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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cardioembolic Stroke; Stroke Recurrence; Anticoagulant Therapy; Haemorrhagic Transformation Stroke
• Intervention / Treatment: Other: Observation

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 Type: Observational
• Enrollment (Anticipated): 318

Contacts and Locations

Study Locations

• France
  • Paris, France, 75018
    • Active, not recruiting
    • Bichat Claude Bernard Hospital
• Spain
  • Madrid, Spain, 28046
    • Recruiting
    • La Paz University Hospital
  • Madrid, Spain, 28040
    • Recruiting
    • Jimenez Diaz Fundation University Hospital
    • Contact: Ricardo Rigual Bobillo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Mantainance of anticoagulation therapy; Patients with acute ischemic stroke of cardioembolic source and previosly anticoagulated in which anticoagulant therapy is mantained	Other: Observation; 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.	Other: Observation; Patients are observed for stroke or systemic embolism and haemorrhagic transformation

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Instituto de Investigación Hospital Universitario La Paz
• Collaborators: Daiichi Sankyo, Inc.; Hospital Universitario La Paz; Fundación Freno al ICTUS

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 5, 2021
• Primary Completion (ANTICIPATED): December 31, 2023
• Study Completion (ANTICIPATED): December 31, 2023

Study Registration Dates

• First Submitted: August 2, 2022
• First Submitted That Met QC Criteria: August 2, 2022
• First Posted (ACTUAL): August 3, 2022

Study Record Updates

• Last Update Posted (ACTUAL): August 3, 2022
• Last Update Submitted That Met QC Criteria: August 2, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Disease Attributes; Ischemic Stroke; Stroke; Recurrence; Embolic Stroke
• Other Study ID Numbers: PI-4056

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No