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

Recruiting

Phase 2 Results N/A

Trial Description

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

Interventions

  • Behavioral intensification Behavioral
    Intervention Desc: 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
    ARM 1: Kind: Experimental
    Label: Intensive management 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.
  • Pharmacological intensification based on olmesartan Drug
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Intensive management 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.
  • Bluetooth-equipped sphygmomanometer Device
    Intervention Desc: 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)
    ARM 1: Kind: Experimental
    Label: Intensive management 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.
    ARM 2: Kind: Experimental
    Label: Control arm
    Description: 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

Type Measure Time Frame Safety Issue
Primary Recruitment time to prespecified number of subjects At 3 months after randomization
Primary Retention of included participants At 3 months after randomization
Primary Frequencies of calls for breakthrough visit At 3 months after randomization
Primary Rate of patients who responded to the calls for breakthrough visit At 3 months after randomization
Primary Control of blood pressure At 3 months after randomization
Secondary Frequency of out-of-range measurement At 3 months after randomization
Secondary Weighted hit score of BP At 3 months after randomization
Secondary Vascular events At 3 months after randomization
Secondary Hypotensive events Until 3 months after randomization

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