Determining the effect of Polypill V on cardiovascular events in patients with breast and colorectal cancer
Design
Two arm parallel group randomised clinical trial with Stratification randomization.
Settings and conduct
This study is a parallel randomized controlled clinical trial that is performed in patients with breast and colorectal cancer who have recently undergone surgery or take two sessions of cancer treatment without history of CVD in Isfahan. After coordination with oncologists, patients are referred to the research institute, then electrocardiography, echocardiography and blood tests are performed for them and a questionnaire is completed. Statistical analysis using descriptive statistics and T-test, Anova, COX regression and Kaplan Mayer survival analysis also performs extended cox if necessary.
Participants/Inclusion and exclusion criteria
Inclusion criteria :
Study participants signed written informed consent
Cancer patients with no history of CVD
Having EF>50
Exclusion criteria:
Having Contraindications to one of the components of the polypill V
Intervention groups
Patients with breast cancer and colorectal cancer
Main outcome variables
Incidence of heart failure (systolic or diastolic)
Incidence of symptomatic arrhythmia
Incidence of acute coronary artery syndromes
Incidence of stroke
Death due to cardiac events
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201110049329N1
Registration date:2020-12-23, 1399/10/03
Registration timing:prospective
Last update:2020-12-23, 1399/10/03
Update count:0
Registration date
2020-12-23, 1399/10/03
Registrant information
Name
zamaneh vafaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3611 5101
Email address
zamane.vafaei@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-21, 1400/02/31
Expected recruitment end date
2025-05-21, 1404/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Polypill V on cardiovascular events in patients with breast and colorectal cancer
Public title
The effect of Polypill V on cardiovascular events
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Study participants signed written informed consent, Cancer patients with no history of CVD, Having EF>50
Exclusion criteria:
Having Contraindications to one of the components of the polypill V
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
440
Randomization (investigator's opinion)
Randomized
Randomization description
Stratified randomization is used for random allocation of
patients. In breast cancer patients have three stratum : 1- The group that take anthracycline alone (60%) in which 78 people take drug and 78 people take usual care, 2- The group that take anthracycline and bevacizumab (20%) In this group, 26 people take drug and 26 people take usual care. 3 - The group that does not take anthracycline (20%) In this group, 26 people take drug and 26 people take usual care. In colon cancer patients have two stratum : 1 - Group that take chemotherapy (80%) In this group, 72 people take drug and 72 usual care. 2- Group that only undergoes surgery (20%) In this group, 18 people take drug and 18 people take usual care. Randomization is done using randomization software, the output of the software is from number 1 to 440, which indicates that each person who in the study in each stratum is in drug group or usual care. After the patient enrollment, according to list, patient take polypill V.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice-Chancellor in Research Affairs-Medical University
Street address
Floor 2, Bleeding No.4, Isfahan University of M Hezarjerib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2020-08-09, 1399/05/19
Ethics committee reference number
IR.MUI.MED.REC.1399.383
Health conditions studied
1
Description of health condition studied
Cardiovascular events
ICD-10 code
QA02
ICD-10 code description
Medical observation or evaluation for suspected diseases or conditions, ruled out cardiovascular diseases
2
Description of health condition studied
Breast Cancer
ICD-10 code
2C60
ICD-10 code description
Carcinoma of breast, specialised type
3
Description of health condition studied
Colorectal Cancer
ICD-10 code
2B91.Z
ICD-10 code description
Malignant neoplasms of rectosigmoid junction, unspecified
Primary outcomes
1
Description
Systolic and diastolic heart failure
Timepoint
6 months and one year after the intervention
Method of measurement
Ecocardiography
2
Description
Symptomatic arrhythmia
Timepoint
6 months and one year after the intervention
Method of measurement
Clinical symptoms, Ecocardiography
3
Description
Acute coronary syndromes
Timepoint
6 months and one year after the intervention
Method of measurement
Ecocardiography
4
Description
Stroke
Timepoint
6 months and one year after the intervention
Method of measurement
Brain CT scan
5
Description
Cardiovascular mortality
Timepoint
6 months and one year after the intervention
Method of measurement
Death certificate
Secondary outcomes
1
Description
Echocardiographic changes
Timepoint
6 months and one year after the intervention
Method of measurement
Echocardiography
2
Description
Changes in blood pressure
Timepoint
6 months and one year after the intervention
Method of measurement
Digital BP monitor
3
Description
Change in lipids
Timepoint
6 months and one year after the intervention
Method of measurement
Blood test
4
Description
Change CRP
Timepoint
6 months and one year after the intervention
Method of measurement
Blood test
5
Description
Hospitalization for cardiac events
Timepoint
6 months and one year after the intervention
Method of measurement
Hospitalization file
6
Description
Quality of life
Timepoint
6 months and one year after the intervention
Method of measurement
WHO Questionnaire
Intervention groups
1
Description
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 Alborzl Company and is taken once a day after dinner.
Category
Treatment - Drugs
2
Description
Control group: patients are followed for cardiovascular events