NCT01741922

Effectiveness of Night Administration of Low Dose Aspirin in Hypertensive Patients

Effectiveness of the Timing of the Administration of Aspirin in Hypertensive Patients Treated With Low Doses of Acetyl Salicylic Acid for Secondary Prevention - TAHPS

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 230 (actual)
• Sponsor: Basque Health Service · Other Government
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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
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.
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
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

Timeline

• Start date: 2012-12-01
• Primary completion: 2015-11-01
• Completion: 2016-01-01
• First posted: 2012-12-05
• Last updated: 2017-02-03

Locations

3 sites across 1 country: Spain