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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
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