Reperfusion Therapy in Acute Ischemic Stroke With Unclear Onset (RESTORE)
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|ClinicalTrials.gov Identifier: NCT01138059|
Recruitment Status : Completed
First Posted : June 7, 2010
Last Update Posted : June 7, 2010
|Condition or disease|
- Study design: A prospective multicenter trial
- Study centers: 6 participating medical centers in South Korea
- Participants: Consecutive patients with acute ischemic stroke visiting the emergency room within 6 hours of the detection of stroke symptoms
3 thrombolysis protocols applicable to UnCLOS patients
- IV tissue plasminogen activator (tPA) : Conventional intravenous tPA (0.9 mg/kg, 10% of the dose as a bolus and the remainder over 60 minutes) will be administered to patients within 3 hours of first found abnormal time who had no arterial occlusion or catheter-inaccessible occlusion.
- IV tPA + IA urokinase protocol : Combined intravenous tPA (0.6 mg/kg, 10% of the dose as a bolus and the remainder over 30 minutes) with intra-arterial urokinase will be administered to those within 3 hours from first found abnormal time who had catheter-accessible arterial occlusion.
- IA UK protocol : Intra-arterial urokinase will be given to those between 3 and 6 hours after first found abnormal time who had catheter-accessible arterial occlusion.
- Safety outcomes Symptomatic intracranial hemorrhage (ICH) within 48 hours from thrombolytic therapy.
- Long-term clinical outcomes (modified Rankin Scale) at 3 months
- Secondary efficacy outcomes : Good vs. Poor outcomes according to mRS responder analysis, Early neurological improvement, Immediate and 5-day recanalization on MRA or CTA
|Study Type :||Observational|
|Actual Enrollment :||83 participants|
|Official Title:||REperfusion Therapy in Acute Ischemic STroke With Unclear Onset by MRI Evaluation|
|Study Start Date :||October 2006|
|Actual Primary Completion Date :||June 2009|
|Actual Study Completion Date :||June 2009|
|Acute ischemic stroke patients with unclear onset|
- Good clinical outcome defined as modified Rankin Scale 0-2 [ Time Frame: 3 months after treatment ]
- Symptomatic intracranial hemorrhage [ Time Frame: 48 hours after treatment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01138059
|Principal Investigator:||Dong-Wha Kang, MD, PhD||Asan Medical Center|