Aspirin AM or PM: Effect on Circadian Rhythm of Platelet Reactivity

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2014-01-31

Brief Summary

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Low-dose aspirin is a cornerstone in the secondary prevention of cardiovascular disease (CVD) and is usually taken on awakening, although evidence regarding optimal time of intake is lacking. Platelet reactivity follows a circadian rhythm, with a peak in the morning, contributing to the morning peak of cardiovascular disease. Due to its short half life, aspirin only inhibits platelets which are present at the time of intake. Thus, the timing of aspirin intake may influence its inhibitory effect on platelets and intake of aspirin at bedtime may attenuate the morning peak of platelet reactivity. The time-dependent effect of aspirin on circadian rhythm of platelet function has never been studied before. We hypothesize that aspirin intake at bedtime compared with intake on awakening results in a reduction of the morning peak in platelet reactivity.

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Detailed Description

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Cardiovascular events are a leading cause of mortality and morbidity in western countries. In the European Union, 47% of total mortality is caused by cardiovascular disease2. Aspirin is a cornerstone in the secondary prevention of cardiovascular disease because of its inhibitory effects on platelet aggregation. It reduces the risk of recurrent cardiovascular events with about a quarter3. Although not supported by evidence, aspirin is usually taken in the morning, but it may be more beneficial to take aspirin at bedtime instead of on awakening. It has been convincingly shown that platelet activity follows a circadian rhythm, with a peak of platelet reactivity in the morning4-8. This might in part explain the increase in cardiovascular events in the early morning, with the highest incidence between 6 and 12 AM1.

Since platelet reactivity follows a circadian rhythm, the timing of aspirin intake may influence its inhibitory effect on platelets. Due to its short half-life, aspirin only inhibits platelets which are present at the time of intake. New platelets are released at a rate of 10%/day, predominantly during the night9. Because they are more reactive and not inhibited by aspirin taken in the preceding morning, these young platelets contribute to the morning peak of platelet reactivity10, 11. It has been argued that intake of aspirin at bedtime could better prevent the early morning increase in platelet reactivity than intake on awakening, assuming that intake on awakening would be too late to prevent this morning peak in platelet reactivity12. Additionally, a recent study showed significant recovery of platelet aggregation after 24 hours in patients using low-dose aspirin on a daily basis13. This supports the hypothesis that aspirin intake at bedtime could be beneficial in reducing the morning peak of platelet reactivity, thereby possibly also reducing the incidence of arterial thrombotic events in the morning. However, this has never been studied before.

Conditions

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Aspirin Circadian Rhythm Platelet Activation Cardiovascular Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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aspirin on awakening

intake of 80 acetylsalicylic acid on awakening for 2 weeks

Group Type ACTIVE_COMPARATOR

change time of intake of aspirin

Intervention Type BEHAVIORAL

aspirin at bedtime

intake of 80mg acetylsalicylic acis at bedtime

Group Type EXPERIMENTAL

change time of intake of aspirin

Intervention Type BEHAVIORAL

Interventions

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change time of intake of aspirin

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Healthy subject
* Age \>18yrs
* Capacity to give informed consent (IC)

Exclusion Criteria

* Active chronic disease
* Use of any other medication
* History of: major bleeding events, known bleeding diathesis or disorder, cardiovascular disease, malignancy
* Known allergy to salicylates
* Platelet count \< 150 \* 109/L
* VerifyNow Aspirin Reaction Units \<550 Aspirin Reaction Units (ARU)
* Smoking
* Shift work in preceding 2 months
* Extreme chronotypes, defined as regular (\>2 days/week) bedtime \<22:00h or \>24:00h and/or awakening \<6:00h or \>9:00h
* Pregnancy

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes