Clinical trial NCT05030818: Cross-over Study of Coronary Risk Factors With a Polypill
Official title: Cross-over Analysis of the Control of Coronary Risk Factors and Level of Platelet Inhibition With a Polypill
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Coronary Artery Disease
Keywords: Hypertension
LDL-cholesterol
Platelet inhibition
Lead sponsor: Fundación EPIC
Sponsor class: OTHER
First posted: 2021-09-01
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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
Primary purpose: PREVENTION

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.

Detailed 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.

Eligibility criteria: 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 outcomes:
measure: LDL-cholesterol
timeFrame: Months 2 and 3 vs. Months 5 and 6
measure: Systolic blood pressure
timeFrame: Months 2 and 3 vs. Months 5 and 6
Secondary outcomes:
Other outcomes:
Locations:
city: Gijón
country: Spain
facility: Hospital Universitario de Cabueñes
state: Asturias
Study officials:
affiliation: Hospital de Cabueñes, Gijon
name: Iñigo Lozano, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.