NCT00874601

Valsartan Efficacy on Modest Blood Pressure Reduction in Acute Ischemic Stroke

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 578 (estimated)
• Sponsor: Hallym University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Ischemic Stroke

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2008-10-01
• Primary completion: 2011-07-01
• Completion: 2012-07-01
• First posted: 2009-04-02
• Last updated: 2011-10-05

Locations

1 site across 1 country: South Korea