Effects of low-dose aspirin taken at bedtime on blood pressure of subjects with who use aspirin for prevention of recurrent cardiovascular events: the Aspirin In Reduction of Tension II (ASPIRETENSION II) Study - ASPIRETENSION II

Conditions: The medical condition to be investigated is hypertension
MedDRA version: 12.1Level: PTClassification code 10020772Term: Hypertension

Registration Number: EUCTR2010-024448-13-NL

Lead Sponsor: etherlands Heart Foundation

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 250

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

•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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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. <br>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

Secondary Outcome Measures