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

Seoul National University

Status and phase: Completed; Phase 2

Conditions: Hypertension; Ischemic Stroke

Treatments: Drug: Pharmacological intensification based on olmesartan; Behavioral: Behavioral intensification; Device: Bluetooth-equipped sphygmomanometer

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03024476

B-1604/343

Details and patient eligibility

About

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.

Full 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.

Enrollment: 67 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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67 participants in 2 patient groups

Intensive management arm

Experimental group

Description:

Description: * Interventions in the intensive management arm consist of 1) behavioral intensification and 2) pharmacological intensification based on olmesartan * Participants will be given a wireless Bluetooth-equipped sphygmomanometer system, which is connected to the main server through the participants' own smartphone. Every blood pressure and heart rate measured will be encrypted and stored in the main server (Identical for both intervention and control groups). * Regarding behavioral intensification, an automated texting and call for breakthrough visit will be sent from the main server to encourage regular measurements of BP and maintain a desirable goad of BP. * Regarding pharmacological intensification, a specific algorithm for BP-lowering medication prescription will be provided to the responsible physicians by the steering committee.

Treatment:

Behavioral: Behavioral intensification

Device: Bluetooth-equipped sphygmomanometer

Drug: Pharmacological intensification based on olmesartan

Control arm

Active Comparator group

Description:

Description: * Other than a bluetooth-equipped sphygmomanometer, standard managements abiding by the most current guideline will be provided from the responsible physicians. * Participants will be given a Bluetooth-equipped sphygmomanometer, which is connected to the main server through the participants' own smartphone. Every blood pressure and heart rate measured will be encrypted and stored in the main server (Identical for both intervention and control groups).

Treatment:

Device: Bluetooth-equipped sphygmomanometer