- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00136929
Senior PAMI: Primary Angioplasty Versus Thrombolytic Therapy for Acute Myocardial Infarction in the Elderly
December 12, 2005 updated by: PAMI Coordinating Center
A Prospective Randomized Trial of Primary Angioplasty Versus Thrombolytic Therapy for Acute Myocardial Infarction in the Elderly "Senior PAMI"
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
530
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
70 years and older (Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Felix Zijlstra, M.D., Ziekenhuis de Weezenlanden
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
August 26, 2005
First Submitted That Met QC Criteria
August 26, 2005
First Posted (Estimate)
August 29, 2005
Study Record Updates
Last Update Posted (Estimate)
December 13, 2005
Last Update Submitted That Met QC Criteria
December 12, 2005
Last Verified
August 1, 2005
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HIC 1999-225
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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