Multi-cap for Increase Adherence After Acute Myocardial Infarction

NCT02271178 | Terminated Phase 3

• 1 other identifier: 001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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 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

Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

• Adherence

  The adherence will be measures by pill count. It will presented as the percentage of pill taken on total theoretical pill that should be taken during the study period.

  Six months

Secondary Outcomes (1)

• Blood pressure, heart rate and cholesterol levels

  Six months

Other Outcomes (1)

• Platelet aggregation

  Six months

Study Arms (2)

Combined capsule

EXPERIMENTAL

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: Combined capsule

Conventional treatment

OTHER

Usual therapy

Other: Conventional therapy

Interventions

Combined capsule OTHER

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.

Also known as: Multi-cap.

Combined capsule

Conventional therapy OTHER

Usual therapy

Conventional treatment

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital El Cruce: lead

Study Sites (1)

Hospital El Cruce

San Juan Bautista, Buenos Aires, 1888, Argentina

Location

Related Publications (1)

• Mariani J, Rosende A, De Abreu M, Gonzalez Villa Monte G, D'Imperio H, Antonietti L, Lemonnier G, de Bonis A, Tajer C. Multicap to improve adherence after acute coronary syndromes: results of a randomized controlled clinical trial. Ther Adv Cardiovasc Dis. 2020 Jan-Dec;14:1753944720912071. doi: 10.1177/1753944720912071.

  PMID: 32186246 DERIVED

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Carlos Tajer, MD

  Hospital El Cruce

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 3, 2014
• First Posted: October 22, 2014
• Study Start: April 1, 2014
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: January 11, 2017

Record last verified: 2017-01

Locations

AR (1)