Status:
UNKNOWN
Valsartan Efficacy on Modest Blood Pressure Reduction in Acute Ischemic Stroke
Lead Sponsor:
Hallym University Medical Center
Conditions:
Acute Ischemic Stroke
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 affec...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2012
Estimated Enrollment :
578 Patients enrolled
Trial Details
Trial ID
NCT00874601
Start Date
October 1 2008
End Date
July 1 2012
Last Update
October 5 2011
Active Locations (1)
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1
Hallym University Sacred Heart Hospital
Anyang-si, Gyeonggi-do, South Korea, 430-070