Back to results

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

Primary Purpose

Ischemic Heart Disease

Status

Unknown status

Phase

Phase 4

Locations

Italy

Study Type

Interventional

Intervention

Aspirin, Atorvastatin, Perindopril

About this trial

This is an interventional treatment trial for Ischemic Heart Disease focused on measuring coronary artery disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Patients with acute coronary syndrome; pregnancy

Sites / Locations

San Raffaele Pisana
Sapienza University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Once daily drug administration

Twice daily drug administration

Arm Description

Patients will be given cardiovascular drugs once daily

Patients will be given cardiovascular drugs twice daily

Outcomes

Primary Outcome Measures

Major Adverse Outcome Event (MACE)

The time to final occurrence of cardiovascular death, non-fatal myocardial infarction, ischemic stroke or ischemia-driven revascularization

Secondary Outcome Measures

Full Information

NCT ID

NCT04148820

First Posted

October 30, 2019

Last Updated

November 1, 2019

Sponsor

University of Roma La Sapienza

1. Study Identification

Unique Protocol Identification Number

NCT04148820

Brief Title

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

Acronym

ONCE

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2019

Overall Recruitment Status

Unknown status

Study Start Date

November 1, 2019 (Anticipated)

Primary Completion Date

October 31, 2021 (Anticipated)

Study Completion Date

October 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Roma La Sapienza

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ischemic Heart Disease

Keywords

coronary artery disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Model Description

Patients will be randomized into two parallel groups

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Once daily drug administration

Arm Type

Experimental

Arm Description

Patients will be given cardiovascular drugs once daily

Arm Title

Twice daily drug administration

Arm Type

Experimental

Arm Description

Patients will be given cardiovascular drugs twice daily

Intervention Type

Drug

Intervention Name(s)

Aspirin, Atorvastatin, Perindopril

Intervention Description

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

Primary Outcome Measure Information:

Title

Major Adverse Outcome Event (MACE)

Description

The time to final occurrence of cardiovascular death, non-fatal myocardial infarction, ischemic stroke or ischemia-driven revascularization

Time Frame

Up to 1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Francesco Pelliccia

Phone

+390633062615

f.pelliccia@mclink.it

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Giuseppe Marazzi

Organizational Affiliation

San Raffaele Pisana

Official's Role

Study Director

Facility Information:

Facility Name

San Raffaele Pisana

City

Rome

ZIP/Postal Code

00100

Country

Italy

Facility Name

Sapienza University

City

Rome

ZIP/Postal Code

00161

Country

Italy

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

We'll reach out to this number within 24 hrs