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Trial record 77 of 116 for:    Atenolol

Multi-cap for Increase Adherence After Acute Myocardial Infarction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02271178
Recruitment Status : Terminated (The study was stopped after interim analysis due to futility.)
First Posted : October 22, 2014
Last Update Posted : January 11, 2017
Sponsor:
Information provided by (Responsible Party):
Carlos Tajer, Hospital El Cruce

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.


Condition or disease Intervention/treatment Phase
Myocardial Infarction Other: Combined capsule Other: Conventional therapy Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multi-cap for Increase Adherence After Acute Myocardial Infarction
Study Start Date : April 2014
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
Experimental: 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: 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 Name: Multi-cap.

Conventional treatment
Usual therapy
Other: Conventional therapy
Usual therapy




Primary Outcome Measures :
  1. Adherence [ Time Frame: Six months ]
    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.


Secondary Outcome Measures :
  1. Blood pressure, heart rate and cholesterol levels [ Time Frame: Six months ]
    Measurement of blood pressure, heart rate and plasma levels of cholesterol.


Other Outcome Measures:
  1. Platelet aggregation [ Time Frame: Six months ]
    Measurement of platelet aggregation inhibition by aspirin. This outcome will be measured in a random subset of patients.



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02271178


Locations
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Argentina
Hospital El Cruce
Florencio Varela, Buenos Aires, Argentina, 1888
Sponsors and Collaborators
Hospital El Cruce
Investigators
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Principal Investigator: Carlos Tajer, MD Hospital El Cruce

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Responsible Party: Carlos Tajer, MD, Hospital El Cruce
ClinicalTrials.gov Identifier: NCT02271178     History of Changes
Other Study ID Numbers: 001
First Posted: October 22, 2014    Key Record Dates
Last Update Posted: January 11, 2017
Last Verified: January 2017
Additional relevant MeSH terms:
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Atenolol
Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Ramipril
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Anti-Arrhythmia Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents