Beijing Anzhen Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, 101118, China
Location status: Recruiting
NCT Number: NCT07026318
This randomized controlled trial aims to evaluate whether adjunctive tirofiban therapy combined with endovascular treatment (EVT) improves neurological outcomes in patients with acute large vessel occlusion due to large-artery atherosclerosis. Patients will be randomized to receive either tirofiban or matching placebo after EVT. The primary efficacy endpoint is the proportion of patients achieving functional independence (modified Rankin Scale 0-2) at 90±7 days, while the safety endpoint is the probability of symptomatic intracranial hemorrhagewithin 48 hours after randomization.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Beijing, Beijing Municipality, 101118, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
After endovascular treatment, tirofiban is infused at a rate of 0.4 μg/kg/min for 30 minutes, followed by a maintenance infusion at 0.1 μg/kg/min until 24 hours postoperatively.
Following endovascular treatment, patients receive normal saline placebo, with the dosage calculated in the same manner as that of tirofiban in the experimental group.
Time frame: 90±7 days
Proportion of patients with Modified Rankin Scale (mRS) 0-2, Modified Rankin Scale(0-6), A lower MRS score indicates better functional status for the patient.
Time frame: 36±12 hours post-randomization
Change in National Institute of Health stroke scale score from baseline.The NIH Stroke Scale (NIHSS) score ranges from 0 to 42 points, with lower scores indicating better neurological function
Time frame: 36±12 hours post-randomization
Vascular recanalization rate assessed by CT/MR angiography
Time frame: 7±3 days post-randomization or discharge
Change in infarct volume
Time frame: 7±3 days/discharge;90±7 days post-randomization
Modified Rankin Scale(0-6), A lower MRS score indicates better functional status for the patient.
Time frame: 90±7 days
Proportion of patients achieving mRS 0-1
Time frame: 90±7 days
Proportion of patients achieving mRS 0-3
Time frame: 90±7 days
Incidence of Pharmacologic rescue therapy
Time frame: 90±7 days
Incidence of rescue therapy
Time frame: 90±7 days
The EuroQol 5-Dimension 5-Level Utility Score (EQ-5D-5L utility score) ranges from -0.594 to 1.000 (Chinese value set), assessing health-related quality of life, with higher scores indicating better health status.
Time frame: 48 hours
Probability of symptomatic intracranial hemorrhage (Heidelberg Standards)
Time frame: 90±7 days post-randomization
All-cause mortality
Time frame: 48 hours post-randomization
Probability of any intracranial hemorrhage (Heidelberg Standards)
Contact information is provided by the study sponsor or research team.
Xiaochuan Huo, Doctor
CONTACT
Xin Tong, Doctor
CONTACT
Beijing Anzhen Hospital
Other
Endovascular Therapy Combined With Tirofiban for Intracranial Atherosclerotic Acute Ischemic Stroke: A Multicenter, Prospective, Double-blind, Vehicle-controlled, Randomized Controlled Trial
Acronym: ANGEL-DRUG
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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