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| ID | Type | Description | Link |
|---|---|---|---|
| CHERISH Study |
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The purpose of this study is to compare the effect of cilnidipine (a calcium channel blocker) and losartan (an angiotensin II receptor blocker) on cerebral blood flow (CBF) and blood pressure in hypertensive patients with a previous ischemic stroke.
Design: Multi-center, randomized, double-blind, active control, titrated dose, non-inferiority trial
Population Studied: We will prospectively recruit 250 hypertensive patients who had ischemic stroke 2 or more weeks previously and were admitted at 7 centers in the Seoul metropolitan area in South Korea.
Interventions: After a 2-week washout period, all patients will undergo baseline 99mTc-HMPAO single photon emission computed tomography (SPECT), blood pressure evaluation, NIHSS examination, and laboratory test prior to treatment. The patients will be randomized to receive either cilnidipine 10-20mg or losartan 50-100mg once daily for 4 weeks with a target systolic blood pressure of < 140mmHg and diastolic blood pressure of < 90mmHg. After 4-week treatment, all patients will receive follow-up SPECT and blood pressure evaluation. For the quantitative CBF analysis, SPECT will be performed with a single machine in one center.
Outcome Measures: Primary outcome measure is the percentile change of global CBF on SPECT between pre- and post-treatments. Secondary outcome measures include the percentile change of regional CBF, the proportion of patients less than 8.6% decrease of global CBF, and the change of NIHSS score.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A,1,III | Active Comparator | To compare the effect of cilnidipine (calcium channel blocker) and losartan (angiotension II receptor blocker) on CBF in patients with ischemic stroke |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cilnidipine | Drug | Cilnidipine 10~20mg, qd, po for 4 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| the changes of global cerebral blood flow | from screnning to weeks 4 |
| Measure | Description | Time Frame |
|---|---|---|
| The percentile change of regional CBF | from screnning to weeks 4 | |
| The proportion of patients less than 8.6% decrease of global CBF | from screnning to weeks 4 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Seong H Park, Professor | Seoul National University Budang Hospital | Principal Investigator |
| Jeong H Rha, Professor | Inha University Hospital | Principal Investigator |
| Ja S Koo, Professor | Eulji General Hospital | Principal Investigator |
| Keun S Hong, Professor | Inje University Ilsan Paik Hospital | Principal Investigator |
| Yong S Lee, Professor | Seoul National University Boramae Hospital | Principal Investigator |
| Dong W Kang, Assistant Professor | Asan Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Budang Hospital | Seongnam-si | Gyeonggi-do | South Korea |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D020521 | Stroke |
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
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| ID | Term |
|---|---|
| C065927 | cilnidipine |
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| The change of NIHSS scores |
| from screnning to weeks 4 |
| D002493 |
| Central Nervous System Diseases |
| D009422 | Nervous System Diseases |