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
Sponsored by
About this trial
This is an interventional treatment trial for Ischemic Heart Disease focused on measuring coronary artery disease
Eligibility Criteria
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
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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
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
No
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
Email
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
No
Learn more about this trial
One Versus Twice Daily Administration of Multiple Cardiovascular Agents in Patients With Ischemic Heart Disease
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