Clinical trial NCT05486351: Keeping Oral o Parental AnticoaguLation in the Acute Phase of Cardioembolic Ischemic Stroke
Official title: Keeping Oral o Parental AnticoaguLation in the Acute Phase of Cardioembolic Ischemic
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardioembolic Stroke
Anticoagulant Therapy
Stroke Recurrence
Haemorrhagic Transformation Stroke
Lead sponsor: Instituto de Investigación Hospital Universitario La Paz
Sponsor class: OTHER
Collaborators: name: Hospital Universitario La Paz
name: Daiichi Sankyo
name: Fundación Freno al ICTUS
First posted: 2022-08-03
Enrollment: 318
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with acute ischemic stroke, with a major cardioembolic source and previosly treated with oral or parental anticoagulants.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Ischemic stroke recurrence
timeFrame: 90 days
measure: Symptomatic haemorrhagic transformation
timeFrame: 90 days
Secondary outcomes:
measure: Early ischemic stroke recurrence
timeFrame: Day 1 or day 7
measure: Early symptomatic haemorrhagic transformation
timeFrame: Day 1 or day 7
measure: Early radiologic haemorrhagic transformation
timeFrame: Day 1 or day 7
measure: Systemic embolism
timeFrame: Day 1, day 7 or day 90
measure: Major extracraneal haemorrhagic complication
timeFrame: Day 1, day 7 or day 90
measure: Mortality
timeFrame: Day 7
measure: Neurologic status
timeFrame: Day 90
measure: Functional status
timeFrame: Day 90
Other outcomes:
Locations:
city: Paris
country: France
facility: Bichat Claude Bernard Hospital
city: Madrid
country: Spain
facility: Jimenez Diaz Fundation University Hospital
city: Madrid
country: Spain
facility: La Paz University Hospital
Study officials:
affiliation: Hospital Universitario La Paz
name: Ricardo Rigual Bobillo, MD
role: PRINCIPAL_INVESTIGATOR
References: