Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06556446
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-06-24
Brief Title:
Intravenous Thrombolysis in Patients With Ischemic Stroke and Recent Ingestion of Direct Oral Anticoagulants
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Safety and Efficacy of Intravenous Thrombolysis in Patients With Ischemic Stroke and Recent Ingestion of Direct Oral Anticoagulants the DOAC - International Thrombolysis DO-IT Cohort Study
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DO-IT Cohort
Brief Summary:
DO-IT is an international prospective observational registry evaluating whether the administration of intravenous thrombolysis IVT is safe and improves functional outcome in ischemic stroke patients with recent direct oral anticoagulant DOAC intake For this purpose information on 2800 adult participants experiencing an acute ischemic stroke will be obtained at several high-volume international stroke centers and divided into three groups IVT with recent DOACs intake DOACIVT and recent DOAC intake not receiving IVT DOAC as well as anonymized patients without DOAC receiving IVT The patients are followed up for 90 days after the index event treatment recommendations from the described observations The investigators hypothesize that also more liberal decisions for IVT in patients with recent DOAC intake are not associated with an increased risk for symptomatic intracerebral hemorrhage sICH and result in better functional outcome at 3 month
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None