Hangzhou First People's Hospital
Hangzhou, Zhejiang, 310000, China
Location status: Recruiting
NCT Number: NCT05728333
In patients with acute ischemic stroke secondary to large vessel occlusion, the role of intravenous adjunctive medications, such as tirofiban, or alteplase before endovascular thrombectomy has not been well investigated. This trial aim to evaluate the efficacy and safety of intravenous tirofiban versus alteplase for acute ischemic stroke patients with large vessel occlusion piror to endovascular thrombectomy.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 2 / Phase 3
Hangzhou, Zhejiang, 310000, China
Location status: Recruiting
Intravenous alteplase 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 alteplase prior to EVT in LVO stroke, have suggested that intravenous alteplase should not be omitted. Although intravenous alteplase 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 alteplase is narrow with strict indications and contraindications. Second, it may increase the risk of intracranial hemorrhage. Furthermore, alteplase 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 alteplase in LVO stroke has not been performed. We therefore conduct a randomized controlled trials to evaluate the efficacy and safety of intravenous tirofiban versus alteplase prior to EVT for acute ischemic stroke patients with LVO.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Intravenous tirofiban before endovascular thrombectomy.
Other names: Tirofiban & EVT
Intravenous alteplase before endovascular thrombectomy.
Other names: Alteplase & EVT
Time frame: 90 days post-endovascular treatment
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)
Contact information is provided by the study sponsor or research team.
Hongfei Sang, Doctor
CONTACT
Zhongming Qiu, Doctor
CONTACT
Xinqiao Hospital of Chongqing
Other
Intravenous Adjuvant With Tirofiban Versus Alteplase Before Mechanical Thrombectomