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

Primary Purpose

Ischemic Stroke, Hypertension

Status

Completed

Phase

Phase 2

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Behavioral intensification

Pharmacological intensification based on olmesartan

Bluetooth-equipped sphygmomanometer

About this trial

This is an interventional treatment trial for Ischemic Stroke focused on measuring behavioral intervention, prespecified medication algorithm, bluetooth-equipped sphygmomanometer

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Seoul National University Bundang Hospital
Nowon Eulji Medical Center, Eulji University
Seoul Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intensive management arm

Control arm

Arm 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.

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).

Outcomes

Primary Outcome Measures

Recruitment time to prespecified number of subjects

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

Retention of included participants

Ratio of completed subject over randomized subjects in each group

Frequencies of calls for breakthrough visit

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

Rate of patients who responded to the calls for breakthrough visit

ratio of subjects response over the breakthrough visit calls

Control of blood pressure

ratio of subjects with well-controlled BP in each group

Secondary Outcome Measures

Frequency of out-of-range measurement

Frequency of BP measurements out of the desirable BP range in a week

Weighted hit score of BP

When two consecutive hits crossed over or below the margin of desirable BP, give 2x weight. Final score will be generated by dividing by total number of measurements

Vascular events

Recurrent vascular events including recurrent stroke, myocardial infarction or vascular death

Hypotensive events

Complaint of dizzy spells, falls or low-BP related events by patients

Full Information

NCT ID

NCT03024476

First Posted

January 3, 2017

Last Updated

April 4, 2018

Sponsor

Seoul National University Bundang Hospital

Collaborators

Daiichi Sankyo Korea Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT03024476

Brief Title

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

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Completed

Study Start Date

September 1, 2016 (Actual)

Primary Completion Date

December 7, 2017 (Actual)

Study Completion Date

December 7, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Seoul National University Bundang Hospital

Collaborators

Daiichi Sankyo Korea Co., Ltd.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

BOSS-Trial I is a phase 2 clinical trial with the following objectives; to prove the feasibility of a Bluetooth-equipped sphygmomanometer system in real-world clinical practice and wireless connection to the main server; to prove the feasibility of the BP management strategy, including the pre-specified BP range, BP management algorithm, and behavioral; and 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ischemic Stroke, Hypertension

Keywords

behavioral intervention, prespecified medication algorithm, bluetooth-equipped sphygmomanometer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

67 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intensive management arm

Arm Type

Experimental

Arm Description

Arm Title

Control arm

Arm Type

Active Comparator

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Behavioral intensification

Intervention Description

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

Drug

Intervention Name(s)

Pharmacological intensification based on olmesartan

Intervention Description

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

Device

Intervention Name(s)

Bluetooth-equipped sphygmomanometer

Intervention Description

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)

Primary Outcome Measure Information:

Title

Recruitment time to prespecified number of subjects

Description

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

Time Frame

At 3 months after randomization

Title

Retention of included participants

Description

Ratio of completed subject over randomized subjects in each group

Time Frame

At 3 months after randomization

Title

Frequencies of calls for breakthrough visit

Description

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

Time Frame

At 3 months after randomization

Title

Rate of patients who responded to the calls for breakthrough visit

Description

ratio of subjects response over the breakthrough visit calls

Time Frame

At 3 months after randomization

Title

Control of blood pressure

Description

ratio of subjects with well-controlled BP in each group

Time Frame

At 3 months after randomization

Secondary Outcome Measure Information:

Title

Frequency of out-of-range measurement

Description

Frequency of BP measurements out of the desirable BP range in a week

Time Frame

At 3 months after randomization

Title

Weighted hit score of BP

Description

When two consecutive hits crossed over or below the margin of desirable BP, give 2x weight. Final score will be generated by dividing by total number of measurements

Time Frame

At 3 months after randomization

Title

Vascular events

Description

Recurrent vascular events including recurrent stroke, myocardial infarction or vascular death

Time Frame

At 3 months after randomization

Title

Hypotensive events

Description

Complaint of dizzy spells, falls or low-BP related events by patients

Time Frame

Until 3 months after randomization

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hee-Joon Bae, MD.PhD

Organizational Affiliation

Seoul National University Bundang Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Seoul National University Bundang Hospital

City

Seongnam

State/Province

Gyeonggi

ZIP/Postal Code

13520

Country

Korea, Republic of

Facility Name

Nowon Eulji Medical Center, Eulji University

City

Seoul

ZIP/Postal Code

01830

Country

Korea, Republic of

Facility Name

Seoul Medical Center

City

Seoul

ZIP/Postal Code

02053

Country

Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

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