Outcome of Patients Treated by iv Rt-PA for Cerebral Ischaemia According to the Ratio Sc-tPA/Tc-tPA (OPHELIE)
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).
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Outcome of Patients Treated by iv Rt-PA for Cerebral Ischaemia According to the Ratio Sc-tPA/Tc-tPA in the Administered Rt-PA|
- OPHELIE [ Time Frame: Month 3 ] [ Designated as safety issue: No ]The proportion of the patients with modified Rankin Scale 0-1
- OPHELIE [ Time Frame: 7 days ] [ Designated as safety issue: No ]The proportion of the patients with symptomatic intra cerebral haemorrhage according to ECASS 2 definition
|Study Start Date:||November 2011|
|Study Completion Date:||December 2014|
|Primary Completion Date:||November 2014 (Final data collection date for primary outcome measure)|
High sc-tPA/tc-tPA ratio group
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
Low sc-tPA/tc-tPA ratio
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 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01614080
|Lille University Hospital|
|Lille, France, 59037|
|Study Director:||Kei MURAO, MD||University Lille 2|
|Study Chair:||Denis VIVIEN, PhD||Institut National de la Santé Et de la Recherche Médicale, France|
|Principal Investigator:||Didier LEYS, MD, PhD||Lille University Hospital|