Overview

This trial is active, not recruiting.

Condition myocardial infarction
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

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Eligibility Criteria

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)

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2005.
Information provided to ClinicalTrials.gov by PAMI Coordinating Center.