Dementia Clinical Trial
— OPHELIE-COGOfficial title:
Influence of the Pre-existing Cognitive Status on the Outcome in Patients Treated by Thrombolytic Therapy for Acute Cerebral Ischaemia
At the acute stage of cerebral ischaemia, the only effective drug that increases the
proportion of patients who survive without dependency is thrombolytic therapy by intravenous
(i.v.) tissue-plasminogen activator (t-PA). This treatment is entered into routine practice
with similar results than in trials, in various places of the world including Europe and
Japan.
Stroke and dementia are closely related. About one patient in ten has dementia before a
first-ever stroke, and more than one in three has dementia after a recurrent stroke.
Pre-existing dementia is associated with a worse outcome of stroke, and pre-existing
cognitive impairment without dementia is associated with a higher rate of
institutionalisation within 3 years. In many patients cognitive impairment is due to the
summation of the effects of vascular and Alzheimer lesions of the brain.
More and more patients nowadays who are eligible for rt-PA are already known as demented at
admission. A retrospective study conducted in a cohort of patients with dementia who had an
ischaemic stroke and were treated by rtPA suggested that there is no increased risk of
cerebral bleeding and death as compared with non demented patients. However, pre-existing
cognitive impairment is possibly associated with (i) an increased risk of bleeding in
patients with cognitive impairment, and (ii) a higher sensitivity to the neurotoxic effect
of rt-PA on the brain tissue.
Japanese patients differ from European patients by a higher risk of spontaneous intracranial
haemorrhage, and a higher proportion of patients with small-vessel diseases.
The primary objective of the OPHELIE-COG study is to determine whether ischaemic stroke
patients who are treated with i.v. rt-PA are more likely to have a poor outcome (defined as
a modified Rankin scale 2 to 6 at month 3) in the presence of pre-existing cognitive
impairment or dementia. The secondary objectives are to determine whether (i) they have an
increased risk of symptomatic intracerebral haemorrhages, (ii) the proportion of patients
who have a poor outcome is lower than expected from the placebo group of randomised trials
for patients with a similar range of baseline severity, and (iii) the influence of the
cognitive state on outcome differs between Japanese and European patients.
Status | Completed |
Enrollment | 205 |
Est. completion date | March 2015 |
Est. primary completion date | December 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - All patients treated by iv tPA for cerebral ischaemia in routine practice in participating centres Exclusion Criteria: - index ischaemic stroke sparing MCA territory; - thrombolytic therapy administered intra-arterially or combined with thrombectomy - pre-stroke mRS of 2 or more - impossibility to perform an IQCODE for any reason (no reliable informant available within 48 hours, not fluent in French or in Japanese or in a language spoken by the investigator), except when the patient had been diagnosed as demented by a specialist used to diagnose dementia (e.g. neurologist, psychiatrist, geriatrician) before stroke, or has a MMSE score of 30 at discharge. |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
France | Lille University Hospital | Lille | |
Japan | Fukuoka Redcross Hospital | Fukuoka | |
Japan | Fukuoka-Higashi Medical center | Fukuoka | |
Japan | Kyushu Medical Center | Fukuoka | |
Japan | Kyushu University | Fukuoka | |
Japan | Kyushu Rosai Hospital | Kitakyushu | |
Japan | Steel Memorial Yawata Hospital | Kitakyushu | |
Japan | Kawasaki Medical University | Kurashiki | |
Japan | St. Mary's Hospital | Kurume |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Lille |
France, Japan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Modified Rankin Scale score 0 or 1 | Month-3 | No | |
Secondary | Symptomatic intracerebral haemorrhage defined according to the ECASS2 definition | 7 days | Yes | |
Secondary | Death | Day 7 | Yes | |
Secondary | Modified Rankin Scale 0-2 | Month-3 | No | |
Secondary | Death | Month-3 | No |
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