Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06352619
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-09
First Post:
2024-04-02
Brief Title:
Third Enhanced Control of Hypertension and Thrombectomy Stroke Domain Within ACT-GLOBAL Adaptive Platform Trial
Sponsor:
The George Institute
Organization:
The George Institute
Study Overview
Official Title:
Third Enhanced Control of Hypertension and Thrombectomy Stroke Domain Within A Multi-faCtorial mulTi-arm Multi-staGe Randomised gLOBal Adaptive pLatform Trial for Stroke ACT-GLOBAL_ENCHANTED3MT
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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:
ENCHANTED3MT
Brief Summary:
Several clinical trials have produced variable conclusions regarding the effects of intensive blood pressure BP lowering in post-EVT acute ischaemic stroke AIS patients Although two trials indicate harm from very intensive target-based treatment SBP 130 mmHg the others neutral effects in the SBP range 140-160 mmHg The ENCHANTED3MT domain of the ACT-GLOBAL platform trial aims to test different approaches to the treatment of elevated SBP in post-EVT AIS patients to find an optimal BP management strategy ENCHANTED3MT will randomize 111 up to 2000 patients with SBP 150 mmHg post-EVT to conservative no or minimal SBP reduction by 5-10mmHg or a target of 175-180mmHg if very-high baseline SBP 180mmHg moderate SBP reduction by 10-20mmHg or a target of 160 5 whichever is higher no control if low-high baseline SBP 150-160mmHg or intensive SBP reduction by 30-50mmHg or a target of 1405 mmHg whichever is higher BP management
Detailed Description:
ACT-GLOBAL is an international multi-factorial multi-arm multi-stage randomized adaptive platform trial designed to simultaneously evaluate multiple treatments that may improve outcomes in stroke One domain is ENCHANTED3MT aiming to compare three BP lowering management strategies in post-EVT AIS patients with elevated SBP determine the best approach to improve functional outcome
Background and Rationale - Different reperfusion status may have different BP patterns A U-shaped correlation between post-EVT BP and outcomes may exist for patients who underwent recanalisation post-EVT In addition different BP lowering strategy may have different safety profiles and may potentially impact differently with regards to the risk of ICH for patients with reperfusion therapy
The controversial overall clinical effect seen in clinical trials including ENCHANTED2MT OPTIMAL BP BP TARGET BEST II and ENCHANTED does not resolve the question over the optimal BP control strategy following EVT The evidence is insufficient to make sensible recommendations over the optimal BP management in this important clinical group Thus the Blood Pressure Domain ENCHANTED3MT aims to test different treatment approaches to the control of elevated SBP post-EVT in AIS patients to find the optimal BP management that leads to improved functional status with reduced ICH and no other harms
ENCHANTED3MT will randomize 111 up to 2000 patients with SBP 150 mmHg post-EVT to the following three BP lowering management strategies
Primary outcome is modified Rankin scale mRS at 90 days analysed with utility-weighted mRS using a Bayesian hierarchical linear model Adaptive analyses will be conducted 3-monthly with prespecified statistical triggers for superiority inferiority and equivalence
Background and Rationale - Different reperfusion status may have different BP patterns A U-shaped correlation between post-EVT BP and outcomes may exist for patients who underwent recanalisation post-EVT In addition different BP lowering strategy may have different safety profiles and may potentially impact differently with regards to the risk of ICH for patients with reperfusion therapy
The controversial overall clinical effect seen in clinical trials including ENCHANTED2MT OPTIMAL BP BP TARGET BEST II and ENCHANTED does not resolve the question over the optimal BP control strategy following EVT The evidence is insufficient to make sensible recommendations over the optimal BP management in this important clinical group Thus the Blood Pressure Domain ENCHANTED3MT aims to test different treatment approaches to the control of elevated SBP post-EVT in AIS patients to find the optimal BP management that leads to improved functional status with reduced ICH and no other harms
ENCHANTED3MT will randomize 111 up to 2000 patients with SBP 150 mmHg post-EVT to the following three BP lowering management strategies
Primary outcome is modified Rankin scale mRS at 90 days analysed with utility-weighted mRS using a Bayesian hierarchical linear model Adaptive analyses will be conducted 3-monthly with prespecified statistical triggers for superiority inferiority and equivalence
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