Valsartan Efficacy on Modest Blood Pressure Reduction in Acute Ischemic Stroke

Phase 4

• Conditions: Acute Ischemic Stroke
• Interventions: Drug: Diovan® (valsartan)

• Registration Number: NCT00874601
• Lead Sponsor: Hallym University Medical Center

Brief Summary

The manipulation of blood pressure in acute cerebral ischemia has been a matter of debate until now. The investigators are clearly in need of more detailed data on how antihypertensive treatment affects outcome in acute phase of stroke.

This study will assess the effects of modest blood pressure (BP) lowering manipulation in acute period of ischemic stroke on death or dependency at 90-day.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2009-04-01
• Study First Submitted QC: 2009-04-01
• Study First Posted: 2009-04-02
• Primary Completion: 2011-07
• Status Verified: 2011-10
• Last Update Submitted: 2011-10-04
• Last Update Posted: 2011-10-05
• Study Completion: 2012-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 578

Inclusion Criteria

• Age over 18 years
• Patients admitted within 24 hours and can be enrolled within 48 hours after qualifying ischemic stroke onset
• Patients with systolic blood pressure above 150 mm Hg and no more than 185 mm Hg at least twice of 3 or more times at 5 minutes intervals after resting
• Baseline NIHSS score at least 2 points, not more than 21 points
• Full functional independence prior to the present stroke indicated by an estimated premorbid mRS score of 0 or 1
• Informed consent from the patients or authorized representatives must be obtained in writing enrollment into the study

Exclusion Criteria

• Patients who received thrombolytic therapy (intravenous or intraarterial)
• Patients with acute Intracerebral hemorrhage diagnosed by neuroimaging
• Patients with moderate or severe cardiac failure (New York Heart Association class III and IV)
• Patients with medical condition which need urgent or special antihypertentive therapy, such as hypertensive encephalopathy, aortic dissection, acute renal failure, acute pulmonary edema, or acute myocardial infarction
• Comatose at screening
• Known or suspected cerebral aneurysm or arteriovenous malformation
• Any other clinical relevant serious disease, including uncontrolled Diabetes, severe liver disease, or severe renal disease at the time of randomization
• Life expectancy of less than 3 months due to comorbid conditions, such as malignancy
• Participation in another drug trials or planned use of vascular interventions within the previous 30 days
• Women who are pregnant, breast feeding, or of child bearing potentials
• Contraindication to ARBs, such as history of angioedema to ARBs, renovascular hypertension

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
valsartan group	Diovan® (valsartan)	The valsartan group will be initially given 80 mg of Diovan® (valsartan) per oral once daily in the morning on day 1, and flexibly will be adjusted to a dose of 80 -320 mg per day during next 6 days if more than 30% of SBPs measured at least 4 times in a day will not get the target level of SBPs.

Primary Outcome Measures

Name	Time	Method
Death or dependency measured as functional status with the use of mRDs	90 days after the onset

Secondary Outcome Measures

Name	Time	Method
NIHSS	7 days and 90 days after stroke onset

Trial Locations

Locations (1)

Hallym University Sacred Heart Hospital; 🇰🇷 Anyang, Gyeonggi, Korea, Republic of