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

NCT ID: NCT04148820

Last Updated: 2019-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-01

Study Completion Date

2021-10-31

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.

Conditions

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Ischemic Heart Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients will be randomized into two parallel groups
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Once daily drug administration

Patients will be given cardiovascular drugs once daily

Group Type EXPERIMENTAL

Aspirin, Atorvastatin, Perindopril

Intervention Type DRUG

Cardiovascular drugs will be administered all together every day at the same time

Twice daily drug administration

Patients will be given cardiovascular drugs twice daily

Group Type EXPERIMENTAL

Aspirin, Atorvastatin, Perindopril

Intervention Type DRUG

Cardiovascular drugs will be administered all together every day at the same time

Interventions

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Aspirin, Atorvastatin, Perindopril

Cardiovascular drugs will be administered all together every day at the same time

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Roma La Sapienza

OTHER

Sponsor Role lead

Responsible Party

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Francesco Pelliccia

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Giuseppe Marazzi

Role: STUDY_DIRECTOR

San Raffaele Pisana

Locations

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San Raffaele Pisana

Rome, , Italy

Site Status

Sapienza University

Rome, , Italy

Site Status

Countries

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Italy

Central Contacts

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Francesco Pelliccia

Role: CONTACT

+390633062615

Other Identifiers

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2019/D/789

Identifier Type: -

Identifier Source: org_study_id

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