Clinical trial NCT00325637: Cilnidipine Effect on High Blood Pressure and Cerebral Perfusion in Ischemic Stroke Patients With Hypertension
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Stroke
Keywords: CHERISH
Ischemic Stroke
Lead sponsor: Boryung Pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2006-05-15
Enrollment: 250
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Ischemic stroke patients with hypertension

Exclusion Criteria:

* Cardioembolic stroke patients
* Severe hypertensive patients
* Secondary hypertensive patients

Primary outcomes:
measure: the changes of global cerebral blood flow
timeFrame: from screnning to weeks 4
Secondary outcomes:
measure: The percentile change of regional CBF
timeFrame: from screnning to weeks 4
measure: The proportion of patients less than 8.6% decrease of global CBF
timeFrame: from screnning to weeks 4
measure: The change of NIHSS scores
timeFrame: from screnning to weeks 4
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Budang Hospital
state: Gyeonggi-do
Study officials:
affiliation: Seoul National University Budang Hospital
name: Seong H Park, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Inha University Hospital
name: Jeong H Rha, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Eulji General Hospital
name: Ja S Koo, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Inje University Ilsan Paik Hospital
name: Keun S Hong, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Seoul National University Boramae Hospital
name: Yong S Lee, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Asan Medical Center
name: Dong W Kang, Assistant Professor
role: PRINCIPAL_INVESTIGATOR
References: