cardiovasculaire aandoeningen cardiovascular diseases
Conditions
Interventions
After patients written informed consent, subjects will be randomised between
aspirin at awakening or at bedtime in treatment periods of 4 years.
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: patients who already use low-dose aspirin for secondary prevention of cardiovascular events and use a multidose drug dispensing
Exclusion criteria
Exclusion criteria: Insufficient knowledge of the Dutch language Patients currently participating in another (clinical) trial or study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effect of aspirin intake at bedtime compared with intake at morning on cardiovascular disease | — |
Secondary
| Measure | Time frame |
|---|---|
| * Time of the day of primary outcome: it is expected that bedtime aspirin reduces the primary outcome more during morning hours (6-12h) compared with the rest of the day. * Safety: severe or moderate bleeding events according to established definitions. * Side-effects * Cost-effectiveness: patients* quality of life (EQ-5D-5L) will be registered at randomization and after that with a frequency of twice per year during follow-up to calculate QALYs. Health care utilization data are extracted from electronic patient records and data from the primary care. Health care use will be translated into cost using Dutch reference prices. * Subgroup analyses will be performed for gender and age (18-50, 50-65, 65-85 and 85+). | — |
Countries
Netherlands
Outcome results
None listed