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

PAMI Coordinating Center

Status

Unknown

Conditions

Myocardial Infarction

Treatments

Drug: Thrombolytic therapy

Procedure: Percutaneous coronary intervention (PCI)

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00136929

HIC 1999-225

Details and patient eligibility

About

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.

Sex

All

Ages

70+ years old

Volunteers

Accepts Healthy Volunteers

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)