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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by University Hospital, Lille.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
University Hospital, Lille
ClinicalTrials.gov Identifier:
NCT01614080
First received: April 23, 2012
Last updated: June 4, 2012
Last verified: January 2012
  Purpose

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).


Condition
Stroke, Acute
Drug Toxicity

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by University Hospital, Lille:

Primary Outcome Measures:
  • OPHELIE [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
    The proportion of the patients with modified Rankin Scale 0-1


Secondary Outcome Measures:
  • OPHELIE [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    The proportion of the patients with symptomatic intra cerebral haemorrhage according to ECASS 2 definition


Estimated Enrollment: 700
Study Start Date: November 2011
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients treated in routine by iv t-PA for acute ischaemic stroke

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01614080

Contacts
Contact: Didier LEYS, MD, PhD +33320446813 didier.leys@chru-lille.fr
Contact: Anne-Marie BORDET +33320446814 am-bordet@chru-lille.fr

Locations
France
Lille University Hospital Recruiting
Lille, France, 59037
Contact: Didier LEYS, MD, PhD    +33320446813    didier.leys@chru-lille.fr   
Sub-Investigator: Christian LUCAS, MD, PhD         
Sub-Investigator: Hilde HENON, MD, PhD         
Sub-Investigator: Charlotte CORDONNIER, MD, PhD         
Sub-Investigator: Marie F GIROT, MD, PhD         
Sub-Investigator: Regis BORDET, MD, PhD         
Sub-Investigator: Dominique DEPLANQUE, MD, PhD         
Sub-Investigator: David DEVOS, Md, PhD         
Sub-Investigator: Marie BODENANT, MD         
Sub-Investigator: Nelly DEQUATRE, MD         
Sponsors and Collaborators
University Hospital, Lille
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
Study Director: Kei MURAO, MD University Lille 2
Study Chair: Denis VIVIEN, PhD Institut National de la Santé Et de la Recherche Médicale, France
Principal Investigator: Didier LEYS, MD, PhD Lille University Hospital
  More Information

No publications provided

Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT01614080     History of Changes
Other Study ID Numbers: 10.677, 2010_04
Study First Received: April 23, 2012
Last Updated: June 4, 2012
Health Authority: France: The Commission nationale de l’informatique et des libertés

Keywords provided by University Hospital, Lille:
Stroke
Ischemic stroke
thrombolysis
toxicity of t-PA

Additional relevant MeSH terms:
Cerebral Infarction
Brain Ischemia
Drug-Related Side Effects and Adverse Reactions
Ischemia
Stroke
Brain Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Chemically-Induced Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on July 31, 2014