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Clinical Trials in Spain / NCT05030818
Recruiting Phase 4

Cross-over Study of Coronary Risk Factors With a Polypill

NCT05030818 · tracked via the Priya Life Science Spain tracker
Sponsor
Fundación EPIC
Phase
Phase 4
Started
2022-10-14
Last updated
2025-08-05

Condition(s) studied

Coronary Artery Disease

Investigational drug(s) / intervention(s)

Polypill of acetylsalicylic acid, ramipril and atorvastatinDrugs taken separately: acetylsalicylic acid, ramipril and atorvastatin

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

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

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Hospital Universitario de Cabueñes Gijón Principality of Asturias Recruiting

More Fundación EPIC trials in Spain

Parenteral Antiplatelet Agents in Real-world Spanish PCI Patients Active, not recruiting
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PREVAIL Paclitaxel-coated Balloon in Small Coronary Disease and High-bleeding Risk Patients Active, not recruiting
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Comparison of Allegra vs Sapien Transcatheter Aortic Valves in Valve-In-Valve Indication Recruiting

Other trials for the same condition

First in Men Study: BIOMAG-I Active, not recruiting
PREVAIL Paclitaxel-coated Balloon in Small Coronary Disease and High-bleeding Risk Patients Active, not recruiting
Sequent Extended Study Active, not recruiting
Ischemic and Bleeding Outcomes After Angiolite Stent Implantation and an Abbreviated Dual Antiplatelet Therapy Active, not recruiting
Intracoronary Stenting and Restenosis - Randomized Trial of Drug-eluting Stent Implantation or Drug-coated Balloon Angioplasty According to Neointima Morphology in Drug-eluting Stent Restenosis 5 Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05030818 on ClinicalTrials.gov ↗ ← All trials in Spain