myocardial Infarction in the Elderly

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: PAMI Coordinating Center
• Collaborators: Eli Lilly and Company; Guidant Corporation
• Treatments: Fibrinolytic Agents

Criteria

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)