Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000237886
Ethics application status
Approved
Date submitted
10/02/2012
Date registered
24/02/2012
Date last updated
3/10/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
PERTH IV MINOCYCLINE STROKE STUDY (PIMSS)
Scientific title
PERTH IV MINOCYCLINE STROKE STUDY (PIMSS)

A phase II, multicentre prospective randomised open-label blinded endpoint evaluation (PROBE) pilot study of IV minocycline, 200mg daily for 2 days, for patients with ischaemic or haemorrhagic stroke, commencing within 24hours of symptom onset, compared with routine stroke care.
Secondary ID [1] 280013 0
N/A
Universal Trial Number (UTN)
U1111-1128-0587
Trial acronym
PIMSS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ischaemic stroke 285689 0
Haemorrhagic stroke 285690 0
Condition category
Condition code
Stroke 285876 285876 0 0
Ischaemic
Stroke 285902 285902 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Following randomisation, patients will be treated with either:
Intravenous Minocycline 100mg at Baseline and then 12 hourly for a total of 5 dose; or routine stroke unit care.
Intervention code [1] 284130 0
Treatment: Drugs
Comparator / control treatment
Routine Stroke unit Care (Best Practice)
Control group
Active

Outcomes
Primary outcome [1] 286373 0
Good neurological outcome (modified Rankin score=0-2) at 3 months
Timepoint [1] 286373 0
At 3 months
Secondary outcome [1] 295709 0
Categorical shift in modified Rankin score at 3 months
Timepoint [1] 295709 0
At 3 months

