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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00136929
Recruitment Status : Unknown
Verified August 2005 by PAMI Coordinating Center.
Recruitment status was:  Active, not recruiting
First Posted : August 29, 2005
Last Update Posted : December 13, 2005
Eli Lilly and Company
Guidant Corporation
Information provided by:
PAMI Coordinating Center

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.

Condition or disease Intervention/treatment Phase
Myocardial Infarction Drug: Thrombolytic therapy Procedure: Percutaneous coronary intervention (PCI) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Enrollment : 530 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (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 the National Library of Medicine

Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00136929

Sponsors and Collaborators
PAMI Coordinating Center
Eli Lilly and Company
Guidant Corporation
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Principal Investigator: Felix Zijlstra, M.D. Ziekenhuis de Weezenlanden
Layout table for additonal information Identifier: NCT00136929    
Other Study ID Numbers: HIC 1999-225
First Posted: August 29, 2005    Key Record Dates
Last Update Posted: December 13, 2005
Last Verified: August 2005
Keywords provided by PAMI Coordinating Center:
Acute myocardial infarction (AMI), (MI)
Additional relevant MeSH terms:
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Myocardial Infarction
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action