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

NCT03024476 | Completed Phase 2 DMC

• 1 other identifier: B-1604/343
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 3

Brief Summary

BOSS-Trial I is a phase 2 clinical trial with the following objectives;

1. 1.to prove the feasibility of a Bluetooth-equipped sphygmomanometer system in real-world clinical practice and wireless connection to the main server;
2. 2.to prove the feasibility of the BP management strategy, including the pre-specified BP range, BP management algorithm, and behavioral; and
3. 3.to gather information for the phase 3 trial including BP variability indices and their potentials as a treatment guidance.

Conditions

Ischemic Stroke; Hypertension

Keywords

behavioral intervention; prespecified medication algorithm; bluetooth-equipped sphygmomanometer

Outcome Measures

Primary Outcomes (5)

• Recruitment time to prespecified number of subjects

  Difference in days between recruitment of the first subject and last subject

  At 3 months after randomization

• Retention of included participants

  Ratio of completed subject over randomized subjects in each group

  At 3 months after randomization

• Frequencies of calls for breakthrough visit

  Mean and standard deviation of breakthrough visits per each patient in the intensive management group

  At 3 months after randomization

• Rate of patients who responded to the calls for breakthrough visit

  ratio of subjects response over the breakthrough visit calls

  At 3 months after randomization

• Control of blood pressure

  ratio of subjects with well-controlled BP in each group

  At 3 months after randomization

Secondary Outcomes (4)

• Frequency of out-of-range measurement

  At 3 months after randomization

• Weighted hit score of BP

  At 3 months after randomization

• Vascular events

  At 3 months after randomization

• Hypotensive events

  Until 3 months after randomization

Study Arms (2)

Intensive management arm

EXPERIMENTAL

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.

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

Control arm

ACTIVE COMPARATOR

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).

Device: Bluetooth-equipped sphygmomanometer

Interventions

Behavioral intensification 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

Intensive management arm

Pharmacological intensification based on olmesartan 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.

Intensive management arm

Bluetooth-equipped sphygmomanometer 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; Intensive management arm

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead
• Daiichi Sankyo Korea Co., Ltd.: collaborator

Study Sites (3)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13520, South Korea

Location

Nowon Eulji Medical Center, Eulji University

Seoul, 01830, South Korea

Location

Seoul Medical Center

Seoul, 02053, South Korea

Location

MeSH Terms

Conditions

Ischemic Stroke; Hypertension

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Hee-Joon Bae, MD.PhD

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 3, 2017
• First Posted: January 18, 2017
• Study Start: September 1, 2016
• Primary Completion: December 7, 2017
• Study Completion: December 7, 2017
• Last Updated: April 6, 2018

Record last verified: 2018-04

Locations

KR (3)