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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

Tracking Information
First Submitted Date  ICMJE August 26, 2005
First Posted Date  ICMJE August 29, 2005
Last Update Posted Date December 13, 2005
Study Start Date  ICMJE Not Provided
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Senior PAMI: Primary Angioplasty Versus Thrombolytic Therapy for Acute Myocardial Infarction in the Elderly
Official Title  ICMJE A Prospective Randomized Trial of Primary Angioplasty Versus Thrombolytic Therapy for Acute Myocardial Infarction in the Elderly "Senior PAMI"
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Myocardial Infarction
Intervention  ICMJE
  • Drug: Thrombolytic therapy
  • Procedure: Percutaneous coronary intervention (PCI)
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Enrollment  ICMJE
 (submitted: August¬†26,¬†2005)
530
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 70 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00136929
Other Study ID Numbers  ICMJE HIC 1999-225
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE PAMI Coordinating Center
Collaborators  ICMJE
  • Eli Lilly and Company
  • Guidant Corporation
Investigators  ICMJE
Principal Investigator: Felix Zijlstra, M.D. Ziekenhuis de Weezenlanden
PRS Account PAMI Coordinating Center
Verification Date August 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP