TIME ASPIRIN: Chronotherapy With Aspirin for Reduction of Cardiovascular Disease (TImE ASPIRIN)

Leiden University Medical Center (LUMC)

Status: Terminated

Conditions: Cardiovascular Diseases

Treatments: Other: aspirin after awakening + placebo before bedtime; Other: placebo after awakening + aspirin before bedtime

Study type: Interventional

Funder types: Other

Identifiers

NCT04132791

P18.127

Details and patient eligibility

About

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.

Full 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.

Enrollment: 328 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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328 participants in 2 patient groups

aspirin after awakening + placebo before bedtime

Other group

Description:

Acetylsalicylic acid 80 mg once daily, orally. Intake in de morning after awakening. Participants already use acetylsalicylic acid 80 mg once daily due to secondary prevention of cardiovascular disease. Placebo tablet once daily will be added to their medication. The placebo tablet will be taken before bedtime, orally. The placebo is given throughout the study.

Treatment:

Other: aspirin after awakening + placebo before bedtime

placebo after awakening +aspirin before bedtime

Experimental group

Description:

Acetylsalicylic acid 80 mg once daily, orally. The time will be changed form morning to bedtime. Participants already use acetylsalicylic acid 80 mg once daily due to secondary prevention of cardiovascular disease. Placebo tablet once daily will be added to their medication. The placebo tablet will be taken after awakening, orally. The placebo is given throughout the study.

Treatment:

Other: placebo after awakening + aspirin before bedtime