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Clinical Trials/CTRI/2015/02/005556
CTRI/2015/02/005556
Completed
Phase 3

Clinical trial to assess the efficacy and safety of TNK-TPA in Acute Ischemic Stroke - TNK-TPA

Gennova Biopharmaceuticals Ltd0 sites62 target enrollmentTBD

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Not specified
Sponsor
Gennova Biopharmaceuticals Ltd
Enrollment
62
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
October 28, 2016
Last Updated
3 years ago
Study Type
Interventional

Investigators

Eligibility Criteria

Inclusion Criteria

  • 1\.Acute ischemic stroke with serious measurable deficit on National Institute of Health Stroke Scale (NIHSS)
  • 2\.Treatment within 3 hours of stroke onset
  • 3\.Age 18 to 75 years
  • 4\.Patient or legally acceptable representative willing to give informed written consent before study procedure

Exclusion Criteria

  • 1\.Minor stroke symptoms, or major symptoms rapidly improving
  • 2\.Intracranial hemorrhage on pretreatment head computerised tomography (CT) scan
  • 3\.Clinical presentation suggesting subarachnoid haemorrhage
  • 4\.Pregnancy
  • 5\.Known bleeding diathesis and/or platelet count \< 100000 mm3
  • 6\.Patient taking oral anticoagulants
  • 7\.Patients who have received heparin within 48 hours
  • 8\.Major surgery or serious trauma within 14 days; serious head trauma within 3 months
  • 9\.Gastrointestinal or urinary tract hemorrhage within 21 days
  • 10\.Arterial puncture at a noncompressible site or lumbar puncture within 7 days

Outcomes

Primary Outcomes

Not specified

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