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Valsartan Efficacy on Modest Blood Pressure Reduction in Acute Ischemic Stroke (VENTURE)

Primary Purpose

Acute Ischemic Stroke

Status

Unknown status

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Diovan® (valsartan)

About this trial

This is an interventional treatment trial for Acute Ischemic Stroke focused on measuring acute ischemic stroke, blood pressure, valsartan, death, dependancy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hallym University Sacred Heart HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

valsartan group

control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

NIHSS

Full Information

NCT ID

NCT00874601

First Posted

April 1, 2009

Last Updated

October 4, 2011

Sponsor

Hallym University Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT00874601

Brief Title

Valsartan Efficacy on Modest Blood Pressure Reduction in Acute Ischemic Stroke

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2011

Overall Recruitment Status

Unknown status

Study Start Date

October 2008 (undefined)

Primary Completion Date

July 2011 (Actual)

Study Completion Date

July 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hallym University Medical Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Ischemic Stroke

Keywords

acute ischemic stroke, blood pressure, valsartan, death, dependancy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

578 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

valsartan group

Arm Type

Experimental

Arm Description

Arm Title

control group

Arm Type

No Intervention

Arm Description

Intervention Type

Drug

Intervention Name(s)

Diovan® (valsartan)

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Time Frame

90 days after the onset

Secondary Outcome Measure Information:

Title

NIHSS

Time Frame

7 days and 90 days after stroke onset

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Byung-chul Lee, MD, PhD

Phone

+82-31-380-3841

ssbrain@hallym.ac.kr

First Name & Middle Initial & Last Name or Official Title & Degree

Kyung-ho Yu, MD, PhD

Phone

+82-31-380-3843

ykh1030@hallym.ac.kr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Byung-chul Lee, MD, PhD

Organizational Affiliation

Hallym University Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hallym University Sacred Heart Hospital

City

Anyang

State/Province

Gyeonggi

ZIP/Postal Code

430-070

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Byung-chul Lee, MD, PhD

Phone

+82-31-380-3741

ssbrain@hallym.ac.kr

First Name & Middle Initial & Last Name & Degree

Kyung-ho Yu, MD, PhD

12. IPD Sharing Statement

Citations:

PubMed Identifier

24957314

Citation

Park TH, Lee JS, Park SS, Ko Y, Lee SJ, Lee KB, Lee J, Kang K, Park JM, Choi JC, Kim DE, Cho YJ, Kim JT, Kim DH, Cha JK, Han MK, Lee J, Oh MS, Yu KH, Lee BC, Bae HJ, Hong KS. Safety and efficacy of intravenous recombinant tissue plasminogen activator administered in the 3- to 4.5-hour window in Korea. J Stroke Cerebrovasc Dis. 2014 Aug;23(7):1805-12. doi: 10.1016/j.jstrokecerebrovasdis.2014.04.027. Epub 2014 Jun 21.

Results Reference

derived

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Valsartan Efficacy on Modest Blood Pressure Reduction in Acute Ischemic Stroke

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