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

Phase 4

• Conditions: Ischemic Heart Disease
• Interventions: Drug: Aspirin, Atorvastatin, Perindopril

• Registration Number: NCT04148820
• Lead Sponsor: University of Roma La Sapienza

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2019-10-30
• Study First Submitted QC: 2019-10-30
• Status Verified: 2019-11
• Study Start: 2019-11-01
• Last Update Submitted: 2019-11-01
• Study First Posted: 2019-11-04
• Last Update Posted: 2019-11-05
• Primary Completion: 2021-10-31
• Study Completion: 2021-10-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

Exclusion Criteria

Patients with acute coronary syndrome; pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Once daily drug administration	Aspirin, Atorvastatin, Perindopril	Patients will be given cardiovascular drugs once daily
Twice daily drug administration	Aspirin, Atorvastatin, Perindopril	Patients will be given cardiovascular drugs twice daily

Primary Outcome Measures

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

Trial Locations

Locations (2)

Sapienza University; 🇮🇹 Rome, Italy

San Raffaele Pisana; 🇮🇹 Rome, Italy