Safety and Efficacy Study in Acute Ischaemic Stroke (VASST)

This study has been completed.

Sponsor:

Information provided by:

Vernalis (R&D) Ltd

ClinicalTrials.gov Identifier:

NCT00144014

First received: September 1, 2005

Last updated: March 19, 2009

Last verified: March 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

September 1, 2005

Last Updated Date

March 19, 2009

Start Date ^ICMJE

August 2005

Primary Completion Date

November 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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. [ Time Frame: Ongoing ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Safety will be determined through clinical assessment (intracranial haemorrhage (ICH), major systemic bleeding, other serious adverse events).

Change History

Complete list of historical versions of study NCT00144014 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To compare recanalisation rates across dose levels. [ Time Frame: Ongoing ] [ Designated as safety issue: No ]
To compare clinical outcome between treatments by NIHSS, Modified Rankin Scale and Barthel Index. [ Time Frame: Post-study completion ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Recanalisaiton reates from CT angiograms will be compared across doses.
Clinical outcome according to NIHSS, modified Rankin Scale and Barthel Index.
Safety will be determined by CT scan for evidence of ICH, adverse events, laboratory variables, vital signs, ECG

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Safety and Efficacy Study in Acute Ischaemic Stroke

Official Title ^ICMJE

A Phase II, Multi-Centre, Two-Part Study to Evaluate the Safety and Efficacy of Study Drug in 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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Stroke

Intervention ^ICMJE

Drug: V10153

Single acute intravenous bolus dose up to 10 mg/kg

Other Names:

Code Names: V10153, BB-10153
CAS Registry Number: 931101-84-7
Proposed INN: Troplasminogen alfa

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

March 2009

Primary Completion Date

November 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Summary of Inclusion Criteria:

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

Summary of Exclusion Criteria:

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

-

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Canada

Administrative Information

NCT Number ^ICMJE

NCT00144014

Other Study ID Numbers ^ICMJE

V10153-2S-01

Has Data Monitoring Committee

Yes

Responsible Party

Michael Hill, MD, Foothills Hospital

Study Sponsor ^ICMJE

Vernalis (R&D) Ltd

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Michael Hill

Foothills Hosptial

Information Provided By

Vernalis (R&D) Ltd

Verification Date

March 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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