Cardiovascular Diseases Clinical Trial
— TImE ASPIRINOfficial title:
Chronotherapy With Aspirin for Reduction of Cardiovascular Disease
NCT number | NCT04132791 |
Other study ID # | P18.127 |
Secondary ID | |
Status | Terminated |
Phase | N/A |
First received | |
Last updated | |
Start date | October 7, 2019 |
Est. completion date | March 31, 2022 |
Verified date | June 2022 |
Source | Leiden University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will be a comparative effectiveness research to determine the difference in major adverse cardiovascular events between the group with aspirin after awakening and placebo before bedtime and the group with placebo after awakening and aspirin before bedtime.
Status | Terminated |
Enrollment | 328 |
Est. completion date | March 31, 2022 |
Est. primary completion date | March 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Use of low-dose aspirin (acetylsalicylic acid 80mg [brand name: acetylsalicylic acid cardio TEVA]~) - Patients using aspirin from an MDD ('Baxter') - Capacity to give informed consent (IC) Exclusion Criteria: - Pregnancy - Mental or physical disability to fulfil study requirements - Insufficient knowledge of the Dutch language - Patients currently participating in another (clinical) trial or study |
Country | Name | City | State |
---|---|---|---|
Netherlands | Leiden University Medical Center | Leiden | Zuid-Holland |
Lead Sponsor | Collaborator |
---|---|
Leiden University Medical Center | ZonMw: The Netherlands Organisation for Health Research and Development |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | difference in quality of life | Health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Rated level per dimensions can be coded as a number 1-5, which indicates having no problems for 1 and having extreme problems for 5. We can define 3,125 (=55) different health states. We compare the average health status of the groups at the beginning and at the end of the study. See if there is a difference in health status/ quaulity of life between the two groups. | maximum of 4 years follow up | |
Primary | Incidence rate of major adverse cardiovascular events | the difference in number of participants with a major adverse cardiovascular events, defined as the composite of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke, transient ischemic attack, need for repeat revascularízation by redo-CABG or repeat percutaneous intervention. | maximum of 4 years follow up | |
Secondary | Comparing the incidence rate of major cardiovascular events between the two groups in the morning (6-12), evening (12-21) and night (21-6). | It is expected that bedtime aspirin reduces the number of participants with primary outcome (major cardiovascular events) more during morning hours (6-12h) compared with the rest of the day. So we will compare the mornig events, afternoon/evening and night events between the two groups and compare the difference. | maximum of 4 years follow up | |
Secondary | Incidence rate of side-effects between the 2 groups | the difference between the 2 groups of the number of participants that experience side-effects (e.g. bleeding, gastrointestinal symptoms) | maximum of 4 years follow up | |
Secondary | cost-effectiveness of the intervention | Comparing the relative costs and outcomes (effects) between the 2 groups. Data from questionnaire (use of health care) and data from the primary and secondary health care systems. We can compare the use of health care between the two groups en we can calculate the difference in cost between the two groups. So we can estimate if our intervention is cost-effective. | maximum of 4 years follow up |
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