Reperfusion Therapy in Acute Ischemic Stroke With Unclear Onset (RESTORE)
This study will test the hypothesis whether patients with unclear-onset stroke (UnCLOS) treated with thrombolysis could achieve a prespecified rate of good clinical outcome. The secondary hypothesis is that the efficacy outcomes in UnCLOS group would be superior to those in historical UnCLOS group from prospective stroke registries.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||REperfusion Therapy in Acute Ischemic STroke With Unclear Onset by MRI Evaluation|
- Good clinical outcome defined as modified Rankin Scale 0-2 [ Time Frame: 3 months after treatment ] [ Designated as safety issue: No ]
- Symptomatic intracranial hemorrhage [ Time Frame: 48 hours after treatment ] [ Designated as safety issue: Yes ]
|Study Start Date:||October 2006|
|Study Completion Date:||June 2009|
|Primary Completion Date:||June 2009 (Final data collection date for primary outcome measure)|
|Acute ischemic stroke patients with unclear onset|
- 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