Clinical trial NCT01614080: Outcome of Patients Treated by iv Rt-PA for Cerebral Ischaemia According to the Ratio Sc-tPA/Tc-tPA
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke, Acute
Drug Toxicity
Keywords: Stroke
Ischemic stroke
thrombolysis
toxicity of t-PA
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2012-06-07
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients treated in routine by iv t-PA for acute ischaemic stroke

Brief 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).

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: OPHELIE
timeFrame: Month 3
Secondary outcomes:
measure: OPHELIE
timeFrame: 7 days
Other outcomes:
Locations:
city: Lille
country: France
facility: Lille University Hospital
Study officials:
affiliation: University Lille 2
name: Kei MURAO, MD
role: STUDY_DIRECTOR
affiliation: Institut National de la Santé Et de la Recherche Médicale, France
name: Denis VIVIEN, PhD
role: STUDY_CHAIR
affiliation: Lille University Hospital
name: Didier LEYS, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Caparros F, Kuchcinski G, Drelon A, Casolla B, Moulin S, Dequatre-Ponchelle N, Henon H, Cordonnier C, Pruvo JP, Leys D. Use of MRI to predict symptomatic haemorrhagic transformation after thrombolysis for cerebral ischaemia. J Neurol Neurosurg Psychiatry. 2020 Apr;91(4):402-410. doi: 10.1136/jnnp-2019-321904. Epub 2020 Feb 3.
citation: Leys D, Hommet Y, Jacquet C, Moulin S, Sibon I, Mas JL, Moulin T, Giroud M, Sagnier S, Cordonnier C, Medeiros de Bustos E, Turc G, Ronziere T, Bejot Y, Detante O, Ouk T, Mendyk AM, Favrole P, Zuber M, Triquenot-Bagan A, Ozkul-Wermester O, Montoro FM, Lamy C, Faivre A, Lebouvier L, Potey C, Poli M, Henon H, Renou P, Dequatre-Ponchelle N, Bodenant M, Debruxelles S, Rossi C, Bordet R, Vivien D; OPHELIE investigators and the STROKAVENIR network. Proportion of single-chain recombinant tissue plasminogen activator and outcome after stroke. Neurology. 2016 Dec 6;87(23):2416-2426. doi: 10.1212/WNL.0000000000003399. Epub 2016 Nov 4.