Cross-over Study of Coronary Risk Factors With a Polypill (POLICROSS)

August 4, 2025 updated by: Fundación EPIC

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

88

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
    • Asturias
      • Gijón, Asturias, Spain, 33203
        • Recruiting
        • Hospital Universitario de Cabueñes
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Patients over 18 years of age. Patients under treatment with the Trinomia® polypill in any of its presentations for indication of secondary prevention and who can make the 6 visits necessary to complete the study. Patients who sign the Informed Consent.

Exclusion Criteria:

Patients who do not sign the informed consent. Patients with an inability to understand and comply with the protocol. Patients with contraindication to any component of the polypill. Patients who are already participating in another clinical trial. Patients with any condition that limits life expectancy to <1 year. Patients with programmed coronary revascularization. Patients with coronary stent implantation in the last 12 months. Patients treated with any antithrombotic drug in addition to acetylsalicylic acid, that is, low molecular weight heparin, P2Y12 receptor inhibitors, or oral anticoagulants.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Polypill
Patients will be receiving the polypill at the adequate doses during 3 months
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
Active Comparator: Drugs taken separately
Patients will be receiving during 3 months the same components and at the same doses than with the polypill
Drug: Polypill of acetylsalicylic acid, ramipril and atorvastatin
Administration of acetylsalicylic acid, ramipril and atorvastatin in a polypill during 3 months more

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
LDL-cholesterol
Time Frame: Months 2 and 3 vs. Months 5 and 6
Mean of absolute level of LDL cholesterol
Months 2 and 3 vs. Months 5 and 6
Systolic blood pressure
Time Frame: Months 2 and 3 vs. Months 5 and 6
Mean of absolute level of systolic blood pressure
Months 2 and 3 vs. Months 5 and 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación EPIC

Investigators

  • Principal Investigator: Iñigo Lozano, MD, PHD, Hospital de Cabueñes, Gijon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 14, 2022

Primary Completion (Estimated)

March 30, 2026

Study Completion (Estimated)

April 30, 2026

Study Registration Dates

First Submitted

August 30, 2021

First Submitted That Met QC Criteria

August 30, 2021

First Posted (Actual)

September 1, 2021

Study Record Updates

Last Update Posted (Actual)

August 5, 2025

Last Update Submitted That Met QC Criteria

August 4, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • POLICROSS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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