Coronary Artery Disease
Conditions
Keywords
Hypertension, LDL-cholesterol, Platelet inhibition
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.
Interventions
DRUGPolypill of acetylsalicylic acid, ramipril and atorvastatin
Administration of acetylsalicylic acid, ramipril and atorvastatin in a polypill during 3 months more
DRUGDrugs 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
Sponsors
Fundación EPIC
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| LDL-cholesterol | Months 2 and 3 vs. Months 5 and 6 | Mean of absolute level of LDL cholesterol |
| Systolic blood pressure | Months 2 and 3 vs. Months 5 and 6 | Mean of absolute level of systolic blood pressure |
Countries
Spain
Contacts
Primary ContactIñigo Lozano Martinez-Luengas, MD, PHD
Outcome results
None listed