Stroke Trials Registry

CHERISH
Cilnidipine Effect on High Blood Pressure and Cerebral Perfusion in Ischemic Stroke Patients with Hypertension

Principal Investigator
Seong-Ho Park, MD, PhD

PI Address
Seong-Ho Park, MD, PhD
Phone: 82-31-787-7461

Email: nrpsh@snu.ac.kr

Contact Address
Keun-Sik Hong
Co-investigator of CHERISH trial
Associate Professor/Chairman of Neurology
Department of Neurology
Ilsan Paik Hospital
Inje University

Tell: 82-31-910-7680
Fax: 82-31-910-7368

Contact Email
nrhks@ilsanpaik.ac.kr

Sponsor

Study Size Actual:	110
Study Size Planned:	250
Centers Actual:	6
Max Time from onset:	2 Weeks
Max Age:	80
Min Age:	35
Follow-up Duration:	4 Weeks
ISRCTN#	NCT00325637

Status:
Complete. Enrollment is complete and data is being analyzed. Results were presented at regional international conference July this year. Currently the article is being prepared for publication.

Purpose:
To compare the effect of cilnidipine (calcium channel blocker) and losartan (angiotensin II receptor blocker) on CBF and blood pressure in hypertensive patients with previous ischemic stroke.

Interventions:

cilnidipine
Cilnidipine (INN) is a calcium channel blocker.

Losartan
is an angiotensin II receptor antagonist drug used mainly to treat high blood pressure (hypertension).

Location(s):
South Korea

Year Started: 2005

Year Finished: 2007

Year Published: 2009

Design:
Multi-center, randomized, double-blind, active control, titrated dose, non-inferiority trial.

Inclusion Criteria
Ischemic stroke patients with hypertension previously from the Seoul metropolitan region in South Korea.

Exclusion Criteria
Cardioembolic stroke patients; severe hypertensive patients;
secondary hypertensive patients.

Patient Involvement:
After 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, blood pressure evaluation, and NIHSS examination. For the quantitative CBF analysis, SPECT will be performed with a single machine in one center.

Primary Outcome:
Percentile change of global CBF on SPECT between pre- and post-treatments.

Secondary Outcome:
Percentile change of regional CBF, the proportion of patients less than 8.6% decrease of global CBF, and the change of NIHSS score.

Results:
Data is being analyzed and results are expected in March 2008.

Comments:
CNL-BR3-01-02
"Effect of cilnidipine versus losartan on cerebral blood flow in hypertensive patients with a history of ischemic stroke: A randomized controlled trial" accepted for publication in Acta Neurologica Scandinavica October, 2009.

Source of Information:
Presented at the 2006 International Stroke Conference [February 2006.]
ClinicalTrials.gov

Web Links and Publications:

Boryung Pharmaceutical

CHERISH
ClinicalTrials.gov

This information last updated on: 10/26/2009

Reviewed on: 11/11/2009.

UID: 685