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

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ClinicalTrials.gov 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
Sponsor:
Collaborators:
Eli Lilly and Company
Guidant Corporation
Information provided by:
PAMI Coordinating Center

Study Description
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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

Study Design
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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"

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Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
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
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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 ClinicalTrials.gov identifier (NCT number): NCT00136929


Sponsors and Collaborators
PAMI Coordinating Center
Eli Lilly and Company
Guidant Corporation
Investigators
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Principal Investigator: Felix Zijlstra, M.D. Ziekenhuis de Weezenlanden
More Information
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ClinicalTrials.gov 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:
AMI
MI
Acute myocardial infarction (AMI), (MI)
Additional relevant MeSH terms:
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Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
 Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action