Recruiting

Cross-over Study of Coronary Risk Factors With a Polypill

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.

ClinicalTrials.gov IDNCT05030818

PhasePHASE4

Enrollment88

SponsorFundación EPIC

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

Coronary Artery Disease

About this study

Interventions

Drug: Polypill of acetylsalicylic acid, ramipril and atorvastatin — Administration of acetylsalicylic acid, ramipril and atorvastatin in a polypill during 3 months more
Drug: Drugs 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

Primary outcomes

LDL-cholesterol (Months 2 and 3 vs. Months 5 and 6)
Systolic blood pressure (Months 2 and 3 vs. Months 5 and 6)

Eligibility information

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.

Study locations

Hospital Universitario de Cabueñes, Gijón, Principality of Asturias 33203 Spain

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.