Blood Pressure Lowering in Acute Stroke Trial

NCT01400256 | Withdrawn Phase 4 DMC

• 1 other identifier: CVAL489A US71
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators hope to show that valsartan can be used safely in the setting of acute stroke to lower elevated blood pressure. There are novel properties of this class of drug (an angiotensive-receptor blocker or ARB), and promising human and animal data, that would suggest this drug can be safely used to lower blood pressure in the setting of acute stroke without compromising brain blood flow (i.e. cerebral perfusion). If this is proved to be the case, this compound could potentially be used routinely in this setting, with the hope of improving outcome. This pilot study may pave the way for a larger randomized trial looking at outcome measures in stroke patients. Further, a positive result in the this pilot study will serve as proof of concept that ARBs maintain cerebral perfusion while decreasing blood pressure, an overall favorable property.

Conditions

Stroke, Acute

Keywords

diagnostic

Interventions

Valsartan DRUG

After the initial MRI, patients will be given a 160 mg dose of valsartan or placebo, in a double-blinded fashion. A sustained MAP reduction of 15-20% will be the goal. If the MAP remains within 15% of the initial value (prior to the first MRI scan) 24 hours after the first dose of valsartan (or placebo), the patients will be given a 320 mg dose of valsartan (or placebo) and will remain on valsartan 320 mg (or placebo) daily until day 7, or hospital discharge (whichever is sooner). If the MAP is falls by more than 20% after the 160 mg (or placebo) dose, the patient will be switched to 80 mg of valsartan (or placebo) until day 7, or hospital discharge (whichever is sooner). If the blood pressure is lowered by 15-20% (the goal), the patients will remain on valsartan 160 mg (or placebo) daily for the duration of the study.

Eligibility Criteria

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

You may qualify if:

• 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 \[i.e. a positive diffusion-weighted imaging (DWI) abnormality\].
• Clinical syndrome not likely to represent transient ischemic attack (TIA) or other non-stroke etiology
• Patient must be neurologically stable at the time of first MRI scan (i.e. stable NIH Stroke Scale score).
• Initial MRI scan obtainable within 48 hours of symptom onset.
• A pre-existing diagnosis of hypertension, either treated or untreated.
• Average of two mean arterial blood pressures (separated by at least five minutes) at time of initial MRI scan ≥ 110.

You may not qualify if:

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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University Medical Center

Stanford, California, 94304, United States

Location

MeSH Terms

Conditions

Stroke; Disease

Interventions

Valsartan

Condition Hierarchy (Ancestors)

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

• Gregory Albers, M.D

  Stanford University

  PRINCIPAL INVESTIGATOR

• Neil Schwartz, M.D

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: July 20, 2011
• First Posted: July 22, 2011
• Study Start: August 1, 2007
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: May 9, 2016

Record last verified: 2016-05

Locations

US (1)