Clinical trial NCT03024476: Optimization of Blood Pressure Management After Acute Ischemic Stroke and Its Prognostic Significance
Official title: Optimization of Blood Pressure Management After Acute Ischemic Stroke and Its Prognostic Significance: Prospective, Randomized, Open, Blinded Outcome Evaluation, and Feasibility Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ischemic Stroke
Hypertension
Keywords: behavioral intervention
prespecified medication algorithm
bluetooth-equipped sphygmomanometer
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
Collaborators: name: Daiichi Sankyo Korea Co., Ltd.
First posted: 2017-01-18
Enrollment: 67
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility 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.

Primary outcomes:
measure: Recruitment time to prespecified number of subjects
timeFrame: At 3 months after randomization
measure: Retention of included participants
timeFrame: At 3 months after randomization
measure: Frequencies of calls for breakthrough visit
timeFrame: At 3 months after randomization
measure: Rate of patients who responded to the calls for breakthrough visit
timeFrame: At 3 months after randomization
measure: Control of blood pressure
timeFrame: At 3 months after randomization
Secondary outcomes:
measure: Frequency of out-of-range measurement
timeFrame: At 3 months after randomization
measure: Weighted hit score of BP
timeFrame: At 3 months after randomization
measure: Vascular events
timeFrame: At 3 months after randomization
measure: Hypotensive events
timeFrame: Until 3 months after randomization
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi
city: Seoul
country: Korea, Republic of
facility: Nowon Eulji Medical Center, Eulji University
city: Seoul
country: Korea, Republic of
facility: Seoul Medical Center
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Hee-Joon Bae, MD.PhD
role: PRINCIPAL_INVESTIGATOR
References: