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Protocol: “Aspirin AM or PM?: effect on circadian rhythm of platelet reactivity”

Effects of low-dose aspirin taken at bedtime vs. on awakening on circadian rhythm of platelet function in healthy subjects

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2013-001410-16-NL
Enrollment
Unknown
Registered
2013-06-27
Start date
2013-07-01
Completion date
Unknown
Last updated
2013-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

platelet reactivity

Interventions

Trade Name: Aspirin Product Name: acetylsalicylic acid Product Code: RVG 16466 Pharmaceutical Form: Tablet

Sponsors

Netherlands Heart Foundation
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: • Healthy subject • Age >18yrs • Capacity to give informed consent (IC) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 11 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1

Exclusion criteria

Exclusion criteria: • Active chronic disease • Use of any other medication • History of: major bleeding events, cardiovascular disease, malignancy • Platelet count < 150 * 109/L • VerifyNow Aspirin Reaction Units <550 ARU • Smoking • Shift workers • Extreme chronotypes • Pregnancy

Design outcomes

Primary

MeasureTime frame
Main Objective: To study the effect of 100 mg aspirin intake at bedtime compared with 100 mg aspirin intake on awakening on circadian rhythm of platelet function in healthy subjects.;Secondary Objective: not applicable;Primary end point(s): platelet reactivity, measured by VerifyNow aspirin device;Timepoint(s) of evaluation of this end point: after 2 and 6 weeks

Secondary

MeasureTime frame
Secondary end point(s): other parameters of platelet function;Timepoint(s) of evaluation of this end point: after 2 and 6 weeks

Countries

Netherlands

Contacts

Public ContactT.N. Bonten

Leiden University Medical Center

0031715265633

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026