Evaluating a polypill for managing coronary risk factors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label, randomized, cross-over study investigates the effectiveness of a polypill containing acetylsalicylic acid, ramipril, and atorvastatin in patients with coronary artery disease. Participants will alternate between taking the polypill and the individual components over a six-month period, with the primary focus on measuring systolic blood pressure and LDL cholesterol levels. The study aims to determine if the polypill improves adherence and health outcomes compared to taking the medications separately. Monthly follow-up visits will ensure proper monitoring and data collection.

Why it matters

Who can join: the full rules

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.

Where it's running

• Hospital Universitario de Cabueñes
  Gijón, Principality of Asturias, Spain Recruiting

Study contacts

• Principal investigator: Iñigo Lozano, MD, PHD — Hospital de Cabueñes, Gijon
• Study coordinator: Iñigo Lozano Martinez-Luengas, MD, PHD
• Email: inigo.lozano@gmail.com
• Phone: +34630901145

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.