Blood Pressure Lowering in Acute Stroke Trial (BLAST)

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT00627991
First received: February 22, 2008
Last updated: July 20, 2011
Last verified: July 2011
  Purpose

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 Intervention
Cerebrovascular Accident
Drug: Valsartan

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: The Use of Valsartan for the Management of Blood Pressure in Acute Stroke: Effects on Cerebral Blood Flow.

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • 30 day glascow outcome score
  • 30 day modified Rankin

Estimated Enrollment: 20
Study Start Date: August 2007
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00627991

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Novartis Pharmaceuticals
Investigators
Principal Investigator: Gregory W Albers Stanford University
  More Information

No publications provided

Responsible Party: Gregory W Albers, Principal Investigator, Stanford University School of Medicine
ClinicalTrials.gov Identifier: NCT00627991     History of Changes
Other Study ID Numbers: SU-01282008-990, 7599
Study First Received: February 22, 2008
Last Updated: July 20, 2011
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 17, 2014