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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorTor Biering-Sørensen

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

There are no exclusion criteria for this trial

Trial design

Design model

Parallel

Treatments tested in this trial

  • Aspirin

    Drug

    Aspirin at currently prescribed dose

Treatment groups

32,706 Participants
are divided into 2 treatment groups
Group A: Aspirin at bedtimeExperimental treatment 1 intervention
Group B: Aspirin in the morningActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Composite of hospitalization for myocardial infarction, hospitalization for stroke, coronary revascularization, or cardiovascular death

Time frame
Up to 3 years

Secondary outcomes

1

Hospitalization for myocardial infarction

Time frame
Up to 3 years
2

Hospitalization for stroke

Time frame
Up to 3 years
3

Coronary revascularization

Time frame
Up to 3 years
4

Cardiovascular death

Time frame
Up to 3 years

Other outcomes

1

Bleeding episode requiring hospitalization

Time frame
Up to 3 years
2

Hospitalization for intracranial hemorrhage

Time frame
Up to 3 years
3

Hospitalization for gastrointestinal hemorrhage

Time frame
Up to 3 years
4

Hospitalization for unstable angina

Time frame
Up to 3 years

Sponsors and contacts

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Tor Biering-Sørensen

Lead sponsor

Herlev and Gentofte Hospital

Sponsor institution