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Effectiveness of Night Administration of Low Dose Aspirin in Hypertensive Patients (TAHPS)

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ClinicalTrials.gov Identifier: NCT01741922
Recruitment Status : Completed
First Posted : December 5, 2012
Last Update Posted : February 3, 2017
Sponsor:
Collaborators:
Preventive Services and Health Promotion Research Network
Spanish Clinical Research Network - CAIBER
Public Health Service of Cataluña
Information provided by (Responsible Party):
Victoria Ruiz Arzalluz, 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.

Condition or disease Intervention/treatment Phase
Hypertension Drug: ASA evening Drug: Acetylsalicylic morning Drug: Placebos morning Drug: Placebo evening Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 230 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : December 2012
Actual Primary Completion Date : November 2015
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

Arm Intervention/treatment
Experimental: ASA evening&placebo morning
Patients will receive acetylsalicylic acid (100 mg)in the evening and placebo in the morning.
Drug: ASA evening
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
Other Names:
  • ASA
  • Low dose
  • aspirine

Drug: Placebos morning
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

Active Comparator: ASA morning&placebo evening
Patients will receive acetylsalicylic acid (100 mg) in the morning and placebo in the evening
Drug: Acetylsalicylic morning
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.
Other Names:
  • Asa
  • Low dose
  • aspirine

Drug: Placebo evening
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




Primary Outcome Measures :
  1. Mean SBP and DBP measured with Ambulatory Blood Pressure Monitoring (ABPM) over a 24 hour period [ Time Frame: 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 :
  1. Mean of day/night SBP and DBP ratios measured with Ambulatory Blood Pressure monitoring Monitoring [ Time Frame: 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.

  2. The mean of heart rate (HR) and the mean of pulse pressure (PP) [ Time Frame: 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.

  3. Percentage of adverse events related to ASA evening administration versus day administration [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01741922


Locations
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Spain
Primary Care Research Unit of Bizkaia
Bilbao, Bizkaia, Spain, 48014
Primary care of IDIAP Jordi Gol
Barcelona, Catalonia, Spain
Primary Care Research Unit of Bizkaia
Gipuzkoa Oeste, Gipuzkoa, Spain
Sponsors and Collaborators
Basque Health Service
Preventive Services and Health Promotion Research Network
Spanish Clinical Research Network - CAIBER
Public Health Service of Cataluña
Investigators
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Principal Investigator: Victoria Ruíz, Dr. Basque Health Service

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Victoria Ruiz Arzalluz, Primary Care Practitioner in Basque Health Service, Basque Health Service
ClinicalTrials.gov Identifier: NCT01741922     History of Changes
Other Study ID Numbers: TAHPS-2011-004760-29
First Posted: December 5, 2012    Key Record Dates
Last Update Posted: February 3, 2017
Last Verified: February 2017
Keywords provided by Victoria Ruiz Arzalluz, Basque Health Service:
Low dose
aspirin
ASA
Hypertension
blood pressure
Additional relevant MeSH terms:
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Aspirin
Hypertension
Vascular Diseases
Cardiovascular Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics