NCT05030818 Cross-over Study of Coronary Risk Factors With a Polypill
| NCT ID | NCT05030818 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Fundación EPIC |
| Condition | Coronary Artery Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 88 participants |
| Start Date | 2022-10-14 |
| Primary Completion | 2026-03-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 88 participants in total. It began in 2022-10-14 with a primary completion date of 2026-03-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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.
Contact & Investigator
Iñigo Lozano, MD, PHD
PRINCIPAL INVESTIGATOR
Hospital de Cabueñes, Gijon
Frequently Asked Questions
Who can join the NCT05030818 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Coronary Artery Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05030818 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05030818 currently recruiting?
Yes, NCT05030818 is actively recruiting participants. Contact the research team at inigo.lozano@gmail.com for enrollment information.
Where is the NCT05030818 trial being conducted?
This trial is being conducted at Gijón, Spain.
Who is sponsoring the NCT05030818 clinical trial?
NCT05030818 is sponsored by Fundación EPIC. The principal investigator is Iñigo Lozano, MD, PHD at Hospital de Cabueñes, Gijon. The trial plans to enroll 88 participants.