The medical condition to be investigated is hypertension MedDRA version: 12.1 Level: PT Classification code 10020772 Term: Hypertension
Conditions
Interventions
Product Name: carbasalate calcium
Product Code: RVG 16831
Pharmaceutical Form: Powder for oral suspension
Sponsors
Netherlands Heart Foundation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Use of low-dose aspirin for secondary prevention of cardiovascular events • Stable blood pressure (with or without therapy) of 149/94 or lower • Age 18-80 year • 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Blood pressure of 150/95 or higher • Change in blood pressure lowering medication within the last three months • Regular use of non-steroidal anti-inflammatory drugs (NSAID's) • Shift workers • Evidence of secondary arterial hypertension • Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To study the effect of 100 mg aspirin intake at bedtime compared with 100 mg aspirin intake at morning on blood pressure (24h ambulatory blood pressure measurements (ABPM)) in patients who use aspirin for secondary prevention of recurrent atherothrombotic events.;Secondary Objective: We will study the effect of aspirin intake at bedtime compared with at morning on platelet function. Additionally, we will asses the effect of aspirin intake at bedtime on compliance and potential side effects of aspirin, as well as potential effect modification of the effect on blood pressure by genes involved in blood pressure regulation;Primary end point(s): • 24h Ambulant blood pressure measurement | — |
Countries
Netherlands
Outcome results
None listed