An observational study in Cardioembolic Stroke, Anticoagulant Therapy and Stroke Recurrence, sponsored by Instituto de Investigación Hospital Universitario La Paz. Status unknown at 3 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-03.
Sponsored by Instituto de Investigación Hospital Universitario La Paz · Observational
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.
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.
40 studies on the registry are indexed under Embolic Stroke; 11 are open to participants now.
This study's planned enrollment of 318 is below the median of 364 across 27 observational studies indexed under Embolic Stroke.
Browse Embolic Stroke studies →Instituto de Investigación Hospital Universitario La Paz is the lead sponsor of 104 studies on the registry; 14 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with acute ischemic stroke, with a major cardioembolic source and previosly treated with oral or parental anticoagulants.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with acute ischemic stroke of cardioembolic source and previosly anticoagulated in which anticoagulant therapy is mantained
Other: Observation
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
Ischemic stroke recurrence
recurrence of ischemic stroke noticied by changes in neurologic status and supported by neuroimaging
Time frame: 90 days
Symptomatic haemorrhagic transformation
Symptomatic haemorrhagic transformation defined by the SITS criteria and supported by neuroimaging
Time frame: 90 days
Early ischemic stroke recurrence
Recurrence of ischemic stroke at days 1 or day 7
Time frame: Day 1 or day 7
Early symptomatic haemorrhagic transformation
Symptomatic transformation ocurring on day 1 or day 7
Time frame: 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
Time frame: Day 1 or day 7
Systemic embolism
Clinical, radiologic or analytic findings that suggest an ischemic event (myocardic, renal, splenic, bowl or limb infarctions
Time frame: 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
Time frame: Day 1, day 7 or day 90
Mortality
Death
Time frame: Day 7
Neurologic status
NIHSS scale
Time frame: Day 90
Functional status
modified Rankin scale
Time frame: Day 90
Plan to share: Undecided
No publications or documents are linked to this record.
Started Mar 2021 (actual). Primary completion is estimated for Dec 2023, 33 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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