Coronary Artery Disease Clinical Trial
— POLICROSSOfficial title:
Cross-over Analysis of the Control of Coronary Risk Factors and Level of Platelet Inhibition 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.
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. |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Universitario de Cabueñes | Gijón | Asturias |
Lead Sponsor | Collaborator |
---|---|
Fundación para la Investigación Biosanitaria del Principado de Asturias |
Spain,
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
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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