Clinical trial NCT00874601: Valsartan Efficacy on Modest Blood Pressure Reduction in Acute Ischemic Stroke
Official title: Prospective, Randomized, Open-label, Blinded Endpoints, Multi-center Study to Evaluate the Efficacy of Modest Blood Pressure Reduction With Diovan® (Valsartan) in Acute Ischemic Stroke
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Acute Ischemic Stroke
Keywords: acute ischemic stroke
blood pressure
valsartan
death
dependancy
Lead sponsor: Hallym University Medical Center
Sponsor class: OTHER
First posted: 2009-04-02
Enrollment: 578
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Death or dependency measured as functional status with the use of mRDs
timeFrame: 90 days after the onset
Secondary outcomes:
measure: NIHSS
timeFrame: 7 days and 90 days after stroke onset
Other outcomes:
Locations:
city: Anyang
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital
state: Gyeonggi
Study officials:
affiliation: Hallym University Medical Center
name: Byung-chul Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Park TH, Lee JS, Park SS, Ko Y, Lee SJ, Lee KB, Lee J, Kang K, Park JM, Choi JC, Kim DE, Cho YJ, Kim JT, Kim DH, Cha JK, Han MK, Lee J, Oh MS, Yu KH, Lee BC, Bae HJ, Hong KS. Safety and efficacy of intravenous recombinant tissue plasminogen activator administered in the 3- to 4.5-hour window in Korea. J Stroke Cerebrovasc Dis. 2014 Aug;23(7):1805-12. doi: 10.1016/j.jstrokecerebrovasdis.2014.04.027. Epub 2014 Jun 21.