One Versus Twice Daily Administration of Multiple Cardiovascular Agents in Patients With Ischemic Heart Disease

Study Overview
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Brief Summary
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Patients with ischemic heart disease are often treated with multiple cardiovascular agents, including aspirin, statins, ezetimibe, Angiotensin Converting Enzyme (ACE) inhibitors or beta-blockers. Uncertainty about the optimal timing and clinical implications of administration of cardiovascular drugs still persists. The investigators will perform a pilot randomized trial to evaluate the efficacy and safety of a one daily administration of multiple drugs vs. twice daily administration.

Detailed Description
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Patients with ischemic heart disease are often treated with multiple cardiovascular agents, including aspirin, statins, ezetimibe, Angiotensin Converting Enzyme (ACE) inhibitors or beta blockers. These drugs are usually given at different timetables. Recent investigations, however, have demonstrated that adherence to medical treatment is significantly greater if a one daily strategy is adopted. Uncertainty about the optimal timing and clinical implications of administration of cardiovascular drugs still persists. The investigators will perform a pilot randomized trial to evaluate the efficacy and safety of a one daily administration of multiple drugs vs. twice daily administration.

Official Title
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One Versus Twice Daily Administration of Multiple Cardiovascular Agents in Patients With Ischemic Heart Disease: An Open Label, Randomized, Multicenter Study

Conditions
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Ischemic Heart Disease

Intervention / Treatment
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* Drug: Aspirin, Atorvastatin, Perindopril


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ischemic heart disease, willing to participate, compliance to medical therapy Exclusion Criteria: Patients with acute coronary syndrome; pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients will be randomized into two parallel groups
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Once daily drug administration<br>Patients will be given cardiovascular drugs once daily | Drug: Aspirin, Atorvastatin, Perindopril<br>* Cardiovascular drugs will be administered all together every day at the same time<br>|
| Experimental: Twice daily drug administration<br>Patients will be given cardiovascular drugs twice daily | Drug: Aspirin, Atorvastatin, Perindopril<br>* Cardiovascular drugs will be administered all together every day at the same time<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Adverse Outcome Event (MACE) | The time to final occurrence of cardiovascular death, non-fatal myocardial infarction, ischemic stroke or ischemia-driven revascularization | Up to 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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coronary artery disease