Stroke, AcuteOPHELIENCT01614080
Outcome of Patients Treated by iv Rt-PA for Cerebral Ischaemia According to the Ratio Sc-tPA/Tc-tPA
An observational study of Stroke, Acute and Drug Toxicity, run by University Hospital, Lille at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Acute, Drug Toxicity
- How many people
- 700 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2011to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients treated in routine by iv t-PA for acute ischaemic stroke
Who may be able to join
- Being treated by iv tPA for acute cerebral ischaemia
Who cannot join
- absence of reliable informant
- no rtPA left in the syringe after treatment
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
Read the 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.
- Conditions
- Stroke, Acute, Drug Toxicity
- Keywords
- Stroke, Ischemic stroke, thrombolysis, toxicity of t-PA
- Medical subject headings
- Stroke, Drug-Related Side Effects and Adverse Reactions, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
OPHELIE
The proportion of the patients with modified Rankin Scale 0-1
Measured: Month 3
Secondary outcomes (1)
OPHELIE
The proportion of the patients with symptomatic intra cerebral haemorrhage according to ECASS 2 definition
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2012 (estimated)
- Study startNov 2011
- Primary completionNov 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Stroke, AcuteStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 700 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kei MURAO, MD, Study director, University Lille 2Denis VIVIEN, PhD, Study chair, Institut National de la Santé Et de la Recherche Médicale, FranceDidier LEYS, MD, PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01614080
- Sponsor's protocol ID
- 10.677
- Other IDs
- 2010_04
- Acronym
- OPHELIE
- Status last verified
- Dec 2014
- First submitted
- 23 Apr 2012
- Last updated
- 19 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 32015090Leys 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.
PubMed 27815401
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01614080
- Acronym / sponsor ID
- OPHELIE / 10.677
- Conditions
- Stroke, Acute, Drug Toxicity
- Keywords
- Stroke, Ischemic stroke, thrombolysis, toxicity of t-PA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 700 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- Nov 2011
- Primary completion
- Nov 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 7 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated in routine by iv t-PA for acute ischaemic stroke
Key inclusion criteria (1 listed)
- Being treated by iv tPA for acute cerebral ischaemia
Key exclusion criteria (2 listed)
- absence of reliable informant
- no rtPA left in the syringe after treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
OPHELIE
Time frame: Month 3
The proportion of the patients with modified Rankin Scale 0-1
1 secondary outcome
OPHELIE
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2014.
- Derived from this study: PubMed 32015090Caparros 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.
- Derived from this study: PubMed 27815401Leys 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kei MURAO, MD study director
University Lille 2
Denis VIVIEN, PhD study chair
Institut National de la Santé Et de la Recherche Médicale, France
Didier LEYS, MD, PhD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, Acute and Drug Toxicity, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OPHELIE (time frame: Month 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01614080, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2014.