Cross-over Study of Coronary Risk Factors With a Polypill

NCT05030818 | Recruiting Phase 4 DMC

• 1 other identifier: POLICROSS
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

Hypertension; LDL-cholesterol; Platelet inhibition

Outcome Measures

Primary Outcomes (2)

• LDL-cholesterol

  Mean of absolute level of LDL cholesterol

  Months 2 and 3 vs. Months 5 and 6

• Systolic blood pressure

  Mean of absolute level of systolic blood pressure

  Months 2 and 3 vs. Months 5 and 6

Study Arms (2)

Polypill

EXPERIMENTAL

Patients will be receiving the polypill at the adequate doses during 3 months

Drug: Drugs taken separately: acetylsalicylic acid, ramipril and atorvastatin

Drugs taken separately

ACTIVE COMPARATOR

Patients will be receiving during 3 months the same components and at the same doses than with the polypill

Drug: Polypill of acetylsalicylic acid, ramipril and atorvastatin

Interventions

Polypill of acetylsalicylic acid, ramipril and atorvastatin DRUG

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

Drugs taken separately

Drugs taken separately: acetylsalicylic acid, ramipril and atorvastatin DRUG

Patients will be receiving during 3 months more the same components acetylsalicylic acid, ramipril and atorvastatin than with the polypill

Polypill

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundación EPIC: lead

Study Sites (1)

Hospital Universitario de Cabueñes

Gijón, Principality of Asturias, 33203, Spain

RECRUITING

Related Publications (5)

• Tamargo J, Castellano JM, Fuster V. The Fuster-CNIC-Ferrer Cardiovascular Polypill: a polypill for secondary cardiovascular prevention. Int J Cardiol. 2015 Dec;201 Suppl 1:S15-22. doi: 10.1016/S0167-5273(15)31028-7.

  PMID: 26747390 RESULT

• Castellano JM, Sanz G, Penalvo JL, Bansilal S, Fernandez-Ortiz A, Alvarez L, Guzman L, Linares JC, Garcia F, D'Aniello F, Arnaiz JA, Varea S, Martinez F, Lorenzatti A, Imaz I, Sanchez-Gomez LM, Roncaglioni MC, Baviera M, Smith SC Jr, Taubert K, Pocock S, Brotons C, Farkouh ME, Fuster V. A polypill strategy to improve adherence: results from the FOCUS project. J Am Coll Cardiol. 2014 Nov 18-25;64(20):2071-82. doi: 10.1016/j.jacc.2014.08.021. Epub 2014 Sep 1.

  PMID: 25193393 RESULT

• Castellano JM, Verdejo J, Ocampo S, Rios MM, Gomez-Alvarez E, Borrayo G, Ruiz E, Ibanez B, Fuster V; SORS investigators. Clinical Effectiveness of the Cardiovascular Polypill in a Real-Life Setting in Patients with Cardiovascular Risk: The SORS Study. Arch Med Res. 2019 Jan;50(1):31-40. doi: 10.1016/j.arcmed.2019.04.001. Epub 2019 Apr 19.

  PMID: 31101241 RESULT

• Gonzalez-Juanatey JR, Tamargo J, Torres F, Weisser B, Oudovenko N. Pharmacodynamic study of the cardiovascular polypill. Is there any interaction among the monocomponents? Rev Esp Cardiol (Engl Ed). 2021 Jan;74(1):51-58. doi: 10.1016/j.rec.2019.11.008. Epub 2020 Jan 23. English, Spanish.

  PMID: 31983653 RESULT

• Marzal D, Rodriguez Padial L, Arnaiz JA, Castro A, Cosin J, Lekuona I, Guijarro C. Use of the cardiovascular polypill 40mg in secondary cardiovascular prevention. Clin Investig Arterioscler. 2018 Sep-Oct;30(5):240-247. doi: 10.1016/j.arteri.2018.04.004. Epub 2018 Jul 17. English, Spanish.

  PMID: 30017176 RESULT

MeSH Terms

Conditions

Coronary Artery Disease; Hypertension

Interventions

Ramipril; Atorvastatin

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Iñigo Lozano, MD, PHD

  Hospital de Cabueñes, Gijon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Iñigo Lozano Martinez-Luengas, MD, PHD

CONTACT

+34630901145; inigo.lozano@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Each patient will be treated (Randomized) during 3 months with the polypill acetylsalicylic acid, ramipril and atorvastatin) and another 3 months with the same drugs and at the same doses than the polypill

Study Record Dates

• First Submitted: August 30, 2021
• First Posted: September 1, 2021
• Study Start: October 14, 2022
• Primary Completion: March 30, 2026
• Study Completion: April 30, 2026
• Last Updated: August 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)