Effectiveness of Night Administration of Low Dose Aspirin in Hypertensive Patients
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 3

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.
    


Intervention name(s): ASA evening; Acetylsalicylic morning; Placebos morning; Placebo evening
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 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; 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.; 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; 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 intervention name(s): ASA; Low dose; aspirine; Asa; Low dose; aspirine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Low dose; aspirin; ASA; Hypertension; blood pressure