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Multi-cap for Increase Adherence After Acute Myocardial Infarction

NCT02271178 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2017-01-11

No results posted yet for this study

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 decrease the risk of recurrent events and death, so are the recommended treatment for most patients who had a heart attack, and adherence to these recommendations is associated better clinical outcome. However, numerous studies show high dropout rate of medical treatment. The cause of nonadherence, common problem in chronic diseases, is multifactorial (economic, cultural, adverse effects), the complexity of the treatment being prescribed a relevant factor as a cause of non-compliance. The investigators goal is to assess whether the simplification of treatment for secondary prevention in a once-daily capsule containing four drugs increased adherence to it, compared to the standard treatment of each drug separately.

The investigators design a controlled, randomized, open, parallel-group clinical study. Patients will be randomized to one of the following treatment regimens:

* Combined-Capsule: capsule containing an adjusted patient combination scheme for secondary prevention of once daily.
* Usual-treatment: each component of the dish separately as is the usual practice.

The primary endpoint is the adherence of the treatment regimen to secondary prevention. For the study was considered adherent to a patient taking at least 80% of medication that belongs in the period.

Conditions

Interventions

OTHER

Combined capsule

Combined capsule containing ramipril (5 to 10 mg), atenolol (50 to 100 mg), 100 mg aspirin, 40 mg simvastatin. In follow-up visits doses of atenolol and ramipril capsules may be adjusted according to blood pressure and heart rate.

OTHER

Conventional therapy

Usual therapy

Sponsors & Collaborators

  • Hospital El Cruce

    lead OTHER

Principal Investigators

  • Carlos Tajer, MD · Hospital El Cruce

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2016-09-30
Completion
2016-09-30

Countries

  • Argentina

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02271178 on ClinicalTrials.gov