HypertensionPhase 3TAHPSNCT01741922
Effectiveness of Night Administration of Low Dose Aspirin in Hypertensive Patients
A Phase 3 study testing ASA evening and Acetylsalicylic morning in people with Hypertension, run by Basque Health Service at 3 sites in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypertension
- What is being tested?
- ASA evening and Acetylsalicylic morning
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 230 participants
- Where
- 3 sitesSpain
- Study dates
- Dec 2012to Jan 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
Spain3 sites
Primary care of IDIAP Jordi Gol
Barcelona, Catalonia
Primary Care Research Unit of Bizkaia
Bilbao, Bizkaia, 48014
Primary Care Research Unit of Bizkaia
Gipuzkoa Oeste, Gipuzkoa
About this study
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
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
- Being tested
- ASA evening, Acetylsalicylic morning, Placebos morning, Placebo evening
- Keywords
- Low dose, aspirin, ASA, Hypertension, blood pressure
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASA eveningDrug
Also called ASA, Low dose, aspirine
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
Acetylsalicylic morningDrug
Also called Asa, Low dose, aspirine
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.
Placebos morningDrug
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
Placebo eveningDrug
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
| Study group | Role | What they receive |
|---|---|---|
| ASA evening&placebo morning | Experimental | Patients will receive acetylsalicylic acid (100 mg)in the evening and placebo in the morning. Receives: 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 Receives: Drug: Acetylsalicylic morning; Drug: Placebo evening |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: Change from baseline in sistolyc blood pressure at five months
The mean of heart rate (HR) and the mean of pulse pressure (PP)
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.
Measured: Change from baseline in sistolyc blood pressure at five months
Percentage of adverse events related to ASA evening administration versus day administration
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.
Measured: Change from baseline in sistolyc blood pressure at five months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionNov 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Basque Health Service
- Sponsor type
- Other government
- Collaborators
- Preventive Services and Health Promotion Research Network, Spanish Clinical Research Network - SCReN, Public Health Service of Cataluña
- Responsible party
- Principal investigator, Victoria Ruiz Arzalluz, Basque Health Service
- Investigators
- Victoria Ruíz, Dr., Principal investigator, Basque Health Service
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01741922
- Sponsor's protocol ID
- TAHPS-2011-004760-29
- Acronym
- TAHPS
- Status last verified
- Feb 2017
- First submitted
- 7 Nov 2012
- Last updated
- 3 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23890047Ruiz 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.
PubMed 30095728
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01741922
- Acronym / sponsor ID
- TAHPS / TAHPS-2011-004760-29
- Conditions
- Hypertension
- Keywords
- Low dose, aspirin, ASA, Hypertension, blood pressure
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Basque Health ServiceOther government
- Collaborators
- Preventive Services and Health Promotion Research Network, Spanish Clinical Research Network - SCReN, Public Health Service of Cataluña
- Study start
- Dec 2012 (actual)
- Primary completion
- Nov 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 5 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ASA evening&placebo morning | Experimental | Drug: ASA evening, Drug: Placebos morningPatients will receive acetylsalicylic acid (100 mg)in the evening and placebo in the morning. |
| ASA morning&placebo evening | Active comparator | Drug: Acetylsalicylic morning, Drug: Placebo eveningPatients will receive acetylsalicylic acid (100 mg) in the morning and placebo in the evening |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ASA eveningAlso: ASA, Low dose, aspirinePatients 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 | Drug | ASA evening&placebo morning |
| Acetylsalicylic morningAlso: Asa, Low dose, aspirinePatients 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. | Drug | ASA morning&placebo evening |
| Placebos morningPatients 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 | Drug | ASA evening&placebo morning |
| Placebo eveningPatients 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 | Drug | ASA morning&placebo evening |
Primary outcome
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.
3 secondary outcomes
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
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
Percentage of adverse events related to ASA evening administration versus day administration
Time frame: Change from baseline in sistolyc blood pressure at five months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2017.
- Background: PubMed 23890047Ruiz-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.
- Derived from this study: PubMed 30095728Ruiz 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Victoria Ruíz, Dr. principal investigator
Basque Health Service
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ASA evening and Acetylsalicylic morning in people with Hypertension, run by Basque Health Service at 3 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01741922, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2017.