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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 31, 2021

Detailed Description

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.

Interventions

  • Drug: Aspirin, Atorvastatin, Perindopril
    • Cardiovascular drugs will be administered all together every day at the same time

Arms, Groups and Cohorts

  • Experimental: Once daily drug administration
    • Patients will be given cardiovascular drugs once daily
  • Experimental: Twice daily drug administration
    • Patients will be given cardiovascular drugs twice daily

Clinical Trial Outcome Measures

Primary Measures

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

Participating in This Clinical Trial

Inclusion Criteria

Ischemic heart disease, willing to participate, compliance to medical therapy

Exclusion Criteria

Patients with acute coronary syndrome; pregnancy

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Roma La Sapienza
  • Provider of Information About this Clinical Study
    • Principal Investigator: Francesco Pelliccia, Professor – University of Roma La Sapienza
  • Overall Official(s)
    • Giuseppe Marazzi, Study Director, San Raffaele Pisana
  • Overall Contact(s)
    • Francesco Pelliccia, +390633062615, f.pelliccia@mclink.it

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