TIME ASPIRIN: Chronotherapy With Aspirin for Reduction of Cardiovascular Disease

NCT04132791 | Terminated

• 1 other identifier: P18.127
• Study Type: interventional
• Target: 328
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases

Keywords

Aspirin; Chronotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Comparing the incidence rate of major cardiovascular events between the two groups in the morning (6-12), evening (12-21) and night (21-6).

  maximum of 4 years follow up

• Incidence rate of side-effects between the 2 groups

  maximum of 4 years follow up

• cost-effectiveness of the intervention

  maximum of 4 years follow up

Other Outcomes (1)

• difference in quality of life

  maximum of 4 years follow up

Study Arms (2)

aspirin after awakening + placebo before bedtime

OTHER

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.

Other: aspirin after awakening + placebo before bedtime

placebo after awakening +aspirin before bedtime

EXPERIMENTAL

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.

Other: placebo after awakening + aspirin before bedtime

Interventions

placebo after awakening + aspirin before bedtime 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.

Also known as: Acetylsalicylic acid Cardio Teva 80 mg, intake before bedtime

placebo after awakening +aspirin before bedtime

aspirin after awakening + placebo before bedtime 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.

Also known as: Acetylsalicylic acid Cardio Teva 80 mg, intake after awakening

aspirin after awakening + placebo before bedtime

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Pregnancy
• Mental or physical disability to fulfil study requirements
• Insufficient knowledge of the Dutch language
• Patients currently participating in another (clinical) trial or study

Sponsors & Collaborators

• Leiden University Medical Center: lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator

Study Sites (1)

Leiden University Medical Center

Leiden, South Holland, 2333 ZA, Netherlands

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Tobias Bonten

  Leiden University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: parallel double blinded placebo controlled randomized clinical trial design

Study Record Dates

• First Submitted: June 7, 2019
• First Posted: October 21, 2019
• Study Start: October 7, 2019
• Primary Completion: March 31, 2022
• Study Completion: March 31, 2022
• Last Updated: June 24, 2022

Record last verified: 2022-06

Locations

NL (1)