CTRI/2015/02/005556CompletedPhase 3
Clinical trial to assess the efficacy and safety of TNK-TPA in Acute Ischemic Stroke - TNK-TPA
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 62
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
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
- •11.Uncontrolled baseline hypertension ( >185/110 mm Hg)
- •12.Clinical stroke within 3 months or history of intracranial hemorrhage
- •13.Myocardial infraction in past 30 days
- •14.Other serious medical illness likely to interfere with treatment or treatment might adversely affect that illness
- •15.Seizure at stroke onset
- •16.Confounding pre-existent neurological or psychiatric disease
- •17.Any other investigational drug within 14 days
- •18.Large areas (greater than one lobe) of obvious low density on baseline head CT scan
- •19.Unlikely to complete the protocol follow-up
- •20.Any condition that, in the opinion of the investigator, does not justify the patientsââ?¬• inclusion in the study.
Investigators
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