Clinical trial NCT05932472: Randomized Comparison of Morning Versus Bedtime Administration of Aspirin: A Cardiovascular Circadian Chronotherapy (C3) Trial
Official title: Randomized Comparison of Morning Versus Bedtime Administration of Aspirin: A Cardiovascular Circadian Chronotherapy (C3) Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Atherosclerosis
Cardiovascular Diseases
Drug Effect
Keywords: Aspirin
Cardiovascular Disease
Prevention
Circadian Rhythm
Randomized Controlled Trial
Pragmatic
Outcomes
Lead sponsor: Herlev and Gentofte Hospital
Sponsor class: OTHER
First posted: 2023-07-06
Enrollment: 32706
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Composite of hospitalization for myocardial infarction, hospitalization for stroke, coronary revascularization, or cardiovascular death
timeFrame: Up to 3 years
Secondary outcomes:
measure: Hospitalization for myocardial infarction
timeFrame: Up to 3 years
measure: Hospitalization for stroke
timeFrame: Up to 3 years
measure: Coronary revascularization
timeFrame: Up to 3 years
measure: Cardiovascular death
timeFrame: Up to 3 years
measure: All-cause death
timeFrame: Up to 3 years
Other outcomes:
measure: Bleeding episode requiring hospitalization
timeFrame: Up to 3 years
measure: Hospitalization for intracranial hemorrhage
timeFrame: Up to 3 years
measure: Hospitalization for gastrointestinal hemorrhage
timeFrame: Up to 3 years
measure: Hospitalization for unstable angina
timeFrame: Up to 3 years
measure: Any arterial revascularization
timeFrame: Up to 3 years
measure: Any venous thromboembolism
timeFrame: Up to 3 years
measure: Time of day of hospitalization for myocardial infarction
timeFrame: Up to 3 years
measure: Time of day of hospitalization for stroke
timeFrame: Up to 3 years
Locations:
city: Hellerup
country: Denmark
facility: Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte
Study officials:
affiliation: Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte
name: Manan Pareek, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: