Keeping Oral o Parental AnticoaguLation in the Acute Phase of Cardioembolic Ischemic Stroke (KOALA-IS)

Instituto de Investigación Hospital Universitario La Paz

Status: Enrolling

Conditions: Haemorrhagic Transformation Stroke; Cardioembolic Stroke; Stroke Recurrence; Anticoagulant Therapy

Treatments: Other: Observation

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05486351

PI-4056

Details and patient eligibility

About

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.

Full 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.

Enrollment: 318 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

318 participants in 2 patient groups

Mantainance of anticoagulation therapy

Description:

Patients with acute ischemic stroke of cardioembolic source and previosly anticoagulated in which anticoagulant therapy is mantained

Treatment:

Other: Observation

Interruption of anticoagulation therapy

Description:

Patients with acute ischemic stroke of cardioembolic source and previosly anticoagulated in which anticoagulant therapy is interrupted.

Treatment:

Other: Observation