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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. The completion date has passed and the status has not been verified in more than two years.
Verified August 2005 by PAMI Coordinating Center.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00136929
First Posted: August 29, 2005
Last Update Posted: December 13, 2005
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.
Collaborators:
Eli Lilly and Company
Guidant Corporation
Information provided by:
PAMI Coordinating Center
  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
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 NLM:


Further study details as provided by PAMI Coordinating Center:

Estimated Enrollment: 530
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   70 Years and older   (Senior)
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
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 ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00136929     History of Changes
Other Study ID Numbers: HIC 1999-225
First Submitted: August 26, 2005
First Posted: August 29, 2005
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:
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