StrokePhase 4EASTNCT00153946
Edaravone and Argatroban Stroke Therapy Study for Acute Ischemic Stroke
A Phase 4 study testing Edaravone in people with Stroke, run by Combination Therapy for Acute Ischemic Stroke Study Group at 1 site in Japan.
Trial summary
Edaravone, a free radical scavenger, is a novel neuroprotective agent, and argatroban is a selective thrombin inhibitor. Both the drugs were approved by the Japanese Government, and have frequently been used for the treatment of acute brain infarction in Japan. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Edaravone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 814 participants
- Where
- 1 siteJapan
- Study dates
- Aug 2004to May 2008
- Phase
- Phase 4
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute ischemic stroke < 24 hours of onset
- Measurable neurological deficits caused by the present attack, ranging from 1 to 22 of NIHSS score on admission
Who cannot join
- Definite or possible cardiogenic brain infarction
- Definite lacunar infarction
- Prior ischemic stroke within 6 months
- Evidence of hemorrhagic brain infarction, epidural hematoma, intracerebral hematoma, or intraventricular hemorrhage
- Severe consciousness disturbances (semicoma to deep coma)
- Neurological signs clearing spontaneously
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- Disability of 2 or more on mRS score before the index stroke aPTT being out of the normal range or 1.5 times longer than the pretreatment value
- If taking an oral anticoagulant, INR being 1.6 or more, or no INR data
- Treatment with urokinase, t-PA, heparin, ozagrel sodium, warfarin, or antiplatelet except for aspirin before enrollment
- Intravascular surgery, surgical operation, hyperbaric oxygen therapy, or hypothermia therapy before enrollment
- Serum creatinine >1.5 mg/dL
- Severe hepatic or cardiac disorders, infectious disorders, dehydration, etc.
- Neoplasm
- Pregnancy
- Hypersensitivity to test drugs
Trial locations and contacts
1 site in 1 country.
Japan1 site
EAST Study Office c/o National Cardiovascular Center
Suita, Osaka, 565-8565
About this study
Official title: Multicenter Randomized Open-Label Comparison Study on the Efficacy and Safety of Argatroban Monotherapy With Argatroban-Edaravone Combination Therapy
Edaravone, a free radical scavenger, is a novel neuroprotective agent, and argatroban is a selective thrombin inhibitor. Both the drugs were approved by the Japanese Government, and have frequently been used for the treatment of acute brain infarction in Japan. The effect of combination therapy of these drugs, however, has not yet been elucidated. This study will test the safety and efficacy of the combination therapy with these agents in patients with acute non-cardioembolic and non-lacunar ischemic stroke.
- Conditions
- Stroke
- Being tested
- Edaravone
- Keywords
- Free Radical Scavenger, Selective Thrombin Inhibitor, Acute ischemic stroke (nonlacunar and noncardioembolic)
- 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.
EdaravoneDrug
30mg/20mL vial, twice per day, not longer than two weeks
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | The patients who are allocated to Argatroban monotherapy Receives: Drug: Edaravone |
| B | Active comparator | The patients who are allocated to Edaravone-Argatroban combination therapy Receives: Drug: Edaravone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Rankin Scale (MRS) score
Measured: at 3 months
Symptomatic intracranial hemorrhage
Measured: for the initial 3 weeks
Secondary outcomes (2)
NIHSS score, JSS score, Barthel Index, modified Rankin Scale score
Measured: at various time-points
Various adverse effects
Measured: for the 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startAug 2004
- Primary completionMar 2008
- Study completionMay 2008
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 StrokeStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 814 participants (actual)
Sponsor and investigators
- Lead sponsor
- Combination Therapy for Acute Ischemic Stroke Study Group
- Sponsor type
- University, hospital or other
- Collaborators
- Japan Cardiovascular Research Foundation
- Investigators
- Takenori Yamaguchi, MD, PhD, Study chair, National Cerebral and Cardiovascular Center, JapanTakenori Yamaguchi, MD, PhD, Principal investigator, National Cerebral and Cardiovascular Center, Japan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00153946
- Sponsor's protocol ID
- EAST
- Acronym
- EAST
- Status last verified
- May 2008
- First submitted
- 8 Sep 2005
- Last updated
- 14 May 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jin YJ, Mima T, Raicu V, Park KC, Shimizu K. Combined argatroban and edaravone caused additive neuroprotection against 15 min of forebrain ischemia in gerbils. Neurosci Res. 2002 May;43(1):75-9. doi: 10.1016/s0168-0102(02)00019-6.
