CROSS-OVER ANALYSIS OF THE CONTROL OF RISK FACTORS AND ANTIAGGREGATION WITH POLIPILL (POLICROSS TRIAL)
- Conditions
- Degree of control coronary risk factors and platelet aggregationMedDRA version: 20.0Level: PTClassification code 10051592Term: Acute coronary syndromeSystem Organ Class: 10007541 - Cardiac disordersTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2021-000982-33-ES
- Lead Sponsor
- Fundación para la Investigación y la Innovación Biosanitaria de Asturias
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 88
Patients over 18 years of age.
Patients with ischemic heart disease under treatment with the Trinomia® polypill in any of its presentations for secondary prevention and who can make the 6 visits necessary to complete the study.
Patients who sign the Informed Consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 44
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 44
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
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method