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

Completed

• Conditions: Drug Toxicity; Stroke, Acute

• Registration Number: NCT01614080
• Lead Sponsor: University Hospital, Lille

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.

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2012-04-23
• Study First Submitted QC: 2012-06-04
• Study First Posted: 2012-06-07
• Primary Completion: 2014-11
• Status Verified: 2014-12
• Study Completion: 2014-12
• Last Update Submitted: 2014-12-18
• Last Update Posted: 2014-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 700

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
OPHELIE	Month 3	The proportion of the patients with modified Rankin Scale 0-1

Secondary Outcome Measures

Name	Time	Method
OPHELIE	7 days	The proportion of the patients with symptomatic intra cerebral haemorrhage according to ECASS 2 definition

Trial Locations

Locations (1)

Lille University Hospital; 🇫🇷 Lille, France