Evaluating a polypill for managing coronary risk factors
Cross-over Analysis of the Control of Coronary Risk Factors and Level of Platelet Inhibition With a Polypill
PHASE4 · Fundación EPIC · NCT05030818
This study tests if a combined pill with three heart medications can help people with coronary artery disease manage their blood pressure and cholesterol better than taking the medications separately.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 88 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fundación EPIC (other) |
| Locations | 1 site (Gijón, Principality of Asturias) |
| Trial ID | NCT05030818 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old currently using the Trinomia® polypill for secondary prevention of cardiovascular disease.
Not a fit: Patients with contraindications to any component of the polypill or those with life expectancy limitations may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance treatment adherence and improve cardiovascular health outcomes for patients with coronary artery disease.
How similar studies have performed: While there have been successful studies on polypills for cardiovascular prevention, this specific cross-over design comparing the polypill to its individual components is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Gijón, Principality of Asturias
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Coronary Artery Disease, Hypertension, LDL-cholesterol, Platelet inhibition