NCT05932472

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32,706

participants targeted

Target at P75+ for phase_4

Timeline
10mo left

Started Jan 2024

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress75%
Jan 2024Feb 2027

First Submitted

Initial submission to the registry

June 22, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 6, 2023

Completed
6 months until next milestone

Study Start

First participant enrolled

January 15, 2024

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2027

Last Updated

February 6, 2024

Status Verified

February 1, 2024

Enrollment Period

3 years

First QC Date

June 22, 2023

Last Update Submit

February 5, 2024

Conditions

AtherosclerosisCardiovascular DiseasesDrug Effect

Keywords

AspirinCardiovascular DiseasePreventionCircadian RhythmRandomized Controlled TrialPragmaticOutcomes

Outcome Measures

Primary Outcomes (1)

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

    Up to 3 years

Secondary Outcomes (5)

  • Hospitalization for myocardial infarction

    Up to 3 years

  • Hospitalization for stroke

    Up to 3 years

  • Coronary revascularization

    Up to 3 years

  • Cardiovascular death

    Up to 3 years

  • All-cause death

    Up to 3 years

Other Outcomes (8)

  • Bleeding episode requiring hospitalization

    Up to 3 years

  • Hospitalization for intracranial hemorrhage

    Up to 3 years

  • Hospitalization for gastrointestinal hemorrhage

    Up to 3 years

  • +5 more other outcomes

Study Arms (2)

Aspirin at bedtime

EXPERIMENTAL

Participants randomized to aspirin administration at bedtime will be instructed to take their aspirin at approx. 8PM-12AM.

Drug: Aspirin

Aspirin in the morning

ACTIVE COMPARATOR

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

Interventions

AspirinDRUG

Aspirin at currently prescribed dose

Aspirin at bedtimeAspirin in the morning

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte

Hellerup, 2900, Denmark

RECRUITING

MeSH Terms

Conditions

AtherosclerosisCardiovascular Diseases

Interventions

Aspirin

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Manan Pareek, MD, PhD

    Center for Translational Cardiology and Pragmatic Randomized Trials, Department of Cardiology, Copenhagen University Hospital - Herlev and Gentofte

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Niklas Dyrby Johansen, MD

CONTACT

+4520204794niklas.dyrby.johansen@regionh.dk

Manan Pareek, MD, PhD

CONTACT

+4525536900mananpareek@dadlnet.dk

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor, MD, MSc, MPH, PhD

Study Record Dates

First Submitted

June 22, 2023

First Posted

July 6, 2023

Study Start

January 15, 2024

Primary Completion (Estimated)

January 15, 2027

Study Completion (Estimated)

February 15, 2027

Last Updated

February 6, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will share

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.

Locations

DK(1)