CROSS-OVER ANALYSIS OF THE CONTROL OF RISK FACTORS AND ANTIAGGREGATION WITH POLIPILL (POLICROSS TRIAL)

CROSS-OVER ANALYSIS OF THE CONTROL OF RISK FACTORS AND ANTIAGGREGATION WITH POLIPILL (POLICROSS TRIAL) - POLICROSS TRIAL

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-000982-33-ES

Enrollment

Registered

2022-02-11

Start date

2022-04-19

Completion date

Unknown

Last updated

2022-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Degree of control coronary risk factors and platelet aggregation MedDRA version: 20.0 Level: PT Classification code 10051592 Term: Acute coronary syndrome System Organ Class: 10007541 - Cardiac disorders

Interventions

Trade Name: TRINOMIA 100 mg/20 mg/10 mg Pharmaceutical Form: Capsule, hard INN or Proposed INN: RAMIPRIL CAS Number: 87333-19-5 Concentration unit: mg milligram(s) Concentration type: equal Concentrat

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

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

Secondary

Measure	Time frame
Secondary end point(s): 2 months and 3 months versus 5 months and 6 months;Timepoint(s) of evaluation of this end point: 2 months and 3 months versus 5 months and 6 months	—

Primary

Measure	Time frame
Main Objective: To analyze 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 Trinomia® polypill and another of 3 months with the components separately.;Secondary Objective: Total cholesterol and HDL. Diastolic blood pressure level. Patient satisfaction level. Degree of adherence to treatment. Platelet aggregation degree with thromboxane A2 kit. Adverse events.;Primary end point(s): Systolic blood pressure level. LDL cholesterol.;Timepoint(s) of evaluation of this end point: 2 months and 3 months versus 5 months and 6 months	—

Measure

Time frame

Main Objective: To analyze 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 Trinomia® polypill and another of 3 months with the components separately.;Secondary Objective: Total cholesterol and HDL. Diastolic blood pressure level. Patient satisfaction level. Degree of adherence to treatment. Platelet aggregation degree with thromboxane A2 kit. Adverse events.;Primary end point(s): Systolic blood pressure level. LDL cholesterol.;Timepoint(s) of evaluation of this end point: 2 months and 3 months versus 5 months and 6 months

—

Countries

Spain

Contacts

Public ContactIÑIGO LOZANO

Fundación para la Investigación y la Innovación Biosanitaria de Asturias

inigo.lozano@gmail.com0034985 10 99 05

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026