NCT03024476

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

Optimization of Blood Pressure Management After Acute Ischemic Stroke and Its Prognostic Significance: Prospective, Randomized, Open, Blinded Outcome Evaluation, and Feasibility Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: Seoul National University Bundang Hospital · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

* 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.

Conditions

• Ischemic Stroke
• Hypertension

Interventions

Type	Name	Description
BEHAVIORAL	Behavioral intensification	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
DRUG	Pharmacological intensification based on olmesartan	* 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.
DEVICE	Bluetooth-equipped sphygmomanometer	* 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)

Timeline

• Start date: 2016-09-01
• Primary completion: 2017-12-07
• Completion: 2017-12-07
• First posted: 2017-01-18
• Last updated: 2018-04-06

Locations

3 sites across 1 country: South Korea