Clinical trial NCT04132791: TIME ASPIRIN: Chronotherapy With Aspirin for Reduction of Cardiovascular Disease
Official title: Chronotherapy With Aspirin for Reduction of Cardiovascular Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cardiovascular Diseases
Keywords: Aspirin
Chronotherapy
Lead sponsor: Leiden University Medical Center
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2019-10-21
Enrollment: 328
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: parallel double blinded placebo controlled randomized clinical trial design
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence rate of major adverse cardiovascular events
timeFrame: maximum of 4 years follow up
Secondary outcomes:
measure: Comparing the incidence rate of major cardiovascular events between the two groups in the morning (6-12), evening (12-21) and night (21-6).
timeFrame: maximum of 4 years follow up
measure: Incidence rate of side-effects between the 2 groups
timeFrame: maximum of 4 years follow up
measure: cost-effectiveness of the intervention
timeFrame: maximum of 4 years follow up
Other outcomes:
measure: difference in quality of life
timeFrame: maximum of 4 years follow up
Locations:
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
state: Zuid-Holland
Study officials:
affiliation: Leiden University
name: Tobias Bonten
role: PRINCIPAL_INVESTIGATOR
References: