Stroke, AcutePhase 2NCT00132509
FRALYSE Trial: Comparison of the Classical Rt-PA Procedure With a Longer Procedure in Acute Ischemic Stroke
A Phase 2 study testing DFIL and NINDS in people with Stroke, Acute, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Data from the literature have suggested that a longer time of thrombolysis might be more effective in ischemic stroke. We, the investigators at Hospices Civils de Lyon, have designed a randomized protocol to test this hypothesis. Moreover, the therapeutic window is 7 hours. Read more about this study
- Who is it for?
- Ages 18 to 81 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke, Acute
- What is being tested?
- DFIL and NINDS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2001to Aug 2008
- Phase
- Phase 2
- 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 to 81 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Symptoms of ischemic stroke
- Presence of a deficit measurable with National Institutes of Health Stroke Scale (NIHSS)
- Lack of any hemorrhagic lesion on the computed tomography (CT) scan at entry
- Time of therapy less than 7 hours after onset of stroke
- Permanent or aggravating symptoms
- Ages 18-81
Who cannot join
- Lack of cerebral infarction or of cranial trauma within 3 weeks before therapy
- No surgery within 14 days before therapy
- History of cerebral bleeding
- Blood pressure: systolic >185 mmHg and/or diastolic >110 mmHg
- Minor symptoms or symptoms rapidly improving
- Gastro-intestinal or urinary hemorrhage within 21 days
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- Arterial puncture within 7 days before therapy
- Epileptic seizure at the beginning of stroke
- Patients under oral anticoagulants or having received heparin within 48 hours, and with elevated activated partial thromboplastin time (aPTT)
- Patients with elevated International Normalized Ratio (INR) or thrombocyte count < 100 x 10^9
- Blood glucose value < 2.7 mmol/l or > 22.2 mmol/l
- Cardiac, pulmonary, hepatic or renal failure, not allowing a study over 3 months
- History of gastric ulcer within 15 days; gestation and menstruation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Classical Rt-PA Procedure (0.9mg/kg Over 60 Minutes) With a Longer Procedure With Lower Dose (0.8mg/kg Over 90 Minutes) in Acute Ischemic Stroke
Data from the literature have suggested that a longer time of thrombolysis might be more effective in ischemic stroke. We, the investigators at Hospices Civils de Lyon, have designed a randomized protocol to test this hypothesis. Moreover, the therapeutic window is 7 hours.
Rt-PA (alteplase) is injected intravenously in the 2 arms of the study for a duration of 60 minutes in the arm with a "classical dose" and 90 minutes in the arm with a "low dose-longer infusion".
This is a study of the outcome at 90 days.
- Conditions
- Stroke, Acute
- Being tested
- DFIL, NINDS
- Keywords
- rt-PA, thrombolysis, Acute ischemic stroke
- Medical subject headings
- Stroke, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DFILDrug
Alteplase : 0.8mg/kg over 90 minutes
NINDSDrug
Alteplase : 0.9mg/kg over 60 minutes
| Study group | Role | What they receive |
|---|---|---|
| DFIL | Experimental | Not described Receives: Drug: DFIL |
| NINDS | Active comparator | Not described Receives: Drug: NINDS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Rankin score
Measured: day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2005 (estimated)
- Study startSep 2001
- Primary completionAug 2008
- Study completionAug 2008
Why it stopped: End of promotion by the sponsor
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, AcuteStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Investigators
- Paul TROUILLAS, MD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00132509
- Sponsor's protocol ID
- 2000.208
- Status last verified
- Feb 2009
- First submitted
- 19 Aug 2005
- Last updated
- 22 Jul 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Classical Rt-PA Procedure (0.9mg/kg Over 60 Minutes) With a Longer Procedure With Lower Dose (0.8mg/kg Over 90 Minutes) in Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT00132509
- Acronym / sponsor ID
- 2000.208
- Conditions
- Stroke, Acute
- Keywords
- rt-PA, thrombolysis, Acute ischemic stroke
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: End of promotion by the sponsor
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Sep 2001
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 22 Aug 2005 (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.
Data from the literature have suggested that a longer time of thrombolysis might be more effective in ischemic stroke. We, the investigators at Hospices Civils de Lyon, have designed a randomized protocol to test this hypothesis. Moreover, the therapeutic window is 7 hours.
Rt-PA (alteplase) is injected intravenously in the 2 arms of the study for a duration of 60 minutes in the arm with a "classical dose" and 90 minutes in the arm with a "low dose-longer infusion".
This is a study of the outcome at 90 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DFIL | Experimental | Drug: DFIL |
| NINDS | Active comparator | Drug: NINDS |
Who may qualify
- Ages
- 18 to 81 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Symptoms of ischemic stroke
- Presence of a deficit measurable with National Institutes of Health Stroke Scale (NIHSS)
- Lack of any hemorrhagic lesion on the computed tomography (CT) scan at entry
- Time of therapy less than 7 hours after onset of stroke
- Permanent or aggravating symptoms
Key exclusion criteria (13 listed)
- Lack of cerebral infarction or of cranial trauma within 3 weeks before therapy
- No surgery within 14 days before therapy
- History of cerebral bleeding
- Blood pressure: systolic >185 mmHg and/or diastolic >110 mmHg
- Minor symptoms or symptoms rapidly improving
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DFILAlteplase : 0.8mg/kg over 90 minutes | Drug | DFIL |
| NINDSAlteplase : 0.9mg/kg over 60 minutes | Drug | NINDS |
Primary outcome
Modified Rankin score
Time frame: day 90
Results and safety
The study was stopped early (reason given: End of promotion by the sponsor). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2011.
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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.
Paul TROUILLAS, MD principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DFIL and NINDS in people with Stroke, Acute, run by Hospices Civils de Lyon 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 6 inclusion and 13 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: stopped early, as of the sponsor's last update on 22 Jul 2011. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: End of promotion by the sponsor). Results are not available in the source record.
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?
Modified Rankin score (time frame: day 90). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jul 2011.