Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2025-12-31 @ 11:31 AM
Study NCT ID:
NCT07091994
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-29
First Post:
2025-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Prospective, Multicentre, Randomized Controlled Trial of Edaravone Dexborneol in Acute Ischemic Stroke With Active Malignancy
Sponsor:
Nanfang Hospital, Southern Medical University
Organization:
Study Overview
Official Title:
A Prospective, Multicentre, Randomized Controlled Trial of Edaravone Dexborneol in Acute Ischemic Stroke With Active Malignancy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-07
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:
PRECISE AM
Brief Summary:
This multicenter randomized controlled trial aims to evaluate the efficacy and safety of edaravone dexborneol injection in patients with acute ischemic stroke (AIS) complicated by active malignancies. The study will primarily investigate whether this combined antioxidant and anti-inflammatory treatment can improve neurological functional recovery and assess its safety profile in this high-risk population. Researchers will compare outcomes between the edaravone dexborneol treatment group and a control group receiving standard therapy to determine if the intervention provides superior neuroprotective effects. Participants will receive the assigned treatment regimen, undergo serial neurological assessments and imaging studies to monitor stroke progression and recovery, and be closely followed for safety evaluations. The findings may offer evidence-based therapeutic options for managing this challenging clinical scenario where current treatment alternatives are limited.
Detailed Description:
Patients with acute ischemic stroke (AIS) who also have active malignancies face a more complex clinical scenario, with limited treatment options and generally poor prognoses. The coexistence of these two conditions can interact through inflammatory and oxidative stress pathways, forming a vicious cycle that exacerbates the patient's condition. Edaravone dexborneol injection exhibits significant antioxidant and anti-inflammatory effects, effectively scavenging free radicals in the body, thereby potentially improving the outcomes of AIS patients. Our team's preliminary retrospective study demonstrated that edaravone dexborneol injection can promote neurological recovery in AIS patients with active malignancies and shows a favorable safety profile. Therefore, this study aims to conduct a multicenter randomized controlled trial to evaluate the efficacy and safety of edaravone dexborneol injection in treating AIS patients with active malignancies, with the goal of providing evidence-based medical support and more effective therapeutic strategies for this specific patient population.
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?: