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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03024476
• Other study ID #: B-1604/343
• Status: Completed
• Phase: Phase 2
• First received: January 3, 2017
• Last updated: April 4, 2018
• Start date: September 1, 2016
• Est. completion date: December 7, 2017

Study information

• Verified date: April 2018
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: December 7, 2017
• Est. primary completion date: December 7, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Infarction
• Hypertension
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Behavioral:
• Behavioral intensification
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

Drug:
• 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.

Device:
• 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)

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Gyeonggi
Korea, Republic of	Nowon Eulji Medical Center, Eulji University	Seoul
Korea, Republic of	Seoul Medical Center	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital	Daiichi Sankyo Korea Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment time to prespecified number of subjects	Difference in days between recruitment of the first subject and last subject	At 3 months after randomization
Primary	Retention of included participants	Ratio of completed subject over randomized subjects in each group	At 3 months after randomization
Primary	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
Primary	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
Primary	Control of blood pressure	ratio of subjects with well-controlled BP in each group	At 3 months after randomization
Secondary	Frequency of out-of-range measurement	Frequency of BP measurements out of the desirable BP range in a week	At 3 months after randomization
Secondary	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	At 3 months after randomization
Secondary	Vascular events	Recurrent vascular events including recurrent stroke, myocardial infarction or vascular death	At 3 months after randomization
Secondary	Hypotensive events	Complaint of dizzy spells, falls or low-BP related events by patients	Until 3 months after randomization