NCT05030818

Cross-over Study of Coronary Risk Factors With a Polypill

Cross-over Analysis of the Control of Coronary Risk Factors and Level of Platelet Inhibition With a Polypill

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 88 (estimated)
• Sponsor: Fundación EPIC · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Open-label, randomized, cross-over study conducted in a single center, applied to patients receiving a polypill with 100 mg of acetyl salicylic acid and different doses of ramipril and atorvastatin for indication of secondary prevention according to clinical practice, with objective of analyzing the level of systolic blood pressure and LDL-cholesterol in the same patient in 2 different periods: one under treatment of 3 months with the polypill and another of 3 months with the components separately.

Detailed description

The European Society of Cardiology indicates that reducing the frequency of administration is the most effective measure to improve therapeutic adherence. Current guidelines recommend with class I and level of evidence A the use of polypills. A polypill, composed of 100 mg of acetylsalicylic acid and variable doses of atorvastatin and ramipril, is approved for secondary prevention of cardiovascular disease and has also been widely used in primary prevention. Numerous studies have been carried out focusing on different designs of polypill in cardiovascular prevention to study their efficacy, cost-effectiveness and administration schedule. Specifically, that polypill already has an extensive literature. However, although there are previous studies with a cross-over design with other types of polypill to assess the effects on the control of arterial hypertension and LDL cholesterol, to date there has never been a cross-over design study with the polypill compared to the administration of its components separately in the control of blood pressure, lipid level and level of platelet aggregation. Patients will be randomized to polypill vs separate components. Each patient will receive a follow-up visit per month for 6 months, of which will be 3 consecutive months with treatment with the polypill in its corresponding dose and the remaining 3 months with the same drugs separately. Primary objectives: Systolic blood pressure level and LDL cholesterol. Secondary objectives: Degree of platelet aggregation with thromboxane A2 kit, diastolic blood pressure level, total cholesterol and HDL, level of patient satisfaction, degree of adherence to treatment, adverse events.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DRUG	Polypill of acetylsalicylic acid, ramipril and atorvastatin	Administration of acetylsalicylic acid, ramipril and atorvastatin in a polypill during 3 months more
DRUG	Drugs taken separately: acetylsalicylic acid, ramipril and atorvastatin	Patients will be receiving during 3 months more the same components acetylsalicylic acid, ramipril and atorvastatin than with the polypill

Timeline

• Start date: 2022-10-14
• Primary completion: 2026-03-30
• Completion: 2026-04-30
• First posted: 2021-09-01
• Last updated: 2025-08-05

Locations

1 site across 1 country: Spain