| September 8, 2005 |
| May 12, 2008 |
| August 2004 |
| March 2008 (final data collection date for primary outcome measure) |
- Modified Rankin Scale (MRS) score [ Time Frame: at 3 months ] [ Designated as safety issue: Yes ]
- Symptomatic intracranial hemorrhage [ Time Frame: for the initial 3 weeks ] [ Designated as safety issue: Yes ]
|
- Modified Rankin Scale score at 3 months
- Symptomatic intracranial hemorrhage for the initial 3 weeks
|
| Complete list of historical versions of study NCT00153946 on ClinicalTrials.gov Archive Site |
- NIHSS score, JSS score, Barthel Index, modified Rankin Scale score [ Time Frame: at various time-points ] [ Designated as safety issue: Yes ]
- Various adverse effects [ Time Frame: for the 3 months ] [ Designated as safety issue: Yes ]
|
- NIHSS score, JSS score, Barthel Index, modified Rankin Scale score at various time-points
- Various adverse effects for the 3 months
|
| |
| Edaravone and Argatroban Stroke Therapy Study for Acute Ischemic Stroke |
| 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. |
| |
| Phase IV |
| Interventional |
| Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Stroke |
| Drug: Edaravone |
- Active Comparator: The patients who are allocated to Argatroban monotherapy
- Active Comparator: The patients who are allocated to Edaravone-Argatroban combination therapy
|
| |
| |
| Completed |
| 814 |
| May 2008 |
| March 2008 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
|
| Both |
| 20 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| Japan |
| |
| NCT00153946 |
| Takenori Yamaguchi, M.D., President Emeritus, National Cardiovascular Center |
| EAST |
| Combination Therapy for Acute Ischemic Stroke Study Group |
| Japan Cardiovascular Research Foundation |
| Study Chair: |
Takenori Yamaguchi, MD, PhD |
National Cardiovascular Center |
|
| Principal Investigator: |
Takenori Yamaguchi, MD, PhD |
National Cardiovascular Center |
|
|
| Combination Therapy for Acute Ischemic Stroke Study Group |
| May 2008 |