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

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.

Conditions

• Ischemic Stroke
• Hypertension

Interventions

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)

Sponsors & Collaborators

• Daiichi Sankyo Korea Co., Ltd.

  collaborator INDUSTRY

• Seoul National University Bundang Hospital

  lead OTHER

Principal Investigators

• Hee-Joon Bae, MD.PhD · Seoul National University Bundang Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

19 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-09-01

Primary Completion

2017-12-07

Completion

2017-12-07

Countries

• South Korea

Study Locations