Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06383741
Status:
RECRUITING
Last Update Posted:
2024-04-25
First Post:
2024-01-08
Brief Title:
Predicting Outcomes in ICH Patients on Direct Factor Xa Inhibitors
Sponsor:
Insel Gruppe AG University Hospital Bern
Organization:
Insel Gruppe AG University Hospital Bern
Study Overview
Official Title:
Forecast of Functional Outcome and Impact of Anti Factor Xa-levels in Patients With Intracerebral Haemorrhage Related to Direct Factor Xa Inhibitors - a Multi-center Cohort Study
Status:
RECRUITING
Status Verified Date:
2024-04
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:
FIRE-Xa
Brief Summary:
This study focuses on direct factor Xa inhibitors apixaban edoxaban rivaroxaban and the thrombin inhibitor dabigatran commonly used for stroke prevention in atrial fibrillation Despite lower intracranial bleeding risks with these drugs around 02-10 of patients annually experience intracranial hemorrhage ICH predominantly intracerebral
Treatment options for factor-Xa inhibitor-associated ICH such as prothrombin complex concentrate PCC and andexanet alfa lack direct comparison evidence except for ongoing trials like ANNEXA-I This trial assesses hemostatic efficacy and 30-day functional outcomes but leaves gaps regarding anticoagulant activitys role and long-term effects especially in patients presenting late after drug intake
The measurement of anti-FXa levels helps guide decisions yet their link to hematoma expansion remains unknown Efforts to streamline measurement within 30 minutes for acute decisions have shown variability in levels with some patients exhibiting high levels even beyond 12 hours post-intake This lack of data poses challenges particularly for patients potentially benefiting from treatment beyond the current strict time window
Early hematoma expansion strongly predicts poor outcomes but preventing it faces challenges like recurrent events up to 5 by 3 months and rehabilitation intensity potentially negating its benefits The ANNEXA-I trial evaluates short-term outcomes highlighting the need for additional data to comprehend long-term ICH prognosis
The studys objectives involve linking hematoma expansion to anti-FXa levels determining late-presenting patients risk of expansion and identifying predictors of favorable outcomes at 3 6 and 12 months Primary endpoints include functional outcomes while secondary ones encompass expansion rates anticoagulant activity and various events at 12 months
This research aims to bridge gaps in understanding factor-Xa inhibitor-related ICH addressing both immediate and prolonged outcomes to enhance clinical decision-making
Treatment options for factor-Xa inhibitor-associated ICH such as prothrombin complex concentrate PCC and andexanet alfa lack direct comparison evidence except for ongoing trials like ANNEXA-I This trial assesses hemostatic efficacy and 30-day functional outcomes but leaves gaps regarding anticoagulant activitys role and long-term effects especially in patients presenting late after drug intake
The measurement of anti-FXa levels helps guide decisions yet their link to hematoma expansion remains unknown Efforts to streamline measurement within 30 minutes for acute decisions have shown variability in levels with some patients exhibiting high levels even beyond 12 hours post-intake This lack of data poses challenges particularly for patients potentially benefiting from treatment beyond the current strict time window
Early hematoma expansion strongly predicts poor outcomes but preventing it faces challenges like recurrent events up to 5 by 3 months and rehabilitation intensity potentially negating its benefits The ANNEXA-I trial evaluates short-term outcomes highlighting the need for additional data to comprehend long-term ICH prognosis
The studys objectives involve linking hematoma expansion to anti-FXa levels determining late-presenting patients risk of expansion and identifying predictors of favorable outcomes at 3 6 and 12 months Primary endpoints include functional outcomes while secondary ones encompass expansion rates anticoagulant activity and various events at 12 months
This research aims to bridge gaps in understanding factor-Xa inhibitor-related ICH addressing both immediate and prolonged outcomes to enhance clinical decision-making
Detailed Description:
The utilization of direct oral anticoagulants DOACs such as factor Xa inhibitors apixaban edoxaban rivaroxaban and the thrombin inhibitor dabigatran has emerged as a pivotal strategy for preventing stroke in patients with atrial fibrillation and thromboembolic diseases While the risk of intracranial bleeding is notably lower by about 50 with DOACs in comparison to Vitamin K antagonists a fraction of patients 02-10 annually still experiences intracranial hemorrhages primarily intracerebral Notably based on data from the Swiss Stroke Registry spanning 2014 to 2019 91 of patients admitted to stroke units or centers for intracerebral hemorrhage ICH had prior DOAC therapy This incidence continues to rise with 95 of DOAC-associated intracerebral hemorrhages occurring during factor Xa inhibitor therapy
