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

November 1, 2019 updated by: Francesco Pelliccia, University of Roma La Sapienza

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Rome, Italy, 00161
        • Sapienza University
      • Rome, Italy, 00100
        • San Raffaele Pisana

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

Patients with acute coronary syndrome; pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Once daily drug administration
Patients will be given cardiovascular drugs once daily
Drug: Aspirin, Atorvastatin, Perindopril
Cardiovascular drugs will be administered all together every day at the same time
Experimental: Twice daily drug administration
Patients will be given cardiovascular drugs twice daily
Drug: Aspirin, Atorvastatin, Perindopril
Cardiovascular drugs will be administered all together every day at the same time

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Roma La Sapienza

Investigators

  • Study Director: Giuseppe Marazzi, San Raffaele Pisana

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 1, 2019

Primary Completion (Anticipated)

October 31, 2021

Study Completion (Anticipated)

October 31, 2021

Study Registration Dates

First Submitted

October 30, 2019

First Submitted That Met QC Criteria

October 30, 2019

First Posted (Actual)

November 4, 2019

Study Record Updates

Last Update Posted (Actual)

November 5, 2019

Last Update Submitted That Met QC Criteria

November 1, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019/D/789

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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