Outcome of Patients Treated by iv Rt-PA for Cerebral Ischaemia According to the Ratio Sc-tPA/Tc-tPA (OPHELIE)
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|ClinicalTrials.gov Identifier: NCT01614080|
Recruitment Status : Completed
First Posted : June 7, 2012
Last Update Posted : December 19, 2014
|Condition or disease|
|Stroke, Acute Drug Toxicity|
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.
|Study Type :||Observational|
|Actual Enrollment :||700 participants|
|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|
|Study Start Date :||November 2011|
|Actual Primary Completion Date :||November 2014|
|Actual Study Completion Date :||December 2014|
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 [ Time Frame: Month 3 ]The proportion of the patients with modified Rankin Scale 0-1
- OPHELIE [ Time Frame: 7 days ]The proportion of the patients with symptomatic intra cerebral haemorrhage according to ECASS 2 definition
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|