NCT01379079: ASPIRETENSION

Aspirin AM or PM in Reduction of Tension: a Randomized Cross-over Trial

Completed Phase 4 Last updated 12 May 2014

What this trial tests

Phase 4 trial testing Acetylsalicylic acid in Hypertension in 290 participants. Completed in 1 October 2013.

Timeline

1 April 2011

Primary endpoint
1 October 2013

1 October 2013

Quick facts

Lead sponsor	Leiden University Medical Center
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	290
Start date	1 April 2011
Primary completion	1 October 2013
Estimated completion	1 October 2013
Sites	1 location across Netherlands

Drugs / interventions tested

• Acetylsalicylic acid (acetylsalicylic acid) — full drug profile →
• Acetylsalicylic acid lysinate — full drug profile →

Conditions studied

• Hypertension — all drugs for Hypertension →
• Cardiovascular Diseases — all drugs for Cardiovascular Diseases →

Sponsor

Leiden University Medical Center

Who can join

Adults 18 to 75, any sex, with Hypertension or Cardiovascular Diseases. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• change in 24h Ambulant blood pressure measurement
  Time frame: after 3 and 6 months
  Primary endpoint: 24-hour Ambulatory blood pressure (ABPM). The primary endpoint will be analysed in primary- and secondary analysis. Primary analysis population: all randomized subjects with complete follow-up ABPM. Includes subjects with invalid ABPM, change in antihypertensive medication during follow-up, and subjects with low compliance. Analyses: 1) paired t-tests: mean 24-hour blood pressure

Sponsor's own description

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. Recent studies in healthy subjects with mild hypertension showed that aspirin at bedtime decreases blood pressure (-7/5mmHg), whereas intake of aspirin on awakening does not. Additionally, the investigators found that aspirin at bedtime decreases plasma renin activity, catecholamines and cortisol over 24hrs. Time-dependent effects of aspirin have never been studied in patients with CVD, who may use concomitant antihypertensive drugs. Moreover, platelet reactivity has a circadian rhythm, and intake of aspirin at bedtime may attenuate the morning peak in platelet reactivity. The investigators hypothesize that aspirin intake at bedtime compared with on awakening decreases both blood pressure and platelet reactivity over 24h.

A randomized open-label blinded endpoint crossover trial in which 250 patients, recruited from primary care, will be included who use aspirin for secondary prevention of CVD and have a stable blood pressure of 149/94mmHg or lower. Study subjects will randomly use both aspirin on awakening and at bedtime during two intervention periods of three months. Blood pressure will be recorded for 24hrs at the end of each treatment period in the patients' normal daily situation. To assess effects on platelet inhibition, thromboxane-B2 levels will be measured in a 24h urine sample at the end of both treatment periods. The investigators will asses differential effects according to time of intake on gastrointestinal complaints and potential minor bleeding events, as well as compliance.

The aim of this study is to evaluate the effect of aspirin taken at bedtime compared with on awakening on blood pressure of subjects with stable CVD. In addition, it will generate insights into the effect of aspirin on platelet reactivity over 24hrs, potential side effects and compliance.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.