TIME ASPIRIN: Chronotherapy With Aspirin for Reduction of Cardiovascular Disease

NCT ID: NCT04132791

Last Updated: 2022-06-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 328 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-07
• Study Completion Date: 2022-03-31

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.

Conditions

Cardiovascular Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

aspirin after awakening + placebo before bedtime

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.

Group Type: OTHER

aspirin after awakening + placebo before bedtime

Intervention Type: OTHER

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.

placebo after awakening +aspirin before bedtime

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.

Group Type: EXPERIMENTAL

placebo after awakening + aspirin before bedtime

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

Other Intervention Names

Acetylsalicylic acid Cardio Teva 80 mg, intake before bedtime; Acetylsalicylic acid Cardio Teva 80 mg, intake after awakening

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ZonMw: The Netherlands Organisation for Health Research and Development

OTHER

Sponsor Role: collaborator

Leiden University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

tnbonten

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tobias Bonten

Role: PRINCIPAL_INVESTIGATOR

Leiden University

Locations

Leiden University Medical Center

Leiden, South Holland, Netherlands

Countries

Netherlands

Other Identifiers

P18.127

Identifier Type: -

Identifier Source: org_study_id