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

Cardiovascular Diseases Clinical Trial

— ASPIRIN-C3  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05932472
• Other study ID #: ASPIRIN-C3
• Status: Recruiting
• Phase: Phase 4
• Start date: January 15, 2024
• Est. completion date: February 15, 2027

Study information

• Verified date: February 2024
• Source: Herlev and Gentofte Hospital
• Contact: Niklas Dyrby Johansen, MD
• Phone: +4520204794
• Email: niklas.dyrby.johansen[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32706
• Est. completion date: February 15, 2027
• Est. primary completion date: January 15, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atherosclerosis
• Cardiovascular Diseases
• Drug Effect

Intervention

Drug:
• Aspirin
Aspirin at currently prescribed dose

Locations

Country	Name	City	State
Denmark	Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte	Hellerup

Sponsors (1)

Lead Sponsor	Collaborator
Tor Biering-Sørensen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Bleeding episode requiring hospitalization		Up to 3 years
Other	Hospitalization for intracranial hemorrhage		Up to 3 years
Other	Hospitalization for gastrointestinal hemorrhage		Up to 3 years
Other	Hospitalization for unstable angina		Up to 3 years
Other	Any arterial revascularization		Up to 3 years
Other	Any venous thromboembolism		Up to 3 years
Other	Time of day of hospitalization for myocardial infarction		Up to 3 years
Other	Time of day of hospitalization for stroke		Up to 3 years
Primary	Composite of hospitalization for myocardial infarction, hospitalization for stroke, coronary revascularization, or cardiovascular death		Up to 3 years
Secondary	Hospitalization for myocardial infarction		Up to 3 years
Secondary	Hospitalization for stroke		Up to 3 years
Secondary	Coronary revascularization		Up to 3 years
Secondary	Cardiovascular death		Up to 3 years
Secondary	All-cause death		Up to 3 years