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Microbubble-Enhanced Clotbust Treatment of Acute Ischemic Stroke

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ClinicalTrials.gov Identifier: NCT00507806
Recruitment Status : Terminated (for administrative reasons)
First Posted : July 27, 2007
Last Update Posted : July 27, 2007
Sponsor:
Information provided by:
ImaRx Therapeutics

Tracking Information
First Submitted Date  ICMJE July 25, 2007
First Posted Date  ICMJE July 27, 2007
Last Update Posted Date July 27, 2007
Study Start Date  ICMJE March 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: July 25, 2007)
Incidence of symptomatic intracranial hemorrhage [ Time Frame: 72 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 25, 2007)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Microbubble-Enhanced Clotbust Treatment of Acute Ischemic Stroke
Official Title  ICMJE Microbubble-Enhanced Clotbust Treatment of Acute Ischemic Stroke
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acute Ischemic Stroke
Intervention  ICMJE Drug: perflutren lipid microsphere
Other Name: Definity
Study Arms  ICMJE Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE May 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00507806
Other Study ID Numbers  ICMJE MRX-815-401
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE ImaRx Therapeutics
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Andrei Alexandrov, MD The University of Texas Health Science Center, Houston
PRS Account ImaRx Therapeutics
Verification Date July 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP