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| Name | Class |
|---|---|
| Daiichi Sankyo Korea Co., Ltd. | INDUSTRY |
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BOSS-Trial I is a phase 2 clinical trial with the following objectives;
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;
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intensive management arm | Experimental | Description:
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| Control arm | Active Comparator | Description:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral intensification | Behavioral | Suggested algorithm for behavioral intensification:
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| Measure | Description | Time Frame |
|---|---|---|
| Recruitment time to prespecified number of subjects | Difference in days between recruitment of the first subject and last subject | At 3 months after randomization |
| Retention of included participants | Ratio of completed subject over randomized subjects in each group | 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 | 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 | At 3 months after randomization |
| Control of blood pressure | ratio of subjects with well-controlled BP in each group | At 3 months after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of out-of-range measurement | Frequency of BP measurements out of the desirable BP range in a week | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hee-Joon Bae, MD.PhD | Seoul National University Bundang Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Seongnam-si | Gyeonggi-do | 13520 | South Korea | ||
| Nowon Eulji Medical Center, Eulji University |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 3, 2022 | |
| Reset | Feb 2, 2023 |
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| Pharmacological intensification based on olmesartan | Drug |
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| Bluetooth-equipped sphygmomanometer | Device |
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| At 3 months after randomization |
| Vascular events | Recurrent vascular events including recurrent stroke, myocardial infarction or vascular death | At 3 months after randomization |
| Hypotensive events | Complaint of dizzy spells, falls or low-BP related events by patients | Until 3 months after randomization |
| Seoul |
| 01830 |
| South Korea |
| Seoul Medical Center | Seoul | 02053 | South Korea |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 3, 2022 | Feb 2, 2023 |
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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