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
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Sponsor:
PAMI Coordinating Center
Collaborators:
Eli Lilly and Company
Guidant Corporation
Information provided by:
PAMI Coordinating Center
Tracking Information | ||||
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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 |
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Condition ICMJE | Myocardial Infarction | |||
Intervention ICMJE |
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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. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Unknown status | |||
Enrollment ICMJE |
530 | |||
Original Enrollment ICMJE | Same as current | |||
Study Completion Date ICMJE | Not Provided | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 |
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Investigators ICMJE |
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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 |