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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by Hallym University Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Hallym University Medical Center
ClinicalTrials.gov Identifier:
NCT00874601
First received: April 1, 2009
Last updated: October 4, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention Phase
Acute Ischemic Stroke
Drug: Diovan® (valsartan)
Phase 4

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Hallym University Medical Center:

Primary Outcome Measures:
  • Death or dependency measured as functional status with the use of mRDs [ Time Frame: 90 days after the onset ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • NIHSS [ Time Frame: 7 days and 90 days after stroke onset ] [ Designated as safety issue: No ]

Estimated Enrollment: 578
Study Start Date: October 2008
Estimated Study Completion Date: July 2012
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00874601

Contacts
Contact: Byung-chul Lee, MD, PhD +82-31-380-3841 ssbrain@hallym.ac.kr
Contact: Kyung-ho Yu, MD, PhD +82-31-380-3843 ykh1030@hallym.ac.kr

Locations
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    ssbrain@hallym.ac.kr   
Sub-Investigator: Kyung-ho Yu, MD, PhD         
Sponsors and Collaborators
Hallym University Medical Center
Investigators
Principal Investigator: Byung-chul Lee, MD, PhD Hallym University Medical Center
  More Information

No publications provided

Responsible Party: Hallym University Medical Center
ClinicalTrials.gov Identifier: NCT00874601     History of Changes
Other Study ID Numbers: VENTURE
Study First Received: April 1, 2009
Last Updated: October 4, 2011
Health Authority: South Korea: Institutional Review Board

Keywords provided by Hallym University Medical Center:
acute ischemic stroke
blood pressure
valsartan
death
dependancy

Additional relevant MeSH terms:
Ischemia
Stroke
Cerebral Infarction
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia
Valsartan
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 16, 2014