Myocardial Infarction
Conditions
Keywords
AMI, MI, Acute myocardial infarction (AMI), (MI)
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.
Interventions
DRUGThrombolytic therapy
PROCEDUREPercutaneous coronary intervention (PCI)
Sponsors
Eli Lilly and Company
Guidant Corporation
PAMI Coordinating Center
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
Yes
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)
Outcome results
None listed