Blood Pressure Lowering in Acute Stroke Trial (BLAST)
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|ClinicalTrials.gov Identifier: NCT01400256|
Recruitment Status : Withdrawn (lack of recruitment/patient population)
First Posted : July 22, 2011
Last Update Posted : May 9, 2016
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|Condition or disease||Intervention/treatment||Phase|
|Stroke, Acute||Drug: Valsartan||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||The Use of Valsartan for the Management of Blood Pressure in Acute Stroke: Affects on Cerebral Blood Flow|
|Study Start Date :||August 2007|
|Actual Primary Completion Date :||February 2009|
|Actual Study Completion Date :||February 2009|
- 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.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT01400256
|United States, California|
|Stanford University Medical Center|
|Stanford, California, United States, 94304|
|Principal Investigator:||Gregory Albers, M.D||Stanford University|
|Principal Investigator:||Neil Schwartz, M.D||Stanford University|
|Responsible Party:||Neil Schwartz, Principle Investigator, Stanford University|
|Other Study ID Numbers:||
|First Posted:||July 22, 2011 Key Record Dates|
|Last Update Posted:||May 9, 2016|
|Last Verified:||May 2016|
Central Nervous System Diseases
Nervous System Diseases
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action