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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02271178 |
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Date of registration:
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03/10/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Multi-cap for Increase Adherence After Acute Myocardial Infarction
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Scientific title:
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Multi-cap for Increase Adherence After Acute Myocardial Infarction |
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Date of first enrolment:
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April 2014 |
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Target sample size:
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100 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT02271178 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 3
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Countries of recruitment
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Argentina
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Contacts
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Name:
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Carlos Tajer, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hospital El Cruce |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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 Criteria:
- 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.
Age minimum:
18 Years
Age maximum:
90 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Myocardial Infarction
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Intervention(s)
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Other: Conventional therapy
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Other: Combined capsule
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Primary Outcome(s)
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Adherence
[Time Frame: Six months]
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Secondary Outcome(s)
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Blood pressure, heart rate and cholesterol levels
[Time Frame: Six months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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