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

NCT ID: NCT03024476

Last Updated: 2018-04-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-01
• Study Completion Date: 2017-12-07

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.

Conditions

Ischemic Stroke; Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intensive management arm

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.

Group Type: EXPERIMENTAL

Behavioral intensification

Intervention Type: BEHAVIORAL

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

Pharmacological intensification based on olmesartan

Intervention Type: DRUG

• 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.

Bluetooth-equipped sphygmomanometer

Intervention Type: DEVICE

• 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)

Control arm

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).

Group Type: ACTIVE_COMPARATOR

Bluetooth-equipped sphygmomanometer

Intervention Type: DEVICE

• 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)

Interventions

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

Intervention Type: BEHAVIORAL

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.

Intervention Type: DRUG

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)

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Daiichi Sankyo Korea Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Seoul National University Bundang Hospital

OTHER

Sponsor Role: lead

Responsible Party

Hee-Joon Bae

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hee-Joon Bae, MD.PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital

Locations

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Nowon Eulji Medical Center, Eulji University

Seoul, , South Korea

Seoul Medical Center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

B-1604/343

Identifier Type: -

Identifier Source: org_study_id