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

• Status: Completed
• Trial end date: 2017-12-07
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Bundang Hospital
• Collaborator: Daiichi Sankyo Korea Co., Ltd.
• Treatments: Olmesartan; Olmesartan Medoxomil

Criteria

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.