Clinical trial NCT01741922: Effectiveness of Night Administration of Low Dose Aspirin in Hypertensive Patients
Official title: Effectiveness of the Timing of the Administration of Aspirin in Hypertensive Patients Treated With Low Doses of Acetyl Salicylic Acid for Secondary Prevention - TAHPS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Keywords: Low dose
aspirin
ASA
Hypertension
blood pressure
Lead sponsor: Basque Health Service
Sponsor class: OTHER_GOV
Collaborators: name: Preventive Services and Health Promotion Research Network
name: Spanish Clinical Research Network - SCReN
name: Public Health Service of Cataluña
First posted: 2012-12-05
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Mean SBP and DBP measured with Ambulatory Blood Pressure Monitoring (ABPM) over a 24 hour period
timeFrame: Change from baseline in sistolyc blood pressure at five months
Secondary outcomes:
measure: Mean of day/night SBP and DBP ratios measured with Ambulatory Blood Pressure monitoring Monitoring
timeFrame: Change from baseline in sistolyc blood pressure at five months
measure: The mean of heart rate (HR) and the mean of pulse pressure (PP)
timeFrame: Change from baseline in sistolyc blood pressure at five months
measure: Percentage of adverse events related to ASA evening administration versus day administration
timeFrame: Change from baseline in sistolyc blood pressure at five months
Other outcomes:
Locations:
city: Bilbao
country: Spain
facility: Primary Care Research Unit of Bizkaia
state: Bizkaia
city: Barcelona
country: Spain
facility: Primary care of IDIAP Jordi Gol
state: Catalonia
city: Gipuzkoa Oeste
country: Spain
facility: Primary Care Research Unit of Bizkaia
state: Gipuzkoa
Study officials:
affiliation: Basque Health Service
name: Victoria Ruíz, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ruiz-Arzalluz MV, Fernandez MC, Burgos-Alonso N, Vinyoles E, San Vicente Blanco R, Grandes G; TAHPS group. Protocol for assessing the hypotensive effect of evening administration of acetylsalicylic acid: study protocol for a randomized, cross-over controlled trial. Trials. 2013 Jul 27;14:236. doi: 10.1186/1745-6215-14-236.
citation: Ruiz Arzalluz MV, Burgos-Alonso N, Garcia-Alvarez A, Gomez Fernandez MC, Vinyoles E, Grandes G; TAHPS Group. Evaluation of the antihypertensive effect of nocturnal administration of acetylsalicylic acid: a cross-over randomized clinical trial. J Hypertens. 2019 Feb;37(2):406-414. doi: 10.1097/HJH.0000000000001887.