Stroke, Acute Clinical Trial
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
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.
;
Observational Model: Cohort, Time Perspective: Prospective
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05378035 -
DOAC in Chinese Patients With Atrial Fibrillation
|
||
| Completed |
NCT03679637 -
Tablet-based Aphasia Therapy in the Acute Phase After Stroke
|
N/A | |
| Completed |
NCT03574038 -
Transcranial Direct Current Stimulation as a Neuroprotection in Acute Stroke
|
N/A | |
| Completed |
NCT03633422 -
Evaluation of Stroke Patient Screening
|
||
| Completed |
NCT04088578 -
VNS-supplemented Motor Retraining After Stroke
|
N/A | |
| Withdrawn |
NCT04991038 -
Clinical Investigation to Compare Safety and Efficacy of DAISE and Stent Retrievers for Thrombectomy In Acute Ischemic Stroke Patients
|
N/A | |
| Not yet recruiting |
NCT05534360 -
Tenecteplase Treatment in Ischemic Stroke Registry
|
||
| Not yet recruiting |
NCT04105322 -
Effects of Kinesio Taping on Balance and Functional Performance in Stroke Patients
|
N/A | |
| Withdrawn |
NCT05786170 -
ERILs Und SNILs Unter SOC
|
N/A | |
| Recruiting |
NCT03132558 -
Contrast Induced Acute Kidney in Patients With Acute Stroke
|
N/A | |
| Completed |
NCT02893631 -
Assessment of Hemostasis Disorders in rtPA-treated Patients Requiring Endovascular Treatment for Ischemic Stroke
|
||
| Active, not recruiting |
NCT02274727 -
Biomarker Signature of Stroke Aetiology Study: The BIOSIGNAL-Study
|
||
| Completed |
NCT02225730 -
Imaging Collaterals in Acute Stroke (iCAS)
|
||
| Terminated |
NCT01705353 -
The Role of HMGB-1 in Chronic Stroke
|
N/A | |
| Active, not recruiting |
NCT01581502 -
SAMURAI-NVAF Study: Anticoagulant Therapy for Japanese Stroke Patients With Nonvalvular Atrial Fibrillation (NVAF)
|
N/A | |
| Completed |
NCT01182818 -
Fabry and Stroke Epidemiological Protocol (FASEP): Risk Factors In Ischemic Stroke Patients With Fabry Disease
|
N/A | |
| Completed |
NCT00761982 -
Autologous Bone Marrow Stem Cells in Middle Cerebral Artery Acute Stroke Treatment.
|
Phase 1/Phase 2 | |
| Completed |
NCT00535197 -
Autologous Bone Marrow Stem Cells in Ischemic Stroke.
|
Phase 1/Phase 2 | |
| Terminated |
NCT00132509 -
FRALYSE Trial: Comparison of the Classical Rt-PA Procedure With a Longer Procedure in Acute Ischemic Stroke
|
Phase 2 | |
| Recruiting |
NCT05760326 -
Diagnostic and Prognostic Role of Clot Analysis in Stroke Patients
|