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

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.

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.