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Blood Pressure Lowering in Acute Stroke Trial (BLAST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00627991
Recruitment Status : Withdrawn
First Posted : March 4, 2008
Last Update Posted : April 14, 2016
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Gregory W Albers, Stanford University

Brief Summary:
Patients who are suffering from a stroke often present to the hospital with elevated blood pressure. Elevated blood pressure in the setting of stroke increases the risk of brain swelling or bleeding into the brain. Even so, there has been concern about lowering the blood pressure with medications because the newly injured parts of the brain may not get the blood flow they need, thereby worsening the damage from the initial stroke. We hope to demonstrate that the drug valsartan can be used safely and modestly to lower blood pressure in acute stroke patients, without having a detrimental effect on brain blood flow or neurologic status. Novel MRI techniques to measure brain blood flow will be used in conjunction with clinical scales to demonstrate safety.

Condition or disease Intervention/treatment Phase
Cerebrovascular Accident Drug: Valsartan Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: The Use of Valsartan for the Management of Blood Pressure in Acute Stroke: Effects on Cerebral Blood Flow.
Study Start Date : August 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Valsartan

Primary Outcome Measures :
  1. 30 day glascow outcome score
  2. 30 day modified Rankin

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Men and non-pregnant women over age 18 who have had an acute ischemic stroke referable to the anterior circulation, as diagnosed by one of more of the following: clinical judgment, head CT, and/or MR imaging [i.e. a positive diffusion-weighted imaging (DWI) abnormality].
  2. Clinical syndrome not likely to represent transient ischemic attack (TIA) or other non-stroke etiology
  3. Patient must be neurologically stable at the time of first MRI scan (i.e. stable NIH Stroke Scale score).
  4. Initial MRI scan obtainable within 48 hours of symptom onset.
  5. A pre-existing diagnosis of hypertension, either treated or untreated.
  6. Average of two mean arterial blood pressures (separated by at least five minutes) at time of enrollment.

Exclusion Criteria:

  1. Patients who have taken an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) within seven (7) days of admission.
  2. Patients who received intravenous or intra-arterial r-TPA for their current symptoms, or those who underwent mechanical thrombolysis.
  3. Patients with hemorrhagic strokes, as seen on the initial head CT.
  4. Patients with stroke-like symptoms, but no demonstrable lesion on DWI, or a DWI lesion < 2 cm in diameter (greatest dimension).
  5. Patients with high-grade (>70%) internal carotid artery stenosis or occlusion ipsilateral to the current stroke.
  6. Patients with high-grade aortic or mitral stenosis.
  7. Patients with a previous adverse reaction to valsartan or other ARBs.
  8. Patients with contraindications for MRI, including pacemakers, claustrophobia, or severe obesity.
  9. Patients who are medically unstable for MR imaging, as determined by the treating team.
  10. Patients with a severe co-existing disease that may interfere with the conduct of the study.
  11. Patients receiving investigational drug therapies.
  12. Informed consent cannot be obtained from the patient or an appropriate surrogate.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00627991

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United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Novartis Pharmaceuticals
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Principal Investigator: Gregory W Albers Stanford University
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Responsible Party: Gregory W Albers, Principle Investigator, Stanford University Identifier: NCT00627991    
Other Study ID Numbers: SU-01282008-990
First Posted: March 4, 2008    Key Record Dates
Last Update Posted: April 14, 2016
Last Verified: April 2016
Additional relevant MeSH terms:
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Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action