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

• Conditions: Cardioembolic Stroke; Stroke Recurrence; Haemorrhagic Transformation Stroke; Anticoagulant Therapy
• Interventions: Other: Observation

• Registration Number: NCT05486351
• Lead Sponsor: Instituto de Investigación Hospital Universitario La Paz

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.

Study Timeline

• Study Start: 2021-03-05
• Status Verified: 2022-07
• Study First Submitted: 2022-08-02
• Study First Submitted QC: 2022-08-02
• Last Update Submitted: 2022-08-02
• Study First Posted: 2022-08-03
• Last Update Posted: 2022-08-03
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 318

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Mantainance of anticoagulation therapy	Observation	Patients with acute ischemic stroke of cardioembolic source and previosly anticoagulated in which anticoagulant therapy is mantained
Interruption of anticoagulation therapy	Observation	Patients with acute ischemic stroke of cardioembolic source and previosly anticoagulated in which anticoagulant therapy is interrupted.

Primary Outcome Measures

Name	Time	Method
Symptomatic haemorrhagic transformation	90 days	Symptomatic haemorrhagic transformation defined by the SITS criteria and supported by neuroimaging
Ischemic stroke recurrence	90 days	recurrence of ischemic stroke noticied by changes in neurologic status and supported by neuroimaging

Secondary Outcome Measures

Name	Time	Method
Early symptomatic haemorrhagic transformation	Day 1 or day 7	Symptomatic transformation ocurring on day 1 or day 7
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
Mortality	Day 7	Death
Neurologic status	Day 90	NIHSS scale
Functional status	Day 90	modified Rankin scale
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
Early ischemic stroke recurrence	Day 1 or day 7	Recurrence of ischemic stroke at days 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

Trial Locations

Locations (3)

Jimenez Diaz Fundation University Hospital; 🇪🇸 Madrid, Spain

Bichat Claude Bernard Hospital; 🇫🇷 Paris, France

La Paz University Hospital; 🇪🇸 Madrid, Spain