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

NCT04148820 | Unknown Phase 4

• 1 other identifier: 2019/D/789
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Ischemic Heart Disease

Keywords

coronary artery disease

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Once daily drug administration

EXPERIMENTAL

Patients will be given cardiovascular drugs once daily

Drug: Aspirin, Atorvastatin, Perindopril

Twice daily drug administration

EXPERIMENTAL

Patients will be given cardiovascular drugs twice daily

Drug: Aspirin, Atorvastatin, Perindopril

Interventions

Aspirin, Atorvastatin, Perindopril DRUG

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

Once daily drug administration; Twice daily drug administration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients with acute coronary syndrome; pregnancy

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (2)

San Raffaele Pisana

Rome, 00100, Italy

Location

Sapienza University

Rome, 00161, Italy

Location

MeSH Terms

Conditions

Myocardial Ischemia; Coronary Artery Disease

Interventions

Aspirin; Atorvastatin; Perindopril

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Giuseppe Marazzi

  San Raffaele Pisana

  STUDY DIRECTOR

Central Study Contacts

Francesco Pelliccia

CONTACT

+390633062615; f.pelliccia@mclink.it

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Patients will be randomized into two parallel groups

Study Record Dates

• First Submitted: October 30, 2019
• First Posted: November 4, 2019
• Study Start: November 1, 2019
• Primary Completion: October 31, 2021
• Study Completion: October 31, 2021
• Last Updated: November 5, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)