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

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04148820
Acronym
ONCE
Enrollment
100
Registered
2019-11-04
Start date
2019-11-01
Completion date
2021-10-31
Last updated
2019-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic Heart Disease

Keywords

coronary artery disease

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.

Interventions

DRUGAspirin, Atorvastatin, Perindopril

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

Sponsors

University of Roma La Sapienza
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Patients will be randomized into two parallel groups

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Patients with acute coronary syndrome; pregnancy

Design outcomes

Primary

MeasureTime frameDescription
Major Adverse Outcome Event (MACE)Up to 1 yearThe time to final occurrence of cardiovascular death, non-fatal myocardial infarction, ischemic stroke or ischemia-driven revascularization

Countries

Italy

Contacts

Primary ContactFrancesco Pelliccia
f.pelliccia@mclink.it+390633062615

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026