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

Ischemic Heart Disease Clinical Trial

— ONCE  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04148820
• Other study ID #: 2019/D/789
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: November 1, 2019
• Est. completion date: October 31, 2021

Study information

• Verified date: November 2019
• Source: University of Roma La Sapienza
• Contact: Francesco Pelliccia
• Phone: +390633062615
• Email: f.pelliccia[@]mclink.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: October 31, 2021
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Patients with acute coronary syndrome; pregnancy

Related Conditions & MeSH terms

• Coronary Artery Disease
• Heart Diseases
• Ischemia
• Ischemic Heart Disease
• Myocardial Ischemia

Intervention

Drug:
• Aspirin, Atorvastatin, Perindopril
Cardiovascular drugs will be administered all together every day at the same time

Locations

Country	Name	City	State
Italy	San Raffaele Pisana	Rome
Italy	Sapienza University	Rome

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major Adverse Outcome Event (MACE)	The time to final occurrence of cardiovascular death, non-fatal myocardial infarction, ischemic stroke or ischemia-driven revascularization	Up to 1 year