Valsartan Efficacy on Modest Blood Pressure Reduction in Acute Ischemic Stroke (VENTURE)
Recruitment status was Recruiting
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Death or dependency measured as functional status with the use of mRDs [ Time Frame: 90 days after the onset ] [ Designated as safety issue: No ]
- NIHSS [ Time Frame: 7 days and 90 days after stroke onset ] [ Designated as safety issue: No ]
|Study Start Date:||October 2008|
|Estimated Study Completion Date:||July 2012|
|Primary Completion Date:||July 2011 (Final data collection date for primary outcome measure)|
Experimental: valsartan group
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.
Drug: Diovan® (valsartan)
The valsartan 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.
In those patients not achieving target level of blood pressure (more than 15% reduction of initial blood pressure or below 145 mmHg of systolic blood pressure), an additional antihypertensive drugs (diuretics, beta blockers) can be given despite of Valsartan 320 mg. If the BP is considered to be low enough, dose of valsartan can be decreased to 40 mg per day. If the administration of valsartan is judged to be inappropriate by duty doctor due to any reasons, it can be stopped and the reasons will be recorded.
No Intervention: control group
Patients on control group will not receive any other antihypertensive medication for first 7 days after stroke onset. However, rescue therapy with antihypertensive agents can be permitted for episodes with severely elevated blood pressures during acute periods.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00874601
|Contact: Byung-chul Lee, MD, PhDfirstname.lastname@example.org|
|Contact: Kyung-ho Yu, MD, PhDemail@example.com|
|Korea, Republic of|
|Hallym University Sacred Heart Hospital||Recruiting|
|Anyang, Gyeonggi, Korea, Republic of, 430-070|
|Contact: Byung-chul Lee, MD, PhD +82-31-380-3741 firstname.lastname@example.org|
|Sub-Investigator: Kyung-ho Yu, MD, PhD|
|Principal Investigator:||Byung-chul Lee, MD, PhD||Hallym University Medical Center|