Eligibility
Key inclusion criteria
1.Age 18 years or older
2.Onset of stroke < 24 hours.
3.Measurable neurological deficit on NHISS
4.Able to provide informed consent or
Next of Kin waver of consent for patients unable to provide voluntary consent due to stroke disability.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1.Evidence of other significant CNS disease that interferes with assessment (eg tumor, multiple sclerosis)
2.Known allergy to tetracyclines/intolerance of minocycline.
3.Known systemic lupus erythrematosis.
4.Idiopathic intracranial hypertension.
5.Concurrent treatment with Vitamin A or retinoids.
6.Participation in another clinical drug trial.
7.Known significant renal failure; CLcr < 30 mL/min by the Crockoft-Gault equation.
8.Known significantly abnormal liver function tests (ALT > x3 ULN)
9.Thrombocytopaenia < 100
10.Concurrent infection (at enrolment) requiring antibiotic treatment.
11.Pregnancy.
12.Severe stroke or other co-morbidities likely to result in the patient dying within a week.
NB – thrombolytic therapy is NOT an exclusion criterion.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients will be drawn from those referred to the Stroke Units at the involved centers. Screening evaluation for suitability includes baseline history, physical examination, NIHSS, CT or MRI brain, blood tests and assessement of inclusion/exclusion criteria. After obtaining informed consent the admitting neurology doctor will use a randomisation table generated by pharmacy.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients will be drawn from those referred to the Stroke Units at the involved centers. Screening evaluation for suitability includes baseline history, physical examination, NIHSS, CT or MRI brain, blood tests and assessement of inclusion/exclusion criteria. After obtaining informed consent the admitting neurology doctor will use a randomisation table generated by pharmacy. The research assistant will be notified of treatment allocation. A blinded assessor will perform NIHSS and record vital signs on day 1,2 and 7.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/02/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284583 0
Government body
Name [1] 284583 0
National Health and Medical research council (NHMRC)
Country [1] 284583 0
Australia
Funding source category [2] 284677 0
Self funded/Unfunded
Name [2] 284677 0
Clin A/Prof David Blacker
Country [2] 284677 0
Australia
Primary sponsor type
Hospital
Name
Sir Charles Gairdner Hospital
Address
Sir Charles Gairdner Hospital
Hospital Avenue NEDLANDS
Perth, WA 6009
Country
Australia
Secondary sponsor category [1] 283501 0
Hospital
Name [1] 283501 0
Royal Perth Hospital
Address [1] 283501 0
Royal Perth Hospital
Wellington Street
Perth, WA,6000
Country [1] 283501 0
Australia
Secondary sponsor category [2] 283581 0
Hospital
Name [2] 283581 0
Swan Districts Hospital
Address [2] 283581 0
Swan Districts Hospital
Eveline Rd
Middle Swan, WA, 6056
Country [2] 283581 0
Australia
Other collaborator category [1] 260532 0
Individual
Name [1] 260532 0
Dr David Blacker
Address [1] 260532 0
Dept of Neurology
Sir Charles Gairdner Hospital
Nedlands WA 6009
Country [1] 260532 0
Australia
Other collaborator category [2] 260533 0
Individual
Name [2] 260533 0
Dr David Prentice
Address [2] 260533 0
Department of Internal medicine
Royal Perth Hospital
Wellington Street
Perth 6000
Country [2] 260533 0
Australia
Other collaborator category [3] 260534 0
Individual
Name [3] 260534 0
Professor Graeme Hankey
Address [3] 260534 0
Stroke Unit
Royal Perth Hospital
Wellington Street
PERTH 6000
Country [3] 260534 0
Australia
Other collaborator category [4] 260535 0
Individual
Name [4] 260535 0
Dr Edith Kohler
Address [4] 260535 0
Royal Perth Hospital
Wellington Street
PERTH 6000
Country [4] 260535 0
Australia
Other collaborator category [5] 260536 0
Individual
Name [5] 260536 0
Dr Timothy Bates
Address [5] 260536 0
Stroke Unit
Swan Districts Hospital
Eveline Rd
Middle Swan, WA, 6056
Country [5] 260536 0
Australia
Other collaborator category [6] 277111 0
Individual
Name [6] 277111 0
Anne Claxton
Address [6] 277111 0
Stroke Unit Royal Perth Hospital Wellington Street PERTH 6000
Country [6] 277111 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286570 0
HREC Royal Perth Hospital
Ethics committee address [1] 286570 0
HREC Royal perth Hospital
level 5, Colonial House
Royal Perth Hospital
Wellington Street
perth WA 6000
Ethics committee country [1] 286570 0
Australia
Date submitted for ethics approval [1] 286570 0
Approval date [1] 286570 0
18/12/2009
Ethics approval number [1] 286570 0
2009/121
Ethics committee name [2] 286690 0
HREC Sir Charles Gairdner Hospital
Ethics committee address [2] 286690 0
The Human Research Ethics Commitee
Level 2, A-Block
Sir Charles Gairdner Hospital
Hospital Avenure Nedlands WA 6009
Ethics committee country [2] 286690 0
Australia
Date submitted for ethics approval [2] 286690 0
Approval date [2] 286690 0
16/09/2010
Ethics approval number [2] 286690 0
2010/004
Ethics committee name [3] 286692 0
HREC Swan Districts Hospital
Ethics committee address [3] 286692 0
Ethics committee country [3] 286692 0
Australia
Date submitted for ethics approval [3] 286692 0
Approval date [3] 286692 0
Ethics approval number [3] 286692 0

Summary
Brief summary
To test the hypothesis that acute stroke patients (both ischaemic and haemorrhagic) treated with IV minocycline within 24 hours of symptom onset have improved clinical outcomes compared with standard stroke care.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33690 0
Address 33690 0
Country 33690 0
Phone 33690 0
Fax 33690 0
Email 33690 0
Contact person for public queries
Name 16937 0
Anne Claxton
Address 16937 0
Stroke Unit Research
Level 8, A Block
Royal Perth Hospital
Wellington Street
Perth. WA. 6000
Country 16937 0
Australia
Phone 16937 0
+61 8 9224 3461
Fax 16937 0
Email 16937 0
anne.claxton@health.wa.gov.au
Contact person for scientific queries
Name 7865 0
Dr Edith Kohler
Address 7865 0
Royal Perth Hospital
Wellington street
Perth, WA, 6000
Country 7865 0
Australia
Phone 7865 0
+61 8 9224 2244
Fax 7865 0
Email 7865 0
Edith_Kohler@hotmail.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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