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

Anticoagulant Therapy Clinical Trial

— KOALA-IS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05486351
• Other study ID #: PI-4056
• Status: Recruiting
• Start date: March 5, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: July 2022
• Source: Instituto de Investigación Hospital Universitario La Paz
• Contact: Ricardo Rigual Bobillo, MD
• Phone: 917277444
• Email: ricardojaime.rigual[@]salud.madrid.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 318
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anticoagulant Therapy
• Cardioembolic Stroke
• Embolic Stroke
• Recurrence
• Stroke
• Stroke Recurrence

Intervention

Other:
• Observation
Patients are observed for stroke or systemic embolism and haemorrhagic transformation

Locations

Country	Name	City	State
France	Bichat Claude Bernard Hospital	Paris
Spain	Jimenez Diaz Fundation University Hospital	Madrid
Spain	La Paz University Hospital	Madrid

Sponsors (4)

Lead Sponsor	Collaborator
Instituto de Investigación Hospital Universitario La Paz	Daiichi Sankyo, Inc., Fundación Freno al ICTUS, Hospital Universitario La Paz

Countries where clinical trial is conducted

France,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ischemic stroke recurrence	recurrence of ischemic stroke noticied by changes in neurologic status and supported by neuroimaging	90 days
Primary	Symptomatic haemorrhagic transformation	Symptomatic haemorrhagic transformation defined by the SITS criteria and supported by neuroimaging	90 days
Secondary	Early ischemic stroke recurrence	Recurrence of ischemic stroke at days 1 or day 7	Day 1 or day 7
Secondary	Early symptomatic haemorrhagic transformation	Symptomatic transformation ocurring on day 1 or day 7	Day 1 or day 7
Secondary	Early radiologic haemorrhagic transformation	Parenchymal haematoma (type PH1 or PH2) on control neuroimaging performed at 24h (if mechanical thromectomy performed) and at day 7	Day 1 or day 7
Secondary	Systemic embolism	Clinical, radiologic or analytic findings that suggest an ischemic event (myocardic, renal, splenic, bowl or limb infarctions	Day 1, day 7 or day 90
Secondary	Major extracraneal haemorrhagic complication	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	Day 1, day 7 or day 90
Secondary	Mortality	Death	Day 7
Secondary	Neurologic status	NIHSS scale	Day 90
Secondary	Functional status	modified Rankin scale	Day 90