Randomized Comparison of Morning Versus Bedtime Administration of Aspirin: A Cardiovascular Circadian Chronotherapy (C3) Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Aspirin.
- Who it may be relevant to
- Registry conditions: Atherosclerosis, Cardiovascular Diseases, Drug Effect. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Drug Aspirin
Aspirin at currently prescribed dose
Primary outcome measures
- Composite of hospitalization for myocardial infarction, hospitalization for stroke, coronary revascularization, or cardiovascular death [Time frame: Up to 3 years]
Secondary outcome measures (5)
- Hospitalization for myocardial infarction [Time frame: Up to 3 years]
- Hospitalization for stroke [Time frame: Up to 3 years]
- Coronary revascularization [Time frame: Up to 3 years]
- Cardiovascular death [Time frame: Up to 3 years]
- All-cause death [Time frame: Up to 3 years]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Denmark · 1 center
- Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiol — Hellerup
Identifiers
NCT: NCT05932472 · ASPIRIN-C3