Ischemic StrokePhase 2NCT03024476
Optimization of Blood Pressure Management After Acute Ischemic Stroke and Its Prognostic Significance
A Phase 2 study testing Behavioral intensification, Pharmacological intensification based on olmesartan and Bluetooth-equipped sphygmomanometer in people with Ischemic Stroke and Hypertension, run by Seoul National University Bundang Hospital at 3 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Ischemic Stroke, Hypertension
- What is being tested?
- Behavioral intensification, Pharmacological intensification based on olmesartan and Bluetooth-equipped sphygmomanometer
- Type of treatment
- Injection or infusion, Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 3 sitesSouth Korea
- Study dates
- 1 Sep 2016to 7 Dec 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
3 sites in 1 country.
South Korea3 sites
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13520
Nowon Eulji Medical Center, Eulji University
Seoul, 01830
Seoul Medical Center
Seoul, 02053
About this study
Official title: Optimization of Blood Pressure Management After Acute Ischemic Stroke and Its Prognostic Significance: Prospective, Randomized, Open, Blinded Outcome Evaluation, and Feasibility Trial
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.
Read the 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
- Being tested
- Behavioral intensification, Pharmacological intensification based on olmesartan, Bluetooth-equipped sphygmomanometer
- Keywords
- behavioral intervention, prespecified medication algorithm, bluetooth-equipped sphygmomanometer
- Medical subject headings
- Ischemic Stroke, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral intensificationBehavioural
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 olmesartanDrug
- 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 sphygmomanometerDevice
- 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)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Device: Bluetooth-equipped sphygmomanometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment time to prespecified number of subjects
Difference in days between recruitment of the first subject and last subject
Measured: At 3 months after randomization
Retention of included participants
Ratio of completed subject over randomized subjects in each group
Measured: 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
Measured: 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
Measured: At 3 months after randomization
Control of blood pressure
ratio of subjects with well-controlled BP in each group
Measured: At 3 months after randomization
Secondary outcomes (4)
Frequency of out-of-range measurement
Frequency of BP measurements out of the desirable BP range in a week
Measured: At 3 months after randomization
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
Measured: At 3 months after randomization
Vascular events
Recurrent vascular events including recurrent stroke, myocardial infarction or vascular death
Measured: At 3 months after randomization
Hypotensive events
Complaint of dizzy spells, falls or low-BP related events by patients
Measured: Until 3 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2017 (estimated)
- Study start1 Sep 2016
- Primary completion7 Dec 2017
- Study completion7 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Daiichi Sankyo Korea Co., Ltd.
- Responsible party
- Principal investigator, Hee-Joon Bae, Seoul National University Bundang Hospital
- Investigators
- Hee-Joon Bae, MD.PhD, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03024476
- Sponsor's protocol ID
- B-1604/343
- Status last verified
- Apr 2018
- First submitted
- 3 Jan 2017
- Last updated
- 6 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Blood Pressure Management After Acute Ischemic Stroke and Its Prognostic Significance: Prospective, Randomized, Open, Blinded Outcome Evaluation, and Feasibility Trial
- ClinicalTrials.gov ID
- NCT03024476
- Acronym / sponsor ID
- B-1604/343
- Conditions
- Ischemic Stroke, Hypertension
- Keywords
- behavioral intervention, prespecified medication algorithm, bluetooth-equipped sphygmomanometer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Collaborators
- Daiichi Sankyo Korea Co., Ltd.
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 7 Dec 2017 (actual)
- Study completion
- 7 Dec 2017 (actual)
- First posted
- 18 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive management arm | Experimental | Behavioral: Behavioral intensification, Drug: Pharmacological intensification based on olmesartan, Device: Bluetooth-equipped sphygmomanometerDescription: * 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. |
| Control arm | Active comparator | Device: Bluetooth-equipped sphygmomanometerDescription: * 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). |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral intensificationSuggested 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 | Behavioural | Intensive management arm |
| 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. | Drug | Intensive management arm |
| 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) | Device | Control arm, Intensive management arm |
Primary outcome
Recruitment time to prespecified number of subjects
Time frame: At 3 months after randomization
Difference in days between recruitment of the first subject and last subject
Retention of included participants
Time frame: At 3 months after randomization
Ratio of completed subject over randomized subjects in each group
Frequencies of calls for breakthrough visit
Time frame: At 3 months after randomization
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
Time frame: At 3 months after randomization
ratio of subjects response over the breakthrough visit calls
Control of blood pressure
Time frame: At 3 months after randomization
ratio of subjects with well-controlled BP in each group
4 secondary outcomes
Frequency of out-of-range measurement
Time frame: At 3 months after randomization
Weighted hit score of BP
Time frame: At 3 months after randomization
Vascular events
Time frame: At 3 months after randomization
Hypotensive events
Time frame: Until 3 months after randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hee-Joon Bae, MD.PhD principal investigator
Seoul National University Bundang Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Behavioral intensification, Pharmacological intensification based on olmesartan and Bluetooth-equipped sphygmomanometer in people with Ischemic Stroke and Hypertension, run by Seoul National University Bundang Hospital at 3 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment time to prespecified number of subjects (time frame: At 3 months after randomization). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2018.