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

Myocardial Infarction Clinical Trial

Official title:

A Prospective Randomized Trial of Primary Angioplasty Versus Thrombolytic Therapy for Acute Myocardial Infarction in the Elderly "Senior PAMI"

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00136929
• Other study ID #: HIC 1999-225
• Status: Active, not recruiting
• Phase: N/A
• First received: August 26, 2005
• Last updated: December 12, 2005

Study information

• Verified date: August 2005
• Source: PAMI Coordinating Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 530
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 70 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

Drug:
• Thrombolytic therapy

Procedure:
• Percutaneous coronary intervention (PCI)

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
PAMI Coordinating Center	Eli Lilly and Company, Guidant Corporation