Randomized Comparison of Morning Versus Bedtime Administration of Aspirin: A Cardiovascular Circadian Chronotherapy (C3) Trial (ASPIRIN-C3)

February 5, 2024 updated by: Tor Biering-Sørensen
Wide variability in the antiplatelet effects of aspirin may lead to recurrent thromboembolic events. Several pilot studies have suggested potential benefits of taking aspirin at bedtime rather than in the morning. The primary objective of this study is to examine whether aspirin administration at bedtime versus in the morning provides a superior reduction in the incidence of major adverse cardiovascular events among patients with or without established atherosclerotic cardiovascular disease, who are already taking aspirin.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The study is a pragmatic, registry-based, open-label, randomized controlled trial combining the utilization of the Danish nationwide health registries and the official Danish electronic letter system (Digital Post/eBoks) into an innovative, decentralized trial requiring no study visits from participants. The nationwide health registries will be used for identification of potential participants and data collection, including baseline information and follow-up data, while the electronic letter system will be used for sending recruitment letters and communicating with participants. Study participants will provide electronic informed consent from home before inclusion and randomization.

The trial will include patients currently in aspirin treatment regardless of the presence or absence of established cardiovascular disease. Participants will be randomized 1:1 to either aspirin administration at bedtime or in the morning. The trial is event-driven.

Study Type

Interventional

Enrollment (Estimated)

32706

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Denmark
      • Hellerup, Denmark, 2900
        • Recruiting
        • Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age >=18 years
  • Current chronic treatment with aspirin (as recorded in the Danish National Prescription Registry and confirmed by the participant via questionnaire)
  • Signed informed consent

Exclusion Criteria:

  • There are no exclusion criteria for this trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Aspirin at bedtime
Participants randomized to aspirin administration at bedtime will be instructed to take their aspirin at approx. 8PM-12AM.
Drug: Aspirin
Aspirin at currently prescribed dose
Active Comparator: Aspirin in the morning
Participants randomized to aspirin administration in the morning will be instructed to take their aspirin upon awakening or with their breakfast (approx. 6-10AM).
Drug: Aspirin
Aspirin at currently prescribed dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Composite of hospitalization for myocardial infarction, hospitalization for stroke, coronary revascularization, or cardiovascular death
Time Frame: Up to 3 years
Up to 3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
All-cause death
Time Frame: Up to 3 years
Up to 3 years
Hospitalization for myocardial infarction
Time Frame: Up to 3 years
Up to 3 years
Hospitalization for stroke
Time Frame: Up to 3 years
Up to 3 years
Coronary revascularization
Time Frame: Up to 3 years
Up to 3 years
Cardiovascular death
Time Frame: Up to 3 years
Up to 3 years

Other Outcome Measures

Outcome Measure
Time Frame
Bleeding episode requiring hospitalization
Time Frame: Up to 3 years
Up to 3 years
Hospitalization for intracranial hemorrhage
Time Frame: Up to 3 years
Up to 3 years
Hospitalization for gastrointestinal hemorrhage
Time Frame: Up to 3 years
Up to 3 years
Hospitalization for unstable angina
Time Frame: Up to 3 years
Up to 3 years
Any arterial revascularization
Time Frame: Up to 3 years
Up to 3 years
Any venous thromboembolism
Time Frame: Up to 3 years
Up to 3 years
Time of day of hospitalization for myocardial infarction
Time Frame: Up to 3 years
Up to 3 years
Time of day of hospitalization for stroke
Time Frame: Up to 3 years
Up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tor Biering-Sørensen

Investigators

  • Principal Investigator: Manan Pareek, MD, PhD, Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2024

Primary Completion (Estimated)

January 15, 2027

Study Completion (Estimated)

February 15, 2027

Study Registration Dates

First Submitted

June 22, 2023

First Submitted That Met QC Criteria

July 5, 2023

First Posted (Actual)

July 6, 2023

Study Record Updates

Last Update Posted (Estimated)

February 6, 2024

Last Update Submitted That Met QC Criteria

February 5, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ASPIRIN-C3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Baseline and endpoint data will be collected from Danish administrative health registries, which are subject to Danish legislation and can only be made available to a third party under certain conditions. Please contact the sponsor in case of any inquiries.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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