Safety and Efficacy Study in Acute Ischaemic Stroke

A Phase II, Multi-centre, Two-part Study to Evaluate the Safety and Efficacy of Study Drug in Acute Ischaemic Stroke.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00144014

Acronym

VASST

Enrollment

Registered

2005-09-02

Start date

2005-08-31

Completion date

2009-03-31

Last updated

2016-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

Acute, Ischaemic, Stroke

Brief summary

A Phase II study to evaluate the safety and efficacy of five dose levels of study drug in acute ischaemic stroke

Detailed description

An open label, dose escalation study where patients with acute ischaemic stroke will receive a single intravenous dose of study drug. There will be five dose levels with groups of 10 patients in each. Escalation to higher doses will occur following review of safety data from the previous dose.

Interventions

DRUGV10153

Single acute intravenous bolus dose up to 10 mg/kg

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Summary of Inclusion Criteria: 1. Onset of new neurological signs of stroke within 3 to 9 hours of the time to initiation of treatment 2. Aged 18 and above 3. Provide consent 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. NIHSS score greater than 5 or less than or equal to 20. Summary of

Exclusion criteria

1. Coma 2. Stroke with unknown time of onset 3. Minor stroke symptoms and sings (\<6 points on the NIHSS) which are rapidly improving by the time of randomisation. 4. Major stroke symptoms and signs (\>20 on the NIHSS) 5. History of stroke in previous 6 weeks 6. History of brain tumours 7. CT scan results in an ASPECT score of \<5 8. Haemorrhagic risk 9. Abnormal laboratory values 10. Positive urine pregnancy test, lactation or parturition within previous 30 days. 11. Weight \>135 kg 12. Uncontrolled hypertension. 13. Raised blood glucose 14. History of or current serious illness 15. Participation in another clinical trial within 4 weeks of drug administration \-

Design outcomes

Primary

Measure	Time frame
To establish the safety of five dose levels (1.0, 2.5, 5, 7.5 and 10 mg/kg)of V10153 in patients with acute ischaemic stroke.	Ongoing

Secondary

Measure	Time frame
To compare recanalisation rates across dose levels.	Ongoing
To compare clinical outcome between treatments by NIHSS, Modified Rankin Scale and Barthel Index.	Post-study completion

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026