Status:
TERMINATED
Multi-cap for Increase Adherence After Acute Myocardial Infarction
Lead Sponsor:
Hospital El Cruce
Conditions:
Myocardial Infarction
Eligibility:
All Genders
18-90 years
Phase:
PHASE3
Brief Summary
Patients who survive an acute coronary syndrome are at high risk of recurrent events and death in the first months of evolution. Aspirin, angiotensin-converting enzyme, beta-blockers and statins decre...
Detailed Description
Sample Size Is estimated according to previous studies adherence to medical treatment 40%, and the objective of the study is to demonstrate an increase in adherence of 25% in absolute terms (40 to 65%...
Eligibility Criteria
Inclusion
- Over 18 years old
- Myocardial infarction within seven (7) days prior: anginal symptoms with ST-segment changes (elevation or depression) or inversion of T waves or left bundle branch block and acute elevation of cardiac enzymes.
- Signature of written informed consent
Exclusion
- Severe ventricular dysfunction, (ejection fraction of the left ventricle less than 40%)
- Contraindication for beta-blockers, angiotensin-converting enzyme, aspirin and / or statins.
- History of allergies or adverse reactions to some of the study drug reactions. Chronic treatment with NSAIDs. Planned coronary-revascularization within six months after discharge.
- Renal failure with estimated creatinine clearance according to the Cockroft-Gault formula less than 30 ml / min.
- Liver or elevated transaminases before randomization more than three times the upper normal limit.
- Higher fasting triglycerides 500 mg / dl.
- Indication according to medical criteria other than a beta-blocker atenolol.
- Indication of oral anticoagulation.
- Failure to follow due to difficulties of geographical access.
Key Trial Info
Start Date :
April 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2016
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT02271178
Start Date
April 1 2014
End Date
September 1 2016
Last Update
January 11 2017
Active Locations (1)
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1
Hospital El Cruce
San Juan Bautista, Buenos Aires, Argentina, 1888