Microbubble-Enhanced Clotbust Treatment of Acute Ischemic Stroke

This study has been terminated.

( for administrative reasons )

First Received: July 25, 2007 No Changes Posted

Sponsor:	ImaRx Therapeutics
Information provided by:	ImaRx Therapeutics
ClinicalTrials.gov Identifier:	NCT00507806

Purpose

The study is designed to examine the safety, tolerability, and activity of a combination of microbubbles (perflutren lipid microsphere [Definity®]) and continuous monitoring with 2 MHz transcranial Doppler ultrasound (TCD) as an adjunctive therapy to tissue plasminogen activator (tPA) treatment in subjects with acute ischemic stroke.

Condition	Intervention	Phase
Acute Ischemic Stroke	Drug: perflutren lipid microsphere	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Microbubble-Enhanced Clotbust Treatment of Acute Ischemic Stroke

Resource links provided by NLM:

Drug Information available for: Octafluoropropane

U.S. FDA Resources

Further study details as provided by ImaRx Therapeutics:

Primary Outcome Measures:

Incidence of symptomatic intracranial hemorrhage [ Time Frame: 72 hours ]

Secondary Outcome Measures:

Complete recanalization of the occluded artery (TIBI 4-5) [ Time Frame: End of treatment ]
NIHSS score of 0-2 [ Time Frame: 24 hours ]
Favorable outcome (modified Rankin Scale or NIHSS 0-1) [ Time Frame: 3 months ]

Study Start Date:	March 2005
Study Completion Date:	May 2006

Eligibility

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

Criteria

Inclusion Criteria:

Measurable focal neurological deficit (National Institutes of Health Stroke Scale [NIHSS] score > 4 points)
tPA eligible
Occlusion of the middle cerebral artery

Exclusion Criteria:

Right to left cardiac shunt
Uncontrolled hypertension
Absent temporal windows

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00507806

Sponsors and Collaborators

ImaRx Therapeutics

Investigators

Principal Investigator:

Andrei Alexandrov, MD

The University of Texas Health Science Center, Houston

More Information

Publications:

Alexandrov AV, Molina CA, Grotta JC, Garami Z, Ford SR, Alvarez-Sabin J, Montaner J, Saqqur M, Demchuk AM, Moye LA, Hill MD, Wojner AW; CLOTBUST Investigators. Ultrasound-enhanced systemic thrombolysis for acute ischemic stroke. N Engl J Med. 2004 Nov 18;351(21):2170-8.

Study ID Numbers:	MRX-815-401
Study First Received:	July 25, 2007
Last Updated:	July 25, 2007
ClinicalTrials.gov Identifier:	NCT00507806 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by ImaRx Therapeutics:

Acute Ischemic Stroke
Microbubbles
Transcranial Doppler ultrasound
TIBI

Symptomatic Intracranial Hemorrhage
modified Rankin Scale
Recanalization
Perflutren

Additional relevant MeSH terms:

Pathologic Processes
Cerebral Infarction
Nervous System Diseases
Stroke
Vascular Diseases
Brain Ischemia

Central Nervous System Diseases
Cardiovascular Diseases
Brain Infarction
Ischemia
Brain Diseases
Cerebrovascular Disorders

ClinicalTrials.gov processed this record on November 20, 2009