Anticoagulant Therapy, Cardioembolic Stroke, Haemorrhagic Transformation Stroke, Stroke Recurrence
Conditions
Brief summary
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
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.
Interventions
OTHERObservation
Patients are observed for stroke or systemic embolism and haemorrhagic transformation
Sponsors
Hospital Universitario La Paz
Daiichi Sankyo
Fundación Freno al ICTUS
Instituto de Investigación Hospital Universitario La Paz
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ischemic stroke recurrence | 90 days | recurrence of ischemic stroke noticied by changes in neurologic status and supported by neuroimaging |
| Symptomatic haemorrhagic transformation | 90 days | Symptomatic haemorrhagic transformation defined by the SITS criteria and supported by neuroimaging |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Early ischemic stroke recurrence | Day 1 or day 7 | Recurrence of ischemic stroke at days 1 or day 7 |
| Early symptomatic haemorrhagic transformation | Day 1 or day 7 | Symptomatic transformation ocurring on day 1 or day 7 |
| Major extracraneal haemorrhagic complication | Day 1, day 7 or day 90 | 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 |
| Early radiologic haemorrhagic transformation | Day 1 or day 7 | Parenchymal haematoma (type PH1 or PH2) on control neuroimaging performed at 24h (if mechanical thromectomy performed) and at day 7 |
| Neurologic status | Day 90 | NIHSS scale |
| Functional status | Day 90 | modified Rankin scale |
| Mortality | Day 7 | Death |
| Systemic embolism | Day 1, day 7 or day 90 | Clinical, radiologic or analytic findings that suggest an ischemic event (myocardic, renal, splenic, bowl or limb infarctions |
Countries
France, Spain
Contacts
Primary ContactRicardo Rigual Bobillo, MD
Backup ContactElena de Celis Ruiz, MD
Outcome results
None listed