A Phase IIa, Multi-Centre Study to Evaluate the Safety and Efficacy of V10153 in Acute Ischaemic Stroke - VASTT

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 80

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

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 (< 6 points on the NIHSS) which are rapidly improving by the time of enrolment.
4. Major stroke 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 < 5, severe hypodensity lesion, haemorrhage of any degree, evidence of significant mass effect with midline shift due to large infarct, or subarachnoid haemorrhage.
11. CT angiogram shows no visible arterial occlusion in any part of the MCA.
12. Patients with van Sweiten Grade 4 (severe white matter disease).

Haemorrhagic Risk
1. Clinical presentation suggestive of subarachnoid haemorrhage, even if the initial CT scan is normal.
2. Previous known intracranial haemorrhage at any time, and/or subarachnoid haemorrhage. Patients with a known arteriovenous malformation or aneurysm with any evidence of associated haemorrhage.
3. Any recent invasive procedure (e.g. puncture of a non-compressible vessel (artery or vein) within 7 days of drug administration; surgery including ophthalmologic surgery, biopsy of a parenchymal organ, or lumbar puncture within 30 days of drug administration).
4. Trauma, including head trauma, with internal injuries or ulcerative wounds within 90 days of drug administration.
5. Active peptic ulcer disease within the 3 months prior to drug administration.
6. Any clinically significant active or recent haemorrhage within 30 days of drug administration.
7. Known hereditary or acquired haemorrhagic diathesis, e.g. activated Partial Thromboplastin Time (aPTT) greater than 1.5 times normal.
8. Treatment with heparin within 12 hours prior to drug administration other than a small amount for flushing intravenous cannulae.
9. Treatment with warfarin (unless the International Normalised Ratio (INR) is 1.5 or less) within 5 days prior to drug administration.
10. Treatment with low molecular weight heparin within 5 days prior to study drug administration.
11. Treatment with antiplatelet agents (dipyridamole, Aggrenox, ticlopidine) within 6 days prior to study drug administration with the exception of either aspirin (325 mgs or less daily) or clopidogrel (75 mgs, or less, daily) which are allowed, (but not both).

Laboratory
1. Baseline laboratory values which reveal platelets < 100,000/mm3, Haematocrit (Hct) or Packed Cell Volume (PCV) < 25 % or INR > 1.5.
2. If creatinine is known, exclude for serum creatinine > 2.5 times the upper limit of normal (ULN).
3. Haemoglobin < 10 g/dL = 100 g/L.
4. Haematocrit (Hct) or PCV < 25 %.

General
1. Positive urine pregnancy test, breast feeding or parturition within the previous 30 days.
2. Weight >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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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