PubMed 12074843Kumagai N, Origasa H, Nagao T, Takekawa H, Okuhara Y, Yamaguchi T. Prognostic significance of smoking in patients with acute ischemic stroke within 3 months of onset. J Stroke Cerebrovasc Dis. 2013 Aug;22(6):792-8. doi: 10.1016/j.jstrokecerebrovasdis.2012.04.010. Epub 2012 May 24.
PubMed 22633681
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Randomized Open-Label Comparison Study on the Efficacy and Safety of Argatroban Monotherapy With Argatroban-Edaravone Combination Therapy
- ClinicalTrials.gov ID
- NCT00153946
- Acronym / sponsor ID
- EAST / EAST
- Conditions
- Stroke
- Keywords
- Free Radical Scavenger, Selective Thrombin Inhibitor, Acute ischemic stroke (nonlacunar and noncardioembolic)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 814 participants (actual)
- Lead sponsor
- Combination Therapy for Acute Ischemic Stroke Study GroupUniversity, hospital or other
- Collaborators
- Japan Cardiovascular Research Foundation
- Study start
- Aug 2004
- Primary completion
- Mar 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 12 Sep 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.
Edaravone, a free radical scavenger, is a novel neuroprotective agent, and argatroban is a selective thrombin inhibitor. Both the drugs were approved by the Japanese Government, and have frequently been used for the treatment of acute brain infarction in Japan. The effect of combination therapy of these drugs, however, has not yet been elucidated. This study will test the safety and efficacy of the combination therapy with these agents in patients with acute non-cardioembolic and non-lacunar ischemic stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: EdaravoneThe patients who are allocated to Argatroban monotherapy |
| B | Active comparator | Drug: EdaravoneThe patients who are allocated to Edaravone-Argatroban combination therapy |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Acute ischemic stroke < 24 hours of onset
- Measurable neurological deficits caused by the present attack, ranging from 1 to 22 of NIHSS score on admission
Key exclusion criteria (15 listed)
- Definite or possible cardiogenic brain infarction
- Definite lacunar infarction
- Prior ischemic stroke within 6 months
- Evidence of hemorrhagic brain infarction, epidural hematoma, intracerebral hematoma, or intraventricular hemorrhage
- Severe consciousness disturbances (semicoma to deep coma)
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 |
|---|---|---|
| Edaravone30mg/20mL vial, twice per day, not longer than two weeks | Drug | A, B |
Primary outcome
Modified Rankin Scale (MRS) score
Time frame: at 3 months
Symptomatic intracranial hemorrhage
Time frame: for the initial 3 weeks
2 secondary outcomes
NIHSS score, JSS score, Barthel Index, modified Rankin Scale score
Time frame: at various time-points
Various adverse effects
Time frame: for the 3 months
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 14 May 2008.
- Background: PubMed 12074843Jin YJ, Mima T, Raicu V, Park KC, Shimizu K. Combined argatroban and edaravone caused additive neuroprotection against 15 min of forebrain ischemia in gerbils. Neurosci Res. 2002 May;43(1):75-9. doi: 10.1016/s0168-0102(02)00019-6.
- Derived from this study: PubMed 22633681Kumagai N, Origasa H, Nagao T, Takekawa H, Okuhara Y, Yamaguchi T. Prognostic significance of smoking in patients with acute ischemic stroke within 3 months of onset. J Stroke Cerebrovasc Dis. 2013 Aug;22(6):792-8. doi: 10.1016/j.jstrokecerebrovasdis.2012.04.010. Epub 2012 May 24.
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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.
Takenori Yamaguchi, MD, PhD study chair
National Cerebral and Cardiovascular Center, Japan
Takenori Yamaguchi, MD, PhD principal investigator
National Cerebral and Cardiovascular Center, Japan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Edaravone in people with Stroke, run by Combination Therapy for Acute Ischemic Stroke Study Group at 1 site in Japan.
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 2 inclusion and 15 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 14 May 2008. 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 Japan. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 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?
Modified Rankin Scale (MRS) score (time frame: at 3 months). The study lists 2 primary outcomes in all. 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 NCT00153946, 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 14 May 2008.