Valsartan Efficacy on Modest Blood Pressure Reduction in Acute Ischemic Stroke

NCT00874601 | Unknown Phase 4 DMC

• 1 other identifier: VENTURE
• Study Type: interventional
• Target: 578
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Ischemic Stroke

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  90 days after the onset

Secondary Outcomes (1)

• NIHSS

  7 days and 90 days after stroke onset

Study Arms (2)

valsartan group

EXPERIMENTAL

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)

control group

NO INTERVENTION

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.

Interventions

Diovan® (valsartan) DRUG

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.

valsartan group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hallym University Medical Center: lead

Study Sites (1)

Hallym University Sacred Heart Hospital

Anyang-si, Gyeonggi-do, 430-070, South Korea

RECRUITING

Related Publications (1)

• 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.

  PMID: 24957314 DERIVED

MeSH Terms

Conditions

Ischemic Stroke; Death

Interventions

Valsartan

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Valine; Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential

Study Officials

• Byung-chul Lee, MD, PhD

  Hallym University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Byung-chul Lee, MD, PhD

CONTACT

+82-31-380-3841; ssbrain@hallym.ac.kr

Kyung-ho Yu, MD, PhD

CONTACT

+82-31-380-3843; ykh1030@hallym.ac.kr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2009
• First Posted: April 2, 2009
• Study Start: October 1, 2008
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2012
• Last Updated: October 5, 2011

Record last verified: 2011-10

Locations

KR (1)