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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2005 by PAMI Coordinating Center.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Eli Lilly and Company
Guidant Corporation
Information provided by:
PAMI Coordinating Center
ClinicalTrials.gov Identifier:
NCT00136929
First received: August 26, 2005
Last updated: December 12, 2005
Last verified: August 2005
History of Changes
  Purpose

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.


Condition Intervention
Myocardial Infarction
 Drug: Thrombolytic therapy
Procedure: Percutaneous coronary intervention (PCI)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective Randomized Trial of Primary Angioplasty Versus Thrombolytic Therapy for Acute Myocardial Infarction in the Elderly "Senior PAMI"

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by PAMI Coordinating Center:

Estimated Enrollment: 530
  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00136929

Sponsors and Collaborators
PAMI Coordinating Center
Eli Lilly and Company
Guidant Corporation
Investigators
Principal Investigator: Felix Zijlstra, M.D. Ziekenhuis de Weezenlanden
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00136929     History of Changes
Other Study ID Numbers: HIC 1999-225
Study First Received: August 26, 2005
Last Updated: December 12, 2005
Health Authority: United States: Institutional Review Board

Keywords provided by PAMI Coordinating Center:
AMI
MI
Acute myocardial infarction (AMI), (MI)

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
 Vascular Diseases
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Hematologic Agents

ClinicalTrials.gov processed this record on June 18, 2013