Optimization of Blood Pressure Management After Acute Ischemic Stroke and Its Prognostic Significance

Seoul National University Bundang Hospital67 enrolled

Overview

BOSS-Trial I is a phase 2 clinical trial with the following objectives; 1. to prove the feasibility of a Bluetooth-equipped sphygmomanometer system in real-world clinical practice and wireless connection to the main server; 2. to prove the feasibility of the BP management strategy, including the pre-specified BP range, BP management algorithm, and behavioral; and 3. to gather information for the phase 3 trial including BP variability indices and their potentials as a treatment guidance.

* Elevated blood pressure is an established risk factor for recurrent stroke and vascular events in ischemic stroke survivors, but * Current guideline (JNC VIII) has omitted or only partially covered a number of practical and important issues as follow; * When and how we measure blood pressure? * Is it justifiable to apply the same blood pressure threshold for office BP and home BP? * Should stroke survivors be treated by the same BP goal for non-stroke subjects? * Is it justifiable to apply the universal BP threshold for different mechanisms of ischemic stroke? * Is it really about only blood pressure or might it really be "beyond blood pressure?" * Lifestyle modification should accompany all the pharmacological intervention but is usually in adequate to initiate behavioral changes. * Frequent BP measurement at home will provide more detailed and reliable information than occasional office BP's.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Ischemic Stroke

Interventions

Behavioral intensificationBEHAVIORAL

Suggested algorithm for behavioral intensification: * If frequency of BP measurement ≤5 in a week, send a texting message * If frequency of BP measurement ≤3 in a week, make a telephone contact by research nurse * Target range of home-systolic blood pressure: 110 - 135 * If rate of outlier exceeds 50% in a week (based on ≥5 measurements in a week), make a telephone contact by research nurse (applied at least 2 weeks after randomization). A call for breakthrough visit may be issued when clinically required (decided by the institutional investigator) * If frequency of BP measurement ≥ 10 in a week and frequency of outlier = 0 in a week, send a texting message to encourage and compliment on excellent BP management

Pharmacological intensification based on olmesartanDRUG

* Study drug will be provided from the roll-in period. * Step I: * Use olmesartan 20 mg only if mean systolic blood pressure ≤150 mm Hg during the immediate past 2 days * Use olmesartan 40 mg if mean systolic blood pressure \>150 during the immediate past 2 days * Step II: olmesartan 20 mg or 40 mg + amlodipine 5 mg * Step III: olmesartan 20 mg or 40 mg + amlodipine 10 mg * Step IV: olmesartan 20 mg or 40 mg + amlodipine 10 mg + hydrochlorothiazide 12.5 mg * If blood pressure profile showed high degree variability to evoke clinical concern, consider discontinuation of hydrochlorothiazide or reduction of olmesartan dose. * Use of beta-blockers is permitted if clinically indicated. * At each clinic visit regardless of regular or breakthrough visit, follow the pharmacological intensification rule.

Bluetooth-equipped sphygmomanometerDEVICE

* Participants will be given a wireless Bluetooth-equipped sphygmomanometer system, which is connected to the main server through the participants' own smartphone. (Identical for both intervention and control groups) * Every blood pressure and heart rate measured will be encrypted and stored in the main server. (Identical for both intervention and control groups)

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Ischemic stroke survivors within 7 days after onset * ≥19 year-old male or female * Medically and neurologically stabilized enough to take BP-lowering medication * Mean systolic blood pressure ≥135 mm Hg during two days between at least 24 hours after onset and randomization (whether BP-lowering medication was prescribed or not) * Capable of taking oral medication * Capable of operating a wireless Bluetooth-equipped sphygmomanometer system and being expected to follow required procedures of the clinical trial * Patients who provided written informed consent Exclusion Criteria: * Pregnant, puerperium ≤30 days or on breastfeeding * enrolled in other interventional clinical trial * Being transferred to rehabilitation center or institutionalized * Being expected to have cerebral artery interventions within 3 months after randomization * Known allergic reactions to olmesartan, amlodipine or hydrochlorothiazide * Known severe hepatic disease * Advanced kidney dysfunction requiring dialysis * Being unlikely, in the opinion of the investigator, to comply with the clinical trial protocol or being unsuitable for any other reason.