Effectiveness of Night Administration of Low Dose Aspirin in Hypertensive Patients

NCT01741922 | Completed Phase 3

• 1 other identifier: TAHPS-2011-004760-29
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 3

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.

Conditions

Hypertension

Keywords

Low dose; aspirin; ASA; Hypertension; blood pressure

Outcome Measures

Primary Outcomes (1)

• Mean SBP and DBP measured with Ambulatory Blood Pressure Monitoring (ABPM) over a 24 hour period

  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.

  Change from baseline in sistolyc blood pressure at five months

Secondary Outcomes (3)

• 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

• The mean of heart rate (HR) and the mean of pulse pressure (PP)

  Change from baseline in sistolyc blood pressure at five months

• Percentage of adverse events related to ASA evening administration versus day administration

  Change from baseline in sistolyc blood pressure at five months

Study Arms (2)

ASA evening&placebo morning

EXPERIMENTAL

Patients will receive acetylsalicylic acid (100 mg)in the evening and placebo in the morning.

Drug: ASA evening; Drug: Placebos morning

ASA morning&placebo evening

ACTIVE COMPARATOR

Patients will receive acetylsalicylic acid (100 mg) in the morning and placebo in the evening

Drug: Acetylsalicylic morning; Drug: Placebo evening

Interventions

ASA evening DRUG

Patients will be assigned to one of two parallel groups: Active comparator group during the first two months, namely, administration of acetylsalicylic acid 100 mg, in the morning and placebo in the evening and Experimental: Acetylsalicylic acid in the evening \& placebo in the morning group, of administration of acetylsalicylic acid 100 mg in the evening, between (20.00 and 22.00 hours) and placebo in the morning. After that, patients will then undergo a washout period of 15 days to one month, during which all patients participating in the study will take their ASA doses during the daytime. After the washout period, participants will exchange groups

Also known as: ASA, Low dose, aspirine

ASA evening&placebo morning

Acetylsalicylic morning DRUG

Patients will be assigned in a blind and randomized way to one of two parallel groups: group I with the control treatment during the first two months, namely, administration of aspirin 100 mg, in the morning and placebo in the evening and group II initially receiving the intervention, of administration of aspirin 100 mg in the evening, between (20.00 and 22.00 hours) and placebo in the morning. After that, patients will then undergo a washout period of 15 days to one month, during which all patients participating in the study will take their ASA doses during the daytime. After the washout period, participants will exchange groups, i.e., patients randomly allocated to group I, so having taken aspirin in the morning and placebo in the evening, will now receive the intervention treatment, namely, administration of ASA in the evening and placebo in the morning for another two months and vice verse.

Also known as: Asa, Low dose, aspirine

ASA morning&placebo evening

Placebos morning DRUG

Patients will be assigned to one of two parallel groups: Active comparator group during the first two months, namely, administration of acetylsalicylic acid 100 mg, in the morning and placebo in the evening and Experimental: Acetylsalicylic acid in the evening \& placebo in the morning group, of administration of acetylsalicylic acid 100 mg in the evening, between (20.00 and 22.00 hours) and placebo in the morning. After that, patients will then undergo a washout period of 15 days to one month, during which all patients participating in the study will take their ASA doses during the daytime. After the washout period, participants will exchange groups

ASA evening&placebo morning

Placebo evening DRUG

Patients will be assigned to one of two parallel groups: Active comparator group during the first two months, namely, administration of acetylsalicylic acid 100 mg, in the morning and placebo in the evening and Experimental: Acetylsalicylic acid in the evening \& placebo in the morning group, of administration of acetylsalicylic acid 100 mg in the evening, between (20.00 and 22.00 hours) and placebo in the morning. After that, patients will then undergo a washout period of 15 days to one month, during which all patients participating in the study will take their ASA doses during the daytime. After the washout period, participants will exchange groups

ASA morning&placebo evening

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Basque Health Service: lead
• Preventive Services and Health Promotion Research Network: collaborator
• Spanish Clinical Research Network - SCReN: collaborator
• Public Health Service of Cataluña: collaborator

Study Sites (3)

Primary Care Research Unit of Bizkaia

Bilbao, Bizkaia, 48014, Spain

Location

Primary care of IDIAP Jordi Gol

Barcelona, Catalonia, Spain

Location

Primary Care Research Unit of Bizkaia

Gipuzkoa Oeste, Gipuzkoa, Spain

Location

Related Publications (2)

• 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.

  PMID: 23890047 BACKGROUND

• 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.

  PMID: 30095728 DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

Contraceptives, Oral; Aspirin

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Contraceptive Agents, Female; Contraceptive Agents; Reproductive Control Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Victoria Ruíz, Dr.

  Basque Health Service

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Care Practitioner in Basque Health Service

Study Record Dates

• First Submitted: November 7, 2012
• First Posted: December 5, 2012
• Study Start: December 1, 2012
• Primary Completion: November 1, 2015
• Study Completion: January 1, 2016
• Last Updated: February 3, 2017

Record last verified: 2017-02

Locations

ES (3)