Actively Recruiting

Phase 4
Age: 18Years +
All Genders
NCT05030818

Cross-over Study of Coronary Risk Factors With a Polypill

Led by Fundación EPIC · Updated on 2025-08-05

88

Participants Needed

1

Research Sites

184 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Cross-over Study of Coronary Risk Factors With a Polypill

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients over 18 years of age
  • Patients currently treated with the Trinomia® polypill for secondary prevention
  • Ability to attend six study visits over the six-month period
  • Signed Informed Consent form
Not Eligible

You will not qualify if you...

  • Patients who do not sign the informed consent
  • Inability to understand and follow the study protocol
  • Contraindication to any component of the polypill
  • Participation in another clinical trial
  • Any condition limiting life expectancy to less than 1 year
  • Scheduled coronary revascularization
  • Coronary stent implantation within the last 12 months
  • Treatment with antithrombotic drugs other than acetylsalicylic acid such as low molecular weight heparin, P2Y12 receptor inhibitors, or oral anticoagulants

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Hospital Universitario de Cabueñes

Gijón, Principality of Asturias, Spain, 33203

Actively Recruiting

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Research Team

I

Iñigo Lozano Martinez-Luengas, MD, PHD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

PREVENTION

Number of Arms

2

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