Ignite Creation Date:
2024-05-06 @ 8:05 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06241677
Status:
RECRUITING
Last Update Posted:
2024-02-23
First Post:
2024-01-17
Brief Title:
Intravenous Thrombolytic Therapy in Acute Ischemic Stroke Patients on DOAC
Sponsor:
Chinese University of Hong Kong
Organization:
Chinese University of Hong Kong
Study Overview
Official Title:
Intravenous Thrombolytic Therapy in Acute Ischemic Stroke Patients on Direct Oral Anticoagulants - a Prospective Multicenter Study
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DOAC-IVT
Brief Summary:
Direct oral anticoagulants DOAC have emerged as safe and efficacious ischemic stroke prophylaxis for non-valvular atrial fibrillation NVAF All four DOACs - apixaban dabigatran edoxaban rivaroxaban - were associated with lower risks of major bleeding compared to warfarin Listed as core essential medicines by the World Health Organization DOAC prescriptions have been surging worldwide In Hong Kong approximately 80000 patients received DOACs from January 2009 through December 2022 according to the Hospital Authority registry
The widespread DOAC usage had created DOAC-specific clinical dilemmas that lack evidence-based treatment despite twenty years of prescribing experience Ischemic stroke despite DOAC IS-DOAC in particular may occur in up to 6 of DOAC users annually Due to the in vivo anticoagulation effect there had been concerns of intracerebral bleeding ICH with intravenous thrombolytic therapy IVT for acute IS-DOAC Under the current guideline recommendations most acute IS-DOAC are contraindicated to IVT see Intravenous thrombolytic therapy which resulted in only a small proportion of acute ISDOAC patients being able to receive IVT even if presented early Nonetheless our group found that majority of patients had a DOAC level of 50ngmL only 24 hours after DOAC cessation see work done by us a level deemed clinically negligible and safe for thrombolytic therapy Together with evolving clinical evidence discussed below IS-DOAC patients maybe unnecessarily barred from IVT thus compromised functional recovery
With robust pharmacokinetic and retrospective clinical evidence to support it is hypothesized that IVT are safe in IS-DOAC patient The investigators hereby propose a prospective multicenter study to determine the efficacy and safety of IVT in acute IS-DOAC
The widespread DOAC usage had created DOAC-specific clinical dilemmas that lack evidence-based treatment despite twenty years of prescribing experience Ischemic stroke despite DOAC IS-DOAC in particular may occur in up to 6 of DOAC users annually Due to the in vivo anticoagulation effect there had been concerns of intracerebral bleeding ICH with intravenous thrombolytic therapy IVT for acute IS-DOAC Under the current guideline recommendations most acute IS-DOAC are contraindicated to IVT see Intravenous thrombolytic therapy which resulted in only a small proportion of acute ISDOAC patients being able to receive IVT even if presented early Nonetheless our group found that majority of patients had a DOAC level of 50ngmL only 24 hours after DOAC cessation see work done by us a level deemed clinically negligible and safe for thrombolytic therapy Together with evolving clinical evidence discussed below IS-DOAC patients maybe unnecessarily barred from IVT thus compromised functional recovery
With robust pharmacokinetic and retrospective clinical evidence to support it is hypothesized that IVT are safe in IS-DOAC patient The investigators hereby propose a prospective multicenter study to determine the efficacy and safety of IVT in acute IS-DOAC
Detailed Description:
In this prospective cohort study the investigators aim to recruit consecutive DOAC users with IS-DOAC who meet the inclusion criteria The investigators aim to determine the safety and efficacy of IVT among DOAC patients with acute ischemic stroke It is hypothesized that compared to a matched cohort of patients with acute IS-DOAC excluded from IVT IVT in IS-DOAC patients with a last-DOAC-ingestion of 12-48 hours improves neurological outcomes with an acceptable safety profile
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None