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

Basque Health Service

Status and phase: Completed; Phase 3

Conditions: Hypertension

Treatments: Drug: Acetylsalicylic morning; Drug: ASA evening; Drug: Placebos morning; Drug: Placebo evening

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT01741922

TAHPS-2011-004760-29

Details and patient eligibility

About

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.

Enrollment: 230 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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230 participants in 2 patient groups

ASA evening&placebo morning

Experimental group

Description:

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

Treatment:

Drug: ASA evening

Drug: Placebos morning

ASA morning&placebo evening

Active Comparator group

Description:

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

Treatment:

Drug: Acetylsalicylic morning

Drug: Placebo evening