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.
1. Study design: A prospective multicenter trial
2. Study centers: 6 participating medical centers in South Korea
3. 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
1. 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.
2. 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.
3. 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.
5. Outcome variables
- Safety outcomes Symptomatic intracranial hemorrhage (ICH) within 48 hours from thrombolytic therapy.
- Efficacy outcomes
1. Long-term clinical outcomes (modified Rankin Scale) at 3 months
2. Secondary efficacy outcomes : Good vs. Poor outcomes according to mRS responder analysis, Early neurological improvement, Immediate and 5-day recanalization on MRA or CTA
- Observation: Case-Only
- Perspective: Prospective
- Sampling: Non-Probability Sample
Consecutive patients with acute ischemic stroke visiting the ER within 6 hours of the detection of stroke symptoms will be screened for this study.
|Type||Measure||Time Frame||Safety Issue|
|Primary||Good clinical outcome defined as modified Rankin Scale 0-2||3 months after treatment||No|
|Primary||Symptomatic intracranial hemorrhage||48 hours after treatment||Yes|