Cilnidipine Effect on High Blood Pressure and Cerebral Perfusion in Ischemic Stroke Patients With Hypertension
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Multi-Center, Double Blind, Randomized and Non-Inferiority Clinical Study of Cilnidipine to Compare the Effects on Cerebral Blood Flow With Losartan in Patients With Ischemic Stroke Hypertension|
- the changes of global cerebral blood flow [ Time Frame: from screnning to weeks 4 ] [ Designated as safety issue: No ]
- The percentile change of regional CBF [ Time Frame: from screnning to weeks 4 ] [ Designated as safety issue: No ]
- The proportion of patients less than 8.6% decrease of global CBF [ Time Frame: from screnning to weeks 4 ] [ Designated as safety issue: No ]
- The change of NIHSS scores [ Time Frame: from screnning to weeks 4 ] [ Designated as safety issue: No ]
|Study Start Date:||January 2005|
|Study Completion Date:||August 2007|
|Primary Completion Date:||July 2007 (Final data collection date for primary outcome measure)|
Active Comparator: A,1,III
To compare the effect of cilnidipine (calcium channel blocker) and losartan (angiotension II receptor blocker) on CBF in patients with ischemic stroke
Cilnidipine 10~20mg, qd, po for 4 weeks.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00325637
|Korea, Republic of|
|Seoul National University Budang Hospital|
|Seongnam-si, Gyeonggi-do, Korea, Republic of|
|Principal Investigator:||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|
|Principal Investigator:||Yong S Lee, Professor||Seoul National University Boramae Hospital|
|Principal Investigator:||Dong W Kang, Assistant Professor||Asan Medical Center|