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

U

University of Roma La Sapienza

Status and phase

Unknown
Phase 4

Conditions

Ischemic Heart Disease

Treatments

Drug: Aspirin, Atorvastatin, Perindopril

Study type

Interventional

Funder types

Other

Identifiers

NCT04148820
2019/D/789

Details and patient eligibility

About

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 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.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

Patients with acute coronary syndrome; pregnancy

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

100 participants in 2 patient groups

Once daily drug administration
Experimental group
Description:
Patients will be given cardiovascular drugs once daily
Treatment:
Drug: Aspirin, Atorvastatin, Perindopril
Twice daily drug administration
Experimental group
Description:
Patients will be given cardiovascular drugs twice daily
Treatment:
Drug: Aspirin, Atorvastatin, Perindopril

Trial contacts and locations

2

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Central trial contact

Francesco Pelliccia

Data sourced from clinicaltrials.gov

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