Keeping Oral o Parental AnticoaguLation in the Acute Phase of Cardioembolic Ischemic Stroke

Study Overview
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Brief Summary
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This is an observational, prospective, multicenter, cohort study in patients with cardioembolic stroke and previous oral or parenteral anticoagulant therapy. Patients in which anticoagulante therapy is mantained will be compared to those in which it is interrupted, in terms of stroke or systemic embolism and haemorrhagic transformation.

Detailed Description
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Observational, prospective, multicenter, cohort study in patients with recent cardioembolic stroke (<24 hours) and previous oral or parenteral anticoagulant therapy (last dose recieved <24hours) . Patients in which anticoagulante therapy is mantained will be compared to those in which it is interrupted. The decision to mantain or interrumpt the anticoagulant therapy is made by the treating physician as hospital protocol. Stroke recurrence, haemorrhagic transformation at 90 days are evalauted and also complication during the hospitalization and functional outcome.

Official Title
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Keeping Oral o Parental AnticoaguLation in the Acute Phase of Cardioembolic Ischemic

Conditions
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Cardioembolic Stroke, Stroke Recurrence, Anticoagulant Therapy, Haemorrhagic Transformation Stroke

Intervention / Treatment
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* Other: Observation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ischemic stroke of less than 24 hours since beginning of symptoms or last seen normal Mayor cardioembolic source (atrial fibrilation or flutter, mechanical heart valve prosthesis, recient miocardic infarction, rheumatic mitral valve stenosis, dilated cardiomyopathy, atrial myxoma, left ventricular focal akynesia. Previous treatment with oral anticoagulants (vitamin K antagonists or direct oral anticoagulants), having received the last dose within the previous 24 hours. Treatment with intravenous or subcutaneos heparin is also valid. Age >18 years-old Signed informed consent (by patient or representative) Exclusion Criteria: History of Intracraneal or extracraneal haemorrhage that contraindicates anticoagulant therapy Patients treated with intravenous thrombolysis as a reperfusion therapy Intracraneal haemorrhage on initial CT scan Health status with a short survival prevision Patients in which a neurosurgery intervention could be indicated Child-bearing woman or in breast-feeding period.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Mantainance of anticoagulation therapy<br>Patients with acute ischemic stroke of cardioembolic source and previosly anticoagulated in which anticoagulant therapy is mantained | Other: Observation<br>* Patients are observed for stroke or systemic embolism and haemorrhagic transformation<br>|
| Interruption of anticoagulation therapy<br>Patients with acute ischemic stroke of cardioembolic source and previosly anticoagulated in which anticoagulant therapy is interrupted. | Other: Observation<br>* Patients are observed for stroke or systemic embolism and haemorrhagic transformation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ischemic stroke recurrence | recurrence of ischemic stroke noticied by changes in neurologic status and supported by neuroimaging | 90 days | 
| Symptomatic haemorrhagic transformation | Symptomatic haemorrhagic transformation defined by the SITS criteria and supported by neuroimaging | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early ischemic stroke recurrence | Recurrence of ischemic stroke at days 1 or day 7 | Day 1 or day 7 | 
| Early symptomatic haemorrhagic transformation | Symptomatic transformation ocurring on day 1 or day 7 | Day 1 or day 7 | 
| Early radiologic haemorrhagic transformation | Parenchymal haematoma (type PH1 or PH2) on control neuroimaging performed at 24h (if mechanical thromectomy performed) and at day 7 | Day 1 or day 7 | 
| Systemic embolism | Clinical, radiologic or analytic findings that suggest an ischemic event (myocardic, renal, splenic, bowl or limb infarctions | Day 1, day 7 or day 90 | 
| Major extracraneal haemorrhagic complication | intraocular, intraspinal, pericardic, intra-articular, intra-muscular with compartimental syndrome, retro-peritoneal bleeding that requires surgery or that causes death. Definition according to ISTH criteria | Day 1, day 7 or day 90 | 
| Mortality | Death | Day 7 | 
| Neurologic status | NIHSS scale | Day 90 | 
| Functional status | modified Rankin scale | Day 90 |