hypertension MedDRA version: 14.1 Level: LLT Classification code 10020775 Term: Hypertension arterial System Organ Class: 10047065 - Vascular disorders
Conditions
Interventions
Trade Name: Acetylsalicylic acid 100mg
Product Name: acetylsalicylic acid
Product Code: C0036079
Pharmaceutical Form: Tablet
INN or Proposed INN: ACETYLSALICYLIC ACID
CAS Number: 50-78-2
Other descrip
Sponsors
Maria Victoria Ruiz Arzalluz
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All participants are to be hypertensive patients (?140/90) between 18 and 80 years old who are currently taking low doses of ASA, for secondary prevention of cardiovascular events Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 230 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 28
Exclusion criteria
Exclusion criteria: Severe and/or terminal illness Congestive heart failure (CHF) Moderate/severe chronic renal failure 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 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
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Hematologic analysis Adverse effects;Timepoint(s) of evaluation of this end point: Hematologic analysis: baseline and at the end of the study Adverse effects: monthly | — |
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: ? To optimize the control of BP in hypertensive patients treated with low doses of aspirin for secondary prevention. ? To compare the hypotensive effect of evening administration of low dose of aspirin in different subgroups, as a function of age, sex, and values of serum creatinine. ? To estimate the percentage of non-dippers and dippers among the population of hypertensive patients at high cardiovascular risk. ? To identify any changes in heart rate (HR) and pulse pressure (PP) with evening administration of ASA. ? 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 day:night SBP and DBP ratios. ? To assess any changes in the side effects of aspirin when taken in the evening compared to day-time administration.;Main Objective: 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, estimated by calculating the mean SBP and DBP measured over a 24 hour period;Primary end point(s): Blood Preasure;Timepoint(s) of evaluation of this end point: baseline after first period after washout after the second period(final of the study) | — |
Countries
Spain
Contacts
Public ContactNatalia Burgos-Alonso
Unidad de Atención Primaria de Bizkaia
Outcome results
None listed