Lixiana Acute Stroke Evaluation Registry
Maneno muhimu
Kikemikali
Maelezo
The primary aim of the Lixiana Acute Stroke Evaluation Registry is to demonstrate the safety of edoxaban initiation within 5 days of cardioembolic stroke. Safety will be established by demonstrating low rates of hemorrhage in this setting. The secondary aim is to identify clinical, imaging and RNA transcript predictors of hemorrhagic transformation after cardioembolic stroke.
The Investigators hypothesize that initiation of edoxaban within 5 days of stroke/TIA will not be associated with increased symptomatic HT rates, relative to patients in whom anticoagulation is delayed. The Investigators further hypothesize that early edoxaban initiation will be associated with a lower rate of recurrent ischemic stroke than those in whom it is delayed. The Investigators also hypothesize that RNA expressed in leukocytes at time of stroke can stratify risk of HT in patients treated with edoxaban.
The Lixiana Acute Stroke Evaluation Registry (LASER) is a randomized controlled trial with an associated registry. Patients with previously known or newly diagnosed AF and acute ischemic stroke will be screened in the Emergency Departments or stroke units. A total of 150 male and female participants will be recruited. Informed consent will be obtained from the participant or substitute decision maker, in all cases prior to enrolment.
Participants will be randomized (2:1) to early (≤5 days; n=100) or delayed (6-14 days; n=50) edoxaban initiation. In participants randomized to early treatment, edoxaban will be initiated as soon as possible after the baseline MRI (maximum 24 hours). Participants will be treated with edoxaban (60 mg once daily). If the eGFR is ≤50 ml/min kg or body weight ≤60 kg, the edoxaban dose will be reduced to 30 mg once daily.
The primary endpoint is the rate of symptomatic hemorrhagic transformation (HT) defined as a parenchymal haemorrhage >1/3 the volume of the ischemic infarct (ECASS PH2) associated with clinical deterioration (worsening of NIHSS score of 4 or more points) within 30 days of treatment initiation.
Tarehe
| Imethibitishwa Mwisho: | 04/30/2020 |
| Iliyowasilishwa Kwanza: | 04/03/2018 |
| Uandikishaji uliokadiriwa Uliwasilishwa: | 04/03/2018 |
| Iliyotumwa Kwanza: | 04/10/2018 |
| Sasisho la Mwisho Liliwasilishwa: | 05/11/2020 |
| Sasisho la Mwisho Lilichapishwa: | 05/13/2020 |
| Tarehe halisi ya kuanza kwa masomo: | 11/03/2018 |
| Tarehe ya Kukamilisha Msingi iliyokadiriwa: | 12/30/2020 |
| Tarehe ya Kukamilisha Utafiti: | 12/30/2021 |
Hali au ugonjwa
Uingiliaji / matibabu
Drug: Edoxaban 60 MG
Drug: Edoxaban 30 mg
Awamu
Vikundi vya Arm
| Mkono | Uingiliaji / matibabu |
|---|---|
| Other: Early initiation of edoxaban Participants will be initiated on edoxaban within ≤ 5 days following ischemic stroke | |
| Other: Delayed initiation of edoxaban Participants will be initiated on edoxaban within 6-14 days following ischemic stroke |
Vigezo vya Kustahiki
| Zama zinazostahiki Kujifunza | 18 Years Kwa 18 Years |
| Jinsia Inastahiki Kujifunza | All |
| Njia ya sampuli | Probability Sample |
| Hupokea Wajitolea wa Afya | Ndio |
| Vigezo | Inclusion Criteria: - Male or female patients - 18 years of age or older - Diagnosis of minor ischemic stroke, or Transient Ischemic Attack (TIA, defined as acute focal neurological deficits, with complete resolution of symptoms within 24 h of onset) confirmed ≤5 days from symptom onset. In cases where onset time cannot be established, it will be considered to be the time when patient was last known to be well. - CT scan or MRI, with findings consistent with an ischemic etiology of symptoms. - Atrial Fibrillation (AF, paroxysmal or persistent), confirmed with ECG/Holter monitor, or by history (clinical documentation of previous AF must be provided). - Patients prescribed edoxaban by their treating physician following their stroke/TIA. - Ability to obtain consent from patient or legally authorized representative. Exclusion Criteria: - Acute or chronic renal failure, defined as eGFR <30 ml/min (Cockcroft Gault formula). - Known hypersensitivity to edoxaban. - Any significant ongoing systemic bleeding risk, i.e. active GI/GU bleeding or recent major surgery. - Any condition that, in the judgment of the investigator could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study. - Recent past history or clinical presentation of ICH, subarachnoid haemorrhage (SAH), arterio-venous (AV) malformation, aneurysm, or cerebral neoplasm. At the discretion of each Investigator. - Hereditary or acquired haemorrhagic diathesis. - Stroke mimics (such as seizures, migraine etc.) - Patients with spontaneous HT with a grade of PH1 or PH2 on the baseline or screening imaging will not be eligible for randomization. They will be included in the registry portion of LASER and follow-up will be identical to that in the trial. |
Matokeo
Hatua za Matokeo ya Msingi
1. Rate of symptomatic hemorrhagic transformation (HT) [Within 30 days of treatment initiation.]
