Acute Ischaemic Stroke MedDRA version: 9.1 Level: PT Classification code 10061256 Term: Ischaemic stroke
Conditions
Interventions
Product Name: V10153
Pharmaceutical Form: Injection*
CAS Number: 931101-84-7
Current Sponsor code: V10153
Other descriptive name: Recombinant thrombin-activatable plasminogen
Concentration unit: mg/ml
Sponsors
Vernalis (R & D) Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Onset of new neurological signs of a stroke within 3 to 9 hours of the time to initiation of treatment with V10153. 2. Be aged 18 and over. 3. Provide written informed consent or appropriate surrogate consent and agree to comply with all protocol-specific procedures. (After it has been determined that a patient meets all of the clinical and CT scan inclusion criteria and none of the exclusion criteria, and after the study has been explained to the patient or the patient’s legal representative, he/she will be asked to sign a consent form prior to angiography, (unless angiography is standard of care)). 4. Cerebral CT scan to show findings of early ischaemic changes consistent with the clinical diagnosis and an ASPECT score of between 5 and 10 inclusive. 5. Have a NIHSS score > 5 - at least 20. 6. Patients with angiographic complete occlusion (TIMI 0) or penetration with minimal perfusion (TIMI 1) in any part of the middle cerebral artery (MCA), with that occlusion being consistent with the patient’s clinical presentation, (see Section 6.2.3 for TIMI definitions). Patients with tandem occlusions (carotid occlusion at bifurcation with thrombus in MCA) may also be enrolled. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Central Nervous System 1. Coma. 2. Stroke with unknown time of onset (unless last known to be well within the 9 hour window). 3. Minor symptoms and signs ( 20 on the NIHSS). 5. Basilar artery territory strokes. 6. Suspected lacunar or white matter stroke. 7. Any history of stroke (haemorrhagic, embolic, thrombotic or transient ischaemic attack) within the previous 6 weeks. 8. Any prior neurological event which would obscure the interpretation of the signal neurological deficits. 9. Any history of brain tumours (small incidental meningioma are permitted). 10. CT scan results in an ASPECT score of 1.5. 2. If creatinine is known, exclude for serum creatinine > 2.5 times the upper limit of normal (ULN). 3. Haemoglobin 135kg. 3.Uncontrolled hypertension at study entry, non-responsive to acute intravenous therapy. Uncontrolled hypertension is defined as mean systolic blood pressure > 180 mm Hg or diastolic blood pressure > 110 mm Hg on three repeated measures at least 5 minutes apart. 4. Blood glucose > 12.0 mmol/L. 5. Known serious sensitivity to contrast agents, or any condition in which CT
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To establish the safety of five dose levels (1.0, 2.5, 5.0, 7.5 and 10.0 mg/kg) of V10153 in patients with acute ischaemic stroke.;Secondary Objective: To compare recanalisation rates across dose levels. To compare clinical outcome between treatments by National Institue of Health Stroke Survey (NIHSS) at 24 hours, 5, 30 and 90 days and Modfied Rankin Score and Barthel Index at 5, 30 and 90 days.;Primary end point(s): Primary Safety: Safety determined through clinical assessment (intercranial haemorrhage (ICH), major systemic bleed, other serious adverse events (SAEs)). Adverse Events. Laboratory Variables. Vital Signs. ECG. Primary Efficacy: Recanalisation rates from a blinded assessment of CT Angiograms at 0 and 2 hours will be compared between dose levels. Secondary Efficacy: Clinical Outcome according to NIHSS at 24 hours, 5, 30 and 90 days, Modified Rankin Scale and Barthel Index at 5 days, 30 days and 90 days after treatment. | — |
Countries
Czech Republic, Denmark, Hungary
Outcome results
None listed