Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01614080
Other study ID # 10.677
Secondary ID 2010_04
Status Completed
Phase N/A
First received April 23, 2012
Last updated December 18, 2014
Start date November 2011
Est. completion date December 2014

Study information

Verified date December 2014
Source University Hospital, Lille
Contact n/a
Is FDA regulated No
Health authority France: The Commission nationale de l’informatique et des libertés
Study type Observational

Clinical Trial Summary

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).


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 700
Est. completion date December 2014
Est. primary completion date November 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Being treated by iv tPA for acute cerebral ischaemia

Exclusion Criteria:

- absence of reliable informant

- no rtPA left in the syringe after treatment

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
France Lille University Hospital Lille

Sponsors (2)

Lead Sponsor Collaborator
University Hospital, Lille Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary OPHELIE The proportion of the patients with modified Rankin Scale 0-1 Month 3 No
Secondary OPHELIE The proportion of the patients with symptomatic intra cerebral haemorrhage according to ECASS 2 definition 7 days No
See also
  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
Not yet recruiting NCT05534360 - Tenecteplase Treatment in Ischemic Stroke Registry
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 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