NCT05030818RecruitingPhase 4
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
Source: ClinicalTrials.gov · Last updated 5 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 88 (estimated)
- First submitted
- 30 Aug 2021
- Start date
- 14 Oct 2022
- Primary completion date
- 30 Mar 2026
- Lead sponsor
- Fundación EPIC
- NCT number
- NCT05030818
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 88
- From 14 Oct 2022 to the primary completion date, 30 Mar 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitario de Cabueñes Coordinator of this site? Confirm its status | Gijón | Spain | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.