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Outcome of Patients Treated by iv Rt-PA for Cerebral Ischaemia According to the Ratio Sc-tPA/Tc-tPA

NCT ID: NCT01614080

Last Updated: 2014-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

700 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-11-30

Study Completion Date

2014-12-31

Brief Summary

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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

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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.

Conditions

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Stroke, Acute Drug Toxicity

Keywords

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Stroke Ischemic stroke thrombolysis toxicity of t-PA

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

No interventions assigned to this group

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role collaborator

University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kei MURAO, MD

Role: STUDY_DIRECTOR

University Lille 2

Denis VIVIEN, PhD

Role: STUDY_CHAIR

Institut National de la Santé Et de la Recherche Médicale, France

Didier LEYS, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Lille University Hospital

Locations

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Lille University Hospital

Lille, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 32015090 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27815401 (View on PubMed)

Other Identifiers

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2010_04

Identifier Type: OTHER

Identifier Source: secondary_id

10.677

Identifier Type: -

Identifier Source: org_study_id