Reperfusion Therapy in Acute Ischemic Stroke With Unclear Onset (RESTORE)
REperfusion Therapy in Acute Ischemic STroke With Unclear Onset by MRI Evaluation
Panoramica dello studio
Stato
Stato
Condizioni
Condizioni
Descrizione dettagliata
- 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
Methods
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.
Outcome variables
- Safety outcomes Symptomatic intracranial hemorrhage (ICH) within 48 hours from thrombolytic therapy.
Efficacy outcomes
- 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
Tipo di studio
Tipo di studio
Iscrizione (Effettivo)
Iscrizione
Criteri di partecipazione
Criteri di ammissibilità
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- The patient is male or female and age between 18 and 85 years
- The patient has unclear onset stroke
- Treatment of the patient can be initiated within 6 hours after first found abnormal time
- The patient has imaging-defined penumbra (at least 20%), measured by diffusion- and perfusion-weighted MRI
Exclusion Criteria:
- The patient has minor neurologic deficits (NIHSS <4, except aphasia or hemianopia).
- The patient has rapidly resolving neurological symptoms and the rate of improvement is projected to give the patient an NIHSS score <4 at the time of treatment.
- The patient has a pre-stroke mRS score of >1 (indicating previous disability).
- The symptoms of stroke are suggestive of subarachnoid hemorrhage.
- Evidence of infective endocarditis or septic embolism
- The patient has a history or clinical presentation of ICH, SAH, or AVM.
- Serious head trauma within 6 weeks
- Prior ischemic stroke in previous 6 weeks (except small infarct)
- Myocardial infarction in the previous 3 weeks
- Gastrointestinal or urinary tract bleeding in previous 21 days
- Major surgery in the previous 14 days
- History of biopsy of a parenchymal organ, trauma with internal organ injury or lumbar puncture within 14 days
- Arterial puncture at a non-compressible site in the previous 7 days
- Uncontrolled high blood pressure (systolic > 185 mmHg or diastolic > 110 mmHg on 3 separate occasions at least 10 min apart despite appropriate treatment)
- Evidence of active bleeding or acute trauma (fracture) on examination
- Current use of oral anticoagulants and a prolonged prothrombin time (INR >1.7)
- The patient has been treated with heparin in the previous 48 hours with prolonged aPTT, except for low dose subcutaneous LMWH with doses recommended for DVT prophylaxis
- Baseline platelet count < 100,000 mm3
- Baseline hematocrit < 25%
- Blood glucose concentration < 50 mg/dL (2.7 mmol/L) in case of CT screening
- Seizure at onset with postictal residual neurological impairments in case of CT screening
- The patient has a terminal illness.
- The patient is, in the opinion of the investigator, unlikely to comply with the clinical study protocol or is unsuitable for any other reason.
- The patient has extensive early infarction in any affected area defined as an infarcted core involving > 1/3 of MCA territory or the entire ACA or PCA territory
- The patient has well-developed parenchymal hyperintensity on FLAIR, T2*, or EPI-T2 images, or marked hypodensity on CT, indicative of subacute infarction, or enhancement with morphologic features suggesting the lesion is more than 6 hours old
- The patient has a contraindication to the imaging techniques (this means ferromagnetic objects for MRI, contraindications to contrast agent, renal disease with iodinated contrast agent in perfusion CT and CTA, etc.)
- The patient has imaging evidence of ICH or SAH, AVM, brain tumor (Incidental meningioma and microbleeds are not exclusion criteria. Incidental unruptured aneurysm that is small (< 5mm) is not an exclusion criterion).
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Numero di gruppi/coorti
Coorti e interventi
Gruppo / CoorteGruppo / Coorte |
|---|
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Acute ischemic stroke patients with unclear onset
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Good clinical outcome defined as modified Rankin Scale 0-2
Lasso di tempo: 3 months after treatment
|
3 months after treatment
|
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Symptomatic intracranial hemorrhage
Lasso di tempo: 48 hours after treatment
|
48 hours after treatment
|
Collaboratori e investigatori
Sponsor
Sponsor
Collaboratori
Collaboratori
Studiare le date dei record
Studia le date principali
Inizio studio
Inizio studio
Completamento primario (Effettivo)
Completamento primario
Completamento dello studio (Effettivo)
Completamento dello studio
Date di iscrizione allo studio
Primo inviato
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Primo Inserito
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento pubblicato
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
Altri numeri di identificazione dello studio
- AMC-2004-217
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