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Completed

NCT Number: NCT03024476

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

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.

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Key information

Conditions

Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hypertension Nervous System Diseases Stroke Vascular Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Seoul National University Bundang Hospital, Seongnam-si, Gyeonggi-do, South Korea

Loading trial locations.

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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.

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)

Primary outcomes

  1. 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

  2. Retention of included participants

    Time frame: At 3 months after randomization

    Ratio of completed subject over randomized subjects in each group

  3. 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

  4. 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

  5. Control of blood pressure

    Time frame: At 3 months after randomization

    ratio of subjects with well-controlled BP in each group

Secondary outcomes

  1. Frequency of out-of-range measurement

    Time frame: At 3 months after randomization

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

  2. Weighted hit score of BP

    Time frame: At 3 months after randomization

    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

  3. Vascular events

    Time frame: At 3 months after randomization

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

  4. Hypotensive events

    Time frame: Until 3 months after randomization

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

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Collaborators

  • Daiichi Sankyo Korea Co., Ltd.

Registry information

Official study title

Optimization of Blood Pressure Management After Acute Ischemic Stroke and Its Prognostic Significance: Prospective, Randomized, Open, Blinded Outcome Evaluation, and Feasibility Trial

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jan 18, 2017
Registry last updated
Apr 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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