Cardioembolic StrokeKOALA-ISNCT05486351
Keeping Oral o Parental AnticoaguLation in the Acute Phase of Cardioembolic Ischemic Stroke
An observational study of Cardioembolic Stroke and Anticoagulant Therapy, run by Instituto de Investigación Hospital Universitario La Paz at 3 sites in 2 countries.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardioembolic Stroke, Anticoagulant Therapy, Stroke Recurrence
- What is being tested?
- Observation
- How many people
- 318 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 5 Mar 2021to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with acute ischemic stroke, with a major cardioembolic source and previosly treated with oral or parental anticoagulants.
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Spain2 sites, 2 recruiting
- Recruiting
Jimenez Diaz Fundation University Hospital
Madrid, 28040
Ricardo Rigual Bobillo
- Recruiting
La Paz University Hospital
Madrid, 28046
Ricardo Rigual Bobillo, MD, 917277444 ext. +34, ricardojaime.rigual@salud.madrid.org
Elena de Celis Ruiz, MD, 917277444 ext. +34, elena.decelis.ruiz@idipaz.es
About this study
Official title: 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.
Read the 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.
- Conditions
- Cardioembolic Stroke, Anticoagulant Therapy, Stroke Recurrence, Haemorrhagic Transformation Stroke
- Being tested
- Observation
- Medical subject headings
- Embolic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
Patients are observed for stroke or systemic embolism and haemorrhagic transformation
| Study group | Role | What they receive |
|---|---|---|
| Mantainance of anticoagulation therapy | Patients with acute ischemic stroke of cardioembolic source and previosly anticoagulated in which anticoagulant therapy is mantained Receives: Other: Observation | |
| Interruption of anticoagulation therapy | Patients with acute ischemic stroke of cardioembolic source and previosly anticoagulated in which anticoagulant therapy is interrupted. Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ischemic stroke recurrence
recurrence of ischemic stroke noticied by changes in neurologic status and supported by neuroimaging
Measured: 90 days
Symptomatic haemorrhagic transformation
Symptomatic haemorrhagic transformation defined by the SITS criteria and supported by neuroimaging
Measured: 90 days
Secondary outcomes (8)
Early ischemic stroke recurrence
Recurrence of ischemic stroke at days 1 or day 7
Measured: Day 1 or day 7
Early symptomatic haemorrhagic transformation
Symptomatic transformation ocurring on day 1 or day 7
Measured: 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
Measured: Day 1 or day 7
Systemic embolism
Clinical, radiologic or analytic findings that suggest an ischemic event (myocardic, renal, splenic, bowl or limb infarctions
Measured: 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
Measured: Day 1, day 7 or day 90
Mortality
Death
Measured: Day 7
Neurologic status
NIHSS scale
Measured: Day 90
Functional status
modified Rankin scale
Measured: Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2022
- Study start5 Mar 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardioembolic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 318 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Hospital Universitario La Paz
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario La Paz, Daiichi Sankyo, Fundación Freno al ICTUS
- Responsible party
- Sponsor
- Investigators
- Ricardo Rigual Bobillo, MD, Principal investigator, Hospital Universitario La Paz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05486351
- Sponsor's protocol ID
- PI-4056
- Acronym
- KOALA-IS
- Status last verified
- Jul 2022
- First submitted
- 2 Aug 2022
- Last updated
- 3 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Keeping Oral o Parental AnticoaguLation in the Acute Phase of Cardioembolic Ischemic
- ClinicalTrials.gov ID
- NCT05486351
- Acronym / sponsor ID
- KOALA-IS / PI-4056
- Conditions
- Cardioembolic Stroke, Anticoagulant Therapy, Stroke Recurrence, Haemorrhagic Transformation Stroke
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 318 participants (estimated)
- Lead sponsor
- Instituto de Investigación Hospital Universitario La PazUniversity, hospital or other
- Collaborators
- Hospital Universitario La Paz, Daiichi Sankyo, Fundación Freno al ICTUS
- Study start
- 5 Mar 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 3 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mantainance of anticoagulation therapy | – | Other: ObservationPatients with acute ischemic stroke of cardioembolic source and previosly anticoagulated in which anticoagulant therapy is mantained |
| Interruption of anticoagulation therapy | – | Other: ObservationPatients with acute ischemic stroke of cardioembolic source and previosly anticoagulated in which anticoagulant therapy is interrupted. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with acute ischemic stroke, with a major cardioembolic source and previosly treated with oral or parental anticoagulants.
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationPatients are observed for stroke or systemic embolism and haemorrhagic transformation | Other | Interruption of anticoagulation therapy, Mantainance of anticoagulation therapy |
Primary outcome
Ischemic stroke recurrence
Time frame: 90 days
recurrence of ischemic stroke noticied by changes in neurologic status and supported by neuroimaging
Symptomatic haemorrhagic transformation
Time frame: 90 days
Symptomatic haemorrhagic transformation defined by the SITS criteria and supported by neuroimaging
8 secondary outcomes
Early ischemic stroke recurrence
Time frame: Day 1 or day 7
Early symptomatic haemorrhagic transformation
Time frame: Day 1 or day 7
Early radiologic haemorrhagic transformation
Time frame: Day 1 or day 7
Systemic embolism
Time frame: Day 1, day 7 or day 90
Major extracraneal haemorrhagic complication
Time frame: Day 1, day 7 or day 90
Mortality
Time frame: Day 7
Neurologic status
Time frame: Day 90
Functional status
Time frame: Day 90
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ricardo Rigual Bobillo, MD principal investigator
Hospital Universitario La Paz
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardioembolic Stroke and Anticoagulant Therapy, run by Instituto de Investigación Hospital Universitario La Paz at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ricardo Rigual Bobillo, MD (917277444 ext. +34, ricardojaime.rigual@salud.madrid.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ischemic stroke recurrence (time frame: 90 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2022.