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

NCT ID: NCT05486351

Last Updated: 2022-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

318 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-05

Study Completion Date

2023-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cardioembolic Stroke Anticoagulant Therapy Stroke Recurrence Haemorrhagic Transformation Stroke

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Mantainance of anticoagulation therapy

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

Observation

Intervention Type OTHER

Patients are observed for stroke or systemic embolism and haemorrhagic transformation

Interruption of anticoagulation therapy

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

Observation

Intervention Type OTHER

Patients are observed for stroke or systemic embolism and haemorrhagic transformation

Interventions

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Observation

Patients are observed for stroke or systemic embolism and haemorrhagic transformation

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Universitario La Paz

OTHER

Sponsor Role collaborator

Daiichi Sankyo

INDUSTRY

Sponsor Role collaborator

Fundación Freno al ICTUS

UNKNOWN

Sponsor Role collaborator

Instituto de Investigación Hospital Universitario La Paz

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ricardo Rigual Bobillo, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario La Paz

Locations

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Bichat Claude Bernard Hospital

Paris, , France

Site Status ACTIVE_NOT_RECRUITING

Jimenez Diaz Fundation University Hospital

Madrid, , Spain

Site Status RECRUITING

La Paz University Hospital

Madrid, , Spain

Site Status RECRUITING

Countries

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France Spain

Central Contacts

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Ricardo Rigual Bobillo, MD

Role: CONTACT

917277444 ext. +34

Elena de Celis Ruiz, MD

Role: CONTACT

917277444 ext. +34

Facility Contacts

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Ricardo Rigual Bobillo

Role: primary

Ricardo Rigual Bobillo, MD

Role: primary

917277444 ext. +34

Elena de Celis Ruiz, MD

Role: backup

917277444 ext. +34

Other Identifiers

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PI-4056

Identifier Type: -

Identifier Source: org_study_id

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