Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

July 25, 2007
July 25, 2007
March 2005
Not Provided
Incidence of symptomatic intracranial hemorrhage [ Time Frame: 72 hours ]
Same as current
No Changes Posted
  • 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 ]
Same as current
Not Provided
Not Provided
 
Microbubble-Enhanced Clotbust Treatment of Acute Ischemic Stroke
Microbubble-Enhanced Clotbust Treatment of Acute Ischemic Stroke

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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Acute Ischemic Stroke
Drug: perflutren lipid microsphere
Other Name: Definity
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
Not Provided
May 2006
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00507806
MRX-815-401
Yes
Not Provided
ImaRx Therapeutics
Not Provided
Principal Investigator: Andrei Alexandrov, MD The University of Texas Health Science Center, Houston
ImaRx Therapeutics
July 2007

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