Valsartan Efficacy on Modest Blood Pressure Reduction in Acute Ischemic Stroke

Condition(s) targeted: Acute Ischemic Stroke

Intervention: Diovan® (valsartan) (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Hallym University Medical Center

Official(s) and/or principal investigator(s):
Byung-chul Lee, MD, PhD, Principal Investigator, Affiliation: Hallym University Medical Center

Overall contact:
Byung-chul Lee, MD, PhD, Phone: +82-31-380-3841, Email: ssbrain@hallym.ac.kr

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.

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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Death or dependency measured as functional status with the use of mRDs

Secondary outcome: NIHSS

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Byung-chul Lee, MD, PhD, Phone: +82-31-380-3841, Email: ssbrain@hallym.ac.kr

Hallym University Sacred Heart Hospital, Anyang, Gyeonggi 430-070, Korea, Republic of; Recruiting
Byung-chul Lee, MD, PhD, Phone: +82-31-380-3741, Email: ssbrain@hallym.ac.kr
Kyung-ho Yu, MD, PhD, Sub-Investigator

Starting date: October 2008
Last updated: October 4, 2011