Microbubble-Enhanced Clotbust Treatment of Acute Ischemic Stroke

This study has been terminated.

(for administrative reasons)

Sponsor:

Information provided by:

ImaRx Therapeutics

ClinicalTrials.gov Identifier:

NCT00507806

First received: July 25, 2007

Last updated: NA

Last verified: July 2007

History: No changes posted

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 1 Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Microbubble-Enhanced Clotbust Treatment of Acute Ischemic Stroke

Resource links provided by NLM:

Drug Information available for: Perflutren

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

Intervention Details:

Other Name: Definity

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, Moyé 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.


ClinicalTrials.gov Identifier:	NCT00507806 History of Changes
Other Study ID Numbers:	MRX-815-401
Study First Received:	July 25, 2007
Last Updated:	July 25, 2007
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:


Stroke Ischemia Cerebral Infarction Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases	Nervous System Diseases Vascular Diseases Cardiovascular Diseases Pathologic Processes Brain Infarction Brain Ischemia

ClinicalTrials.gov processed this record on September 26, 2016

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