Treatment strategies for factor Xa inhibitor-associated intracerebral hemorrhage encompass prothrombin complex concentrate PCC and the specific reversal agent andexanet alfa However the available evidence relies on observational cohort studies and independent patient samples lacking direct comparative trials The ongoing randomized controlled trial ANNEXA-I aims to assess the efficacy of andexanet alfa compared to standard care The primary outcome includes hemostatic efficacy measured by imaging within a 12-hour window and functional outcomes evaluated at 30 days While ANNEXA-I anticipates providing valuable insights into factor Xa-associated intracerebral hemorrhage treatment significant aspects concerning the role of anticoagulant activity particularly in patients presenting late after their last dosage intake and long-term outcomes will remain unanswered
Assessing anticoagulant activity through anti-FXa levels remains integral yet inconclusive regarding its correlation with hematoma expansion risk Despite streamlined anti-FXa level measurements at the investigators institution heterogeneity in these levels persists including elevated levels 100ngml observed even beyond 12 hours post-intake Notably the inclusion criteria for ANNEXA-I predominantly consider the time since the last intake 15 hours of factor Xa inhibitors often omitting anti-FXa level measurements This oversight might exclude a subgroup of patients who could potentially benefit from andexanet alfa treatment beyond the current strict time window
Early hematoma expansion significantly impacts outcomes however challenges such as recurrent events and rehabilitation intensity may dilute the benefits of preventing hematoma expansion ANNEXA-I primarily focuses on short-term outcomes necessitating additional data to comprehend long-term prognoses post intracerebral hemorrhage
This research aims to establish associations between hematoma expansion and anti-FXa levels identify risks in late-presenting patients and predict favorable outcomes at 3 6 and 12 months Primary endpoints include functional outcomes while secondary endpoints involve expansion rates anticoagulant activity and various events at the 12-month mark The comprehensive analysis seeks to bridge gaps in understanding intracerebral hemorrhages associated with DOACs guiding clinical decisions for both immediate and extended prognoses
Treatment strategies for factor Xa inhibitor-associated intracerebral hemorrhage encompass prothrombin complex concentrate PCC and the specific reversal agent andexanet alfa However the available evidence relies on observational cohort studies and independent patient samples lacking direct comparative trials The ongoing randomized controlled trial ANNEXA-I aims to assess the efficacy of andexanet alfa compared to standard care The primary outcome includes hemostatic efficacy measured by imaging within a 12-hour window and functional outcomes evaluated at 30 days While ANNEXA-I anticipates providing valuable insights into factor Xa-associated intracerebral hemorrhage treatment significant aspects concerning the role of anticoagulant activity particularly in patients presenting late after their last dosage intake and long-term outcomes will remain unanswered
Assessing anticoagulant activity through anti-FXa levels remains integral yet inconclusive regarding its correlation with hematoma expansion risk Despite streamlined anti-FXa level measurements at the investigators institution heterogeneity in these levels persists including elevated levels 100ngml observed even beyond 12 hours post-intake Notably the inclusion criteria for ANNEXA-I predominantly consider the time since the last intake 15 hours of factor Xa inhibitors often omitting anti-FXa level measurements This oversight might exclude a subgroup of patients who could potentially benefit from andexanet alfa treatment beyond the current strict time window
Early hematoma expansion significantly impacts outcomes however challenges such as recurrent events and rehabilitation intensity may dilute the benefits of preventing hematoma expansion ANNEXA-I primarily focuses on short-term outcomes necessitating additional data to comprehend long-term prognoses post intracerebral hemorrhage
This research aims to establish associations between hematoma expansion and anti-FXa levels identify risks in late-presenting patients and predict favorable outcomes at 3 6 and 12 months Primary endpoints include functional outcomes while secondary endpoints involve expansion rates anticoagulant activity and various events at the 12-month mark The comprehensive analysis seeks to bridge gaps in understanding intracerebral hemorrhages associated with DOACs guiding clinical decisions for both immediate and extended prognoses
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?:
None
Is an FDA AA801 Violation?:
None