In patients with acute ischemic stroke secondary to large vessel occlusion, the role of intravenous adjunctive medications, such as tirofiban, or thrombolysis before endovascular thrombectomy has not been well investigated. This trial aim to evaluate the efficacy and safety of intravenous tirofiban versus thrombolysis for acute ischemic stroke patients with large vessel occlusion piror to endovascular thrombectomy.
Intravenous thrombolysis bridging with endovascular treatment (EVT) has been proven to be effective therapy in acute ischemic stroke patients due to large vessel occlusion (LVO). Several randomized controlled trials, aiming to explore the benefits and risks of intravenous thrombolysis prior to EVT in LVO stroke, have suggested that intravenous thrombolysis should not be omitted. Although intravenous thrombolysis results in successful reperfusion in approximately 10% to 20% of LVO patients, obviating the need for EVT, it has limitations. First, the time window for intravenous thrombolysis is narrow with strict indications and contraindications. Second, it may increase the risk of intracranial hemorrhage. Furthermore, thrombolysis is expensive. The above limitations lead to a very low proportion of patients who receive intravenous thrombolysis. Tirofiban is a selective IIb/IIIa receptor inhibitor, and it's effective in preventing thrombosis complications. Intravenous tirofiban has been increasingly used as an adjunctive treatment in acute ischemic stroke patients receiving EVT. However, a direct comparison between tirofiban and thrombolysis in LVO stroke has not been performed. We therefore conduct a randomized controlled trials to evaluate the efficacy and safety of intravenous tirofiban versus thrombolysis prior to EVT for acute ischemic stroke patients with LVO.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1,014
Intravenous tirofiban before endovascular thrombectomy.
Intravenous thrombolysis before endovascular thrombectomy.
Functional independence
modified Rankin scale score of 0 to 2. (The modified Rankin scale scores range from 0 to 6, with 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death)
Time frame: 90 days post-endovascular treatment
Modified Rankin scale score at 90 days
Time frame: 90 days post-endovascular treatment
Excellent outcome
Modified Rankin Scale score 0 to 1, or Modified Rankin scale score return to baseline
Time frame: 90 days post-endovascular treatment
Successful reperfusion before thrombectomy
The expanded Thrombolysis In Cerebral Infarction (eTICI) reperfusion grading system is a 6-point scale: 0 indicates no reperfusion noted; 1, reduction in thrombus without filling of distal arterial branches; 2a, reperfusion of \<50% of the territory; 2b, a reperfusion of ≥50% of the territory; 2c, near-complete perfusion with distal slow flow or presence of small cortical emboli; and 3, complete reperfusion. Successful reperfusion at initial angiogram prior to thrombectomy was defined as an eTICI grade of 2b, 2c, or 3 on the first intracranial angiogram.
Time frame: Prior to thrombectomy
Successful reperfusion on the final angiogram
Achieve eTICI 2b, 2c or 3
Time frame: End-of-procedure angiography
First pass excellent reperfusion
Achieve eTICI 2c or 3
Time frame: After the first thrombectomy pass
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Taihe County People's Hospital
Fuyang, Anhui, China
Yijishan Hospital of Wannan Medical University
Wuhu, Anhui, China
Longyan First Hospital of Fujian Medical University
Longyan, Fujian, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Quanzhou County People's Hospital
Quanzhou, Guangxi, China
The First Affiliated Hospital of Hainan Medical University
Haikou, Hainan, China
The First Affiliated Hospital of Henan Polytechnic University (Jiaozuo Second People's Hospital)
Jiaozuo, Henan, China
Shenqiu County People's Hospital
Shenqiu, Henan, China
Xihua People's Hospital
Wacheng Neighborhood, Henan, China
The First Affiliated Hospital, Hengyang Medical School, University of South China
Hengyang, Hunan, China
...and 32 more locations
First pass successful reperfusion
Achieve eTICI 2b, 2c or 3
Time frame: After the first thrombectomy pass
Time from puncture to reperfusion or procedure completion
Time frame: from puncture to reperfusion or procedure completion
Use of balloon angioplasty or stenting during procedure
Time frame: During endovascular treatment
National Institutes of Health Stroke Scale score at 5 to 7 days or discharge if earlier
Scores on National Institutes of Health Stroke Scale (NIHSS) range from 0 to 42, with less scores indicating less severe neurologic deficits.
Time frame: At 5 to 7 days post-endovascular treatment or discharge if earlier
EQ-5D-5L scale score at 90 days
Scores on the European Quality Five-Dimension Five-Level Self-Report Questionnaire (EQ-5D-5L) range from -0.39 to 1, with higher scores indicating a better quality of life; 0 is the value of a health state equivalent to death.
Time frame: 90 days post-endovascular treatment