Valsartan Efficacy on Modest Blood Pressure Reduction in Acute Ischemic Stroke

Acute Ischemic Stroke Clinical Trial

— VENTURE  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00874601
• Other study ID #: VENTURE
• Status: Recruiting
• Phase: Phase 4
• First received: April 1, 2009
• Last updated: October 4, 2011
• Start date: October 2008
• Est. completion date: July 2012

Study information

• Verified date: October 2011
• Source: Hallym University Medical Center
• Contact: Byung-chul Lee, MD, PhD
• Phone: +82-31-380-3841
• Email: ssbrain[@]hallym.ac.kr
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 578
• Est. completion date: July 2012
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Ischemia
• Stroke

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Hallym University Sacred Heart Hospital	Anyang	Gyeonggi

Sponsors (1)

Lead Sponsor	Collaborator
Hallym University Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death or dependency measured as functional status with the use of mRDs		90 days after the onset	No
Secondary	NIHSS		7 days and 90 days after stroke onset	No