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Blood Pressure Lowering in Acute Stroke Trial

NCT01400256 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2016-05-09

No results posted yet for this study

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

Interventions

DRUG

Valsartan

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.

Sponsors & Collaborators

Principal Investigators

  • Gregory Albers, M.D · Stanford University

  • Neil Schwartz, M.D · Stanford University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-08-31
Primary Completion
2009-02-28
Completion
2009-02-28

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01400256 on ClinicalTrials.gov