Effectiveness of Night Administration of Low Dose Aspirin in Hypertensive Patients

• Status: Completed
• Trial end date: 2016-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Basque Health Service
• Collaborators: Preventive Services and Health Promotion Research Network; Public Health Service of Cataluña; Spanish Clinical Research Network - CAIBER; Spanish Clinical Research Network - SCReN
• Treatments: Aspirin

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