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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05030818
Other study ID # POLICROSS
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date October 14, 2022
Est. completion date September 30, 2023

Study information

Verified date November 2022
Source Fundación para la Investigación Biosanitaria del Principado de Asturias
Contact Iñigo Lozano Martinez-Luengas, MD, PHD
Phone +34630901145
Email inigo.lozano@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

The European Society of Cardiology indicates that reducing the frequency of administration is the most effective measure to improve therapeutic adherence. Current guidelines recommend with class I and level of evidence A the use of polypills. A polypill, composed of 100 mg of acetylsalicylic acid and variable doses of atorvastatin and ramipril, is approved for secondary prevention of cardiovascular disease and has also been widely used in primary prevention. Numerous studies have been carried out focusing on different designs of polypill in cardiovascular prevention to study their efficacy, cost-effectiveness and administration schedule. Specifically, that polypill already has an extensive literature. However, although there are previous studies with a cross-over design with other types of polypill to assess the effects on the control of arterial hypertension and LDL cholesterol, to date there has never been a cross-over design study with the polypill compared to the administration of its components separately in the control of blood pressure, lipid level and level of platelet aggregation. Patients will be randomized to polypill vs separate components. Each patient will receive a follow-up visit per month for 6 months, of which will be 3 consecutive months with treatment with the polypill in its corresponding dose and the remaining 3 months with the same drugs separately. Primary objectives: Systolic blood pressure level and LDL cholesterol. Secondary objectives: Degree of platelet aggregation with thromboxane A2 kit, diastolic blood pressure level, total cholesterol and HDL, level of patient satisfaction, degree of adherence to treatment, adverse events.


Recruitment information / eligibility

Status Recruiting
Enrollment 88
Est. completion date September 30, 2023
Est. primary completion date June 30, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
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

Locations

Country Name City State
Spain Hospital Universitario de Cabueñes Gijón Asturias

Sponsors (1)

Lead Sponsor Collaborator
Fundación para la Investigación Biosanitaria del Principado de Asturias

Country where clinical trial is conducted

Spain, 

References & Publications (5)

Castellano JM, Sanz G, Peñalvo JL, Bansilal S, Fernández-Ortiz A, Alvarez L, Guzmán L, Linares JC, García F, D'Aniello F, Arnáiz JA, Varea S, Martínez F, Lorenzatti A, Imaz I, Sánchez-Gómez LM, Roncaglioni MC, Baviera M, Smith SC Jr, Taubert K, Pocock S, — View Citation

Castellano JM, Verdejo J, Ocampo S, Rios MM, Gómez-Álvarez E, Borrayo G, Ruiz E, Ibáñez B, Fuster V; SORS investigators. Clinical Effectiveness of the Cardiovascular Polypill in a Real-Life Setting in Patients with Cardiovascular Risk: The SORS Study. Arc — View Citation

González-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. Ep — View Citation

Marzal D, Rodríguez Padial L, Arnáiz JA, Castro A, Cosín 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. — View Citation

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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary LDL-cholesterol Mean of absolute level of LDL cholesterol Months 2 and 3 vs. Months 5 and 6
Primary Systolic blood pressure Mean of absolute level of systolic blood pressure Months 2 and 3 vs. Months 5 and 6
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