RecruitingPhase 4NCT05030818

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

Sponsor

Fundación EPIC

Enrollment

88 participants

Start Date

Oct 14, 2022

Study Type

INTERVENTIONAL

Conditions

Coronary Artery Disease

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This Spanish trial studies patients who are already taking a "polypill" called Trinomia — a single pill combining aspirin, a statin, and a blood pressure medication — for secondary prevention (reducing risk of a second heart attack or stroke). The crossover design means all participants try different formulations of the polypill to compare their effects on heart risk factors. **You may be eligible if...** - You are over 18 - You are already being prescribed the Trinomia polypill by your doctor for heart disease prevention - You are able to attend 6 study visits - You can give informed consent **You may NOT be eligible if...** - You are allergic to any component of the polypill - You are participating in another clinical trial - Your life expectancy is less than 1 year - You have a planned heart procedure (coronary revascularization) - You had a coronary stent placed in the last 12 months - You are on additional blood-thinning drugs beyond aspirin (such as heparin, anticoagulants, or P2Y12 inhibitors) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPolypill of acetylsalicylic acid, ramipril and atorvastatin

Administration of acetylsalicylic acid, ramipril and atorvastatin in a polypill during 3 months more

DRUGDrugs 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

Locations(1)

Hospital Universitario de Cabueñes

Gijón, Principality of Asturias, Spain

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NCT05030818

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