TIME ASPIRIN: Chronotherapy With Aspirin for Reduction of Cardiovascular Disease

Cardiovascular Diseases Clinical Trial

— TImE ASPIRIN  

Official title:

Chronotherapy With Aspirin for Reduction of Cardiovascular Disease

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04132791
• Other study ID #: P18.127
• Status: Terminated
• Phase: N/A
• Start date: October 7, 2019
• Est. completion date: March 31, 2022

Study information

• Verified date: June 2022
• Source: Leiden University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Aspirin is the cornerstone of preventive cardiovascular disease (CVD) treatment and bedtime intake of aspirin (chronotherapy) has been shown to reduce morning activity of platelets. It has been shown that platelet reactivity follows a clear circadian rhythm, with a peak of platelet reactivity during the morning (6-12 AM). Importantly, studies have shown in meta-analyses that high platelet activity is predictive of adverse cardiovascular outcomes in patients with stable CVD. Given this knowledge, it is highly likely that the morning peak of platelet reactivity contributes to the morning peak of cardiovascular events and that reduction of morning platelet activity prevents cardiovascular events during morning hours. This may be achieved by intake of aspirin at bedtime instead of on awakening. 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Other:
• placebo after awakening + aspirin before bedtime
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 wakening and aspirin before bedtime.
• aspirin after awakening + placebo before bedtime
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 wakening and aspirin before bedtime.

Locations

Country	Name	City	State
Netherlands	Leiden University Medical Center	Leiden	Zuid-Holland

Sponsors (2)

Lead Sponsor	Collaborator
Leiden University Medical Center	ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

Outcome

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