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

PHASE2CompletedINTERVENTIONAL
Enrollment

67

Participants

Timeline

Start Date

September 1, 2016

Primary Completion Date

December 7, 2017

Study Completion Date

December 7, 2017

Conditions
Ischemic StrokeHypertension
Interventions
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)"

Trial Locations (3)

13520

Seoul National University Bundang Hospital, Seongnam-si

01830

Nowon Eulji Medical Center, Eulji University, Seoul

02053

Seoul Medical Center, Seoul

All Listed Sponsors
collaborator

Daiichi Sankyo Korea Co., Ltd.

INDUSTRY

lead

Seoul National University Bundang Hospital

OTHER

NCT03024476 - Optimization of Blood Pressure Management After Acute Ischemic Stroke and Its Prognostic Significance | Biotech Hunter | Biotech Hunter