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| Name | Class |
|---|---|
| Hospital Universitario La Paz | OTHER |
| Daiichi Sankyo | INDUSTRY |
| Fundación Freno al ICTUS | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mantainance of anticoagulation therapy | Patients with acute ischemic stroke of cardioembolic source and previosly anticoagulated in which anticoagulant therapy is mantained |
| |
| Interruption of anticoagulation therapy | Patients with acute ischemic stroke of cardioembolic source and previosly anticoagulated in which anticoagulant therapy is interrupted. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observation | Other | Patients are observed for stroke or systemic embolism and haemorrhagic transformation |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with acute ischemic stroke, with a major cardioembolic source and previosly treated with oral or parental anticoagulants.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ricardo Rigual Bobillo, MD | Contact | 917277444 | +34 | ricardojaime.rigual@salud.madrid.org |
| Elena de Celis Ruiz, MD | Contact | 917277444 | +34 | elena.decelis.ruiz@idipaz.es |
| Name | Affiliation | Role |
|---|---|---|
| Ricardo Rigual Bobillo, MD | Hospital Universitario La Paz | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bichat Claude Bernard Hospital | Active, not recruiting | Paris | 75018 | France | ||
| Jimenez Diaz Fundation University Hospital |
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| ID | Term |
|---|---|
| D000083262 | Embolic Stroke |
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
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| ID | Term |
|---|---|
| D019370 | Observation |
| ID | Term |
|---|---|
| D008722 | Methods |
| D008919 | Investigative Techniques |
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Blood samples for levels of anticoagulant medications and/or INR testing
| 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 |
| Recruiting |
| Madrid |
| 28040 |
| Spain |
|
| La Paz University Hospital | Recruiting | Madrid | 28046 | Spain |
|
| D002493 |
| Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |