Effectiveness of Night Administration of Low Dose Aspirin in Hypertensive Patients

Phase 3

Completed

• Conditions: Hypertension
• Interventions: Drug: ASA evening; Drug: Acetylsalicylic morning; Drug: Placebos morning; Drug: Placebo evening

• Registration Number: NCT01741922
• Lead Sponsor: Basque Health Service

Brief Summary

The goal is to investigate in patients with high blood pressure, BP, namely, those with systolic blood pressure and diastolic blood pressure, SBP/DBP higher than or equal to 140/90 mmHg, and high cardiovascular risk, under treatment with low-dose acetylsalicylic acid, ASA, whether changing the time they take the drug (same dose) to bedtime (from taking it at some point during the active part of the day) produces a drop in their blood pressure (mean systolic and diastolic over 24 hours) of at least 2.5 mm Hg; and also whether among non-dippers, under secondary treatment with low-dose ASA, there is be a greater decrease in their night BP when the drug is taken in the evening.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-11-07
• Study Start: 2012-12
• Study First Submitted QC: 2012-12-03
• Study First Posted: 2012-12-05
• Primary Completion: 2015-11
• Study Completion: 2016-01
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-02
• Last Update Posted: 2017-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 230

Inclusion Criteria

• Hypertensive patients (≥140/90)
• Patients from 18 to 80 years old
• Patients are currently taking low doses of ASA during the day, for secondary prevention of cardiovascular events
• Patients have been stable for at least one month with their current antihypertensive and antiplatelet therapy.

Exclusion Criteria

• Severe and/or terminal illness
• Moderate/severe congestive heart failure (CHF), New York Heart Association, NYHA stage ≥ III
• Moderate/severe chronic renal failure glomerular filtration rate <45ml/min.
• Physical or mental illness that prevents the patient´s collaboration
• Being a heavy drinker, consuming more than 280 g of alcohol per week in the case of men or 170 g for women31
• Concomitant treatment with other antiplatelets or anticoagulants
• Taking nonsteroidal antiinflammatory drugs, NSAIDs, on a regular basis
• Treatment with ASA at doses outside those established in the inclusion criteria (above)
• ASA already being taken in the evening
• Being a shift worker or having a very intensive work schedule
• Hospital admission during the clinical trial
• Changes being made in the antihypertensive and antiplatelet therapy taken by the patient during the seven months of the trial
• Patients with unstable treatment or clinical condition requiring frequent adjustments thereof.
• Compliance with less than 90% of the doses, both those for daytime and those for evening administration

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
ASA evening&placebo morning	ASA evening	Patients will receive acetylsalicylic acid (100 mg)in the evening and placebo in the morning.
ASA evening&placebo morning	Placebos morning	Patients will receive acetylsalicylic acid (100 mg)in the evening and placebo in the morning.
ASA morning&placebo evening	Acetylsalicylic morning	Patients will receive acetylsalicylic acid (100 mg) in the morning and placebo in the evening
ASA morning&placebo evening	Placebo evening	Patients will receive acetylsalicylic acid (100 mg) in the morning and placebo in the evening

Primary Outcome Measures

Name	Time	Method
Mean SBP and DBP measured with Ambulatory Blood Pressure Monitoring (ABPM) over a 24 hour period	Change from baseline in sistolyc blood pressure at five months	To evaluate the effect of evening administration of low doses of aspirin (100 mg) on the BP of hypertensive patients with high cardiovascular risk, comparing with the effect of day administration, we are going to measure the change in the mean SBP and DBP measured with Ambulatory Blood Pressure Monitoring (ABPM) over a 24 hour period from baseline at the end of the study, five months later.

Secondary Outcome Measures

Name	Time	Method
Mean of day/night SBP and DBP ratios measured with Ambulatory Blood Pressure monitoring Monitoring	Change from baseline in sistolyc blood pressure at five months	To optimize the control of BP in hypertensive patients treated with low doses of aspirin for secondary prevention. We are going to describe the changes in day-night pattern of BP as a function of the time of administration of low doses of aspirin in non-dipper patients, objectified by the mean of day:night SBP and DBP ratios.
Percentage of adverse events related to ASA evening administration versus day administration	Change from baseline in sistolyc blood pressure at five months	we are going to measured the percentage of adverse events at the end of the study to assess any changes in the side effects of aspirin when it is taken in the evening compared to day-time administration.
The mean of heart rate (HR) and the mean of pulse pressure (PP)	Change from baseline in sistolyc blood pressure at five months	To optimize the control of BP in hypertensive patients treated with low doses of aspirin for secondary prevention. We are going to identify any changes in the mean of heart rate (HR) and the mean of pulse pressure (PP) with evening administration of ASA.

Trial Locations

Locations (2)

Primary care of IDIAP Jordi Gol; 🇪🇸 Barcelona, Catalonia, Spain

Primary Care Research Unit of Bizkaia; 🇪🇸 Gipuzkoa Oeste, Gipuzkoa, Spain