The effect of Polypill V on cardiovascular events

The effect of Polypill V on cardiovascular events in patients with breast and colorectal cancer

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20201110049329N1

Enrollment

440

Registered

2020-12-23

Start date

2021-05-21

Completion date

Unknown

Last updated

2021-01-05

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

Conditions

Condition 1: Cardiovascular events. Condition 2: Breast Cancer. Condition 3: Colorectal Cancer. Medical observation or evaluation for suspected diseases or conditions, ruled out cardiovascular diseases Carcinoma of breast, specialised type Malignant neoplasms of rectosigmoid junction, unspecified

Interventions

Intervention 1: Intervention group: The intervention is Polypill V, which includes aspirin (81 mg), valsartan (40 mg), atrostatin (20 mg) and hydrochlorothiazide (5.12 mg). This pill is produced Albo

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Study participants signed written informed consent, Cancer patients with no history of CVD, Having EF>50

Exclusion criteria

Exclusion criteria: Having Contraindications to one of the components of the polypill V

Design outcomes

Primary

Measure	Time frame
Systolic and diastolic heart failure. Timepoint: 6 months and one year after the intervention. Method of measurement: Ecocardiography.;Symptomatic arrhythmia. Timepoint: 6 months and one year after the intervention. Method of measurement: Clinical symptoms, Ecocardiography.;Acute coronary syndromes. Timepoint: 6 months and one year after the intervention. Method of measurement: Ecocardiography.;Stroke. Timepoint: 6 months and one year after the intervention. Method of measurement: Brain CT scan.;Cardiovascular mortality. Timepoint: 6 months and one year after the intervention. Method of measurement: Death certificate.	—

Measure

Time frame

Systolic and diastolic heart failure. Timepoint: 6 months and one year after the intervention. Method of measurement: Ecocardiography.;Symptomatic arrhythmia. Timepoint: 6 months and one year after the intervention. Method of measurement: Clinical symptoms, Ecocardiography.;Acute coronary syndromes. Timepoint: 6 months and one year after the intervention. Method of measurement: Ecocardiography.;Stroke. Timepoint: 6 months and one year after the intervention. Method of measurement: Brain CT scan.;Cardiovascular mortality. Timepoint: 6 months and one year after the intervention. Method of measurement: Death certificate.

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Secondary

Measure	Time frame
Changes in blood pressure. Timepoint: 6 months and one year after the intervention. Method of measurement: Digital BP monitor.;Change in lipids. Timepoint: 6 months and one year after the intervention. Method of measurement: Blood test.;Change CRP. Timepoint: 6 months and one year after the intervention. Method of measurement: Blood test.;Hospitalization for cardiac events. Timepoint: 6 months and one year after the intervention. Method of measurement: Hospitalization file.;Quality of life. Timepoint: 6 months and one year after the intervention. Method of measurement: WHO Questionnaire.;Echocardiographic changes. Timepoint: 6 months and one year after the intervention. Method of measurement: Echocardiography.	—

Measure

Time frame

Changes in blood pressure. Timepoint: 6 months and one year after the intervention. Method of measurement: Digital BP monitor.;Change in lipids. Timepoint: 6 months and one year after the intervention. Method of measurement: Blood test.;Change CRP. Timepoint: 6 months and one year after the intervention. Method of measurement: Blood test.;Hospitalization for cardiac events. Timepoint: 6 months and one year after the intervention. Method of measurement: Hospitalization file.;Quality of life. Timepoint: 6 months and one year after the intervention. Method of measurement: WHO Questionnaire.;Echocardiographic changes. Timepoint: 6 months and one year after the intervention. Method of measurement: Echocardiography.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Nizal Sarrafzadegan

Esfahan University of Medical Sciences

nsarrafzadegan@gmail.com+98 31 3611 5313

Outcome results

None listed

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