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

Completed

Phase 3 Results

Trial Description

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.

Conditions

Interventions

  • Losartan (Cozaar)Drug
    Other Names: losartan potassium; COZAAR®; MK0954
    Intervention Desc: is an angiotensin II receptor antagonist drug used mainly to treat high blood pressure (hypertension).
  • cilnidipine Drug
    Other Names: Arms: Losartan, Cilnidipine; Cinalong
    Intervention Desc: Cilnidipine 10~20mg, qd, po for 4 weeks.
    ARM 1: Kind: Experimental
    Label: A,1,III
    Description: To compare the effect of cilnidipine (calcium channel blocker) and losartan (angiotension II receptor blocker) on CBF in patients with ischemic stroke

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Patient Involvement

After 2-week washout period, we measured baseline 99mTc-HMPAO single photon emission computed tomography (SPECT), blood pressure (BP), NIHSS, and laboratory tests. Then, the patients were randomized to receive either cilnidipine 10–20 mg or losartan 50–100 mg once daily for 4 weeks with a target systolic blood pressure of <140mmHg and diastolic blood pressure of <90mmHg. The final 99mTc-HMPAO SPECT and BP measurements were obtained at 4 weeks. In order to standardize SPECT measurements, all patients were transferred to a single center for SPECT evaluation using a single machine (ADAC Forte, ADAC Laboratories;APhilips Medical Systems Company, Milpitas, CA, USA)

Outcomes

Type Measure Time Frame Safety Issue
Primary Global CBF change as measured quantitatively.
Secondary 1) CBF change in the hemisphere ipsilateral to the index stroke, 2) non-impairment of global CBF as determined by less than 8.6% decrease of global CBF, and 3) BP reduction.
Primary the changes of global cerebral blood flow from screnning to weeks 4 No
Secondary The percentile change of regional CBF from screnning to weeks 4 No
Secondary The proportion of patients less than 8.6% decrease of global CBF from screnning to weeks 4 No
Secondary The change of NIHSS scores from screnning to weeks 4 No

Sponsors