An observational study in Stroke, Acute and Drug Toxicity, sponsored by University Hospital, Lille. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-12-19.
Sponsored by University Hospital, Lille · Observational
intravenous rt-PA is effective to reduce the risk of death or dependency after ischaemic stroke. This effect is due to an early recanalization secondary to the lysis of the clot. However this effect may be counterbalanced by the increased risk of bleeding and also the neurotoxicity of rt-PA, which has been shown in animals to depend on the ratio single chain (sc) / double chain (tc) in the rt-PA administered. The main objective of OPHELIE is to determine whether the functional outcome after treatment by iv rt-PA depends on the ratio sc-rtPA / tc-rtPA. Secondary objectives were to identify the influence on the risk of brain haemorrhage, and the influence of the cognitive state (OPHELIE-COG substudy).
OPHELIE is a multicenter study conducted in France in 25 centers where patients treated by iv rt-PA will be included. Patients are treated according to the local protocol, without any modification specifically for this study. A sample of 2 drops of the rt-PA used for the treatment is stored for analysis, to determine the sc-tPA/tc-tPA ration (immunostaining).
700 patients are needed for the study assuming that a difference of 5% will be found in the primary outcome measure (modified Rankin scale 0-1 at 3 months) with alpha and beta risks respectively of 5% and 20%.
The participating clinical centres recruit altogether more than 500 patients per year for thrombolysis. Assuming that 70% will be eligible, the recruitment should take less than 2 years.
7,286 studies on the registry are indexed under Stroke; 2,013 are open to participants now.
This study's enrollment of 700 is above the median of 160 across 1,692 observational studies indexed under Stroke.
Browse Stroke studies →University Hospital, Lille is the lead sponsor of 625 studies on the registry; 141 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients treated in routine by iv t-PA for acute ischaemic stroke
Exclusion Criteria:
A threshold value of the sc-tPA/tc-tPA ratio will be defined as the median value found in the population. The High sc-tPA/tc-tPA ratio group will be defined as the group of patients with a sc-tPA/tc-tPA ratio higher than the median
A threshold value of the sc-tPA/tc-tPA ratio will be defined as the median value found in the population. The Low sc-tPA/tc-tPA ratio group will be defined as the group of patients with a sc-tPA/tc-tPA ratio lower than the median
OPHELIE
The proportion of the patients with modified Rankin Scale 0-1
Time frame: Month 3
OPHELIE
The proportion of the patients with symptomatic intra cerebral haemorrhage according to ECASS 2 definition
Time frame: 7 days
This study is completed, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.
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University Hospital, Lille