None listed
Conditions
Brief summary
The main AFFINITY trial is investigating whether fluoxetine, 20mg once daily, started 2 -15 days after stroke onset and continued for 6 months, improves functional outcome at 6 months after randomisation. The aims of the sub study (AFFINITY BM) are to further investigate the underlying biological, structural and functional mechanisms by which treatment with fluoxetine may lead to improved functional outcomes following acute stroke.
Interventions
1. Fluoxetine or placebo (double-blind) as the study drug under investigation in the main AFFINITY trial (ACTRN: 12611000774921)
2. Blood sample for biochemical and DNA analysis to be collected at Baseline/Randomisation if possible; and if not at any of the other main AFFINITY trial follow up assessment points [Day 28, Day 90, Day 180, Day 365 Visits]
3. MRI brain scan at Baseline/Randomisation and at the Day 180 Follow Up Assessment Visit for the main AFFINITY Trial.
4. All Main trial follo
1. Fluoxetine or placebo (double-blind) as the study drug under investigation in the main AFFINITY trial (ACTRN: 12611000774921) 2. Blood sample for biochemical and DNA analysis to be collected at Baseline/Randomisation if possible; and if not at any of the other main AFFINITY trial follow up assessment points [Day 28, Day 90, Day 180, Day 365 Visits] 3. MRI brain scan at Baseline/Randomisation and at the Day 180 Follow Up Assessment Visit for the main AFFINITY Trial. 4. All Main trial follow up continues as per protocol.
Sponsors
Sir Charles Gairdner Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Participants may partake of either one or both of the sub studies Inclusion criteria: Blood Biomarkers sub study: Participants randomised and participating in the AFFINITY Trial Inclusion criteria: MRI neuroimaging sub study: Participants randomised and participating in the AFFINITY Trial Brain imaging consistent with an ischaemic stroke of either hemisphere Brain imaging conducted within 21 days of qualifying stroke event
Exclusion criteria
Exclusion criteria: MRI neuroimaging sub study: Brain imaging consistent with haemorrhagic (intracerebral and / or subarachnoid) stroke Contra-indication to having a MRI e.g. implanted pacemaker or severe claustrophobia (these people can still participate in the blood biomarker sub-study) Unable to undergo follow up MRI at six months
Outcome results
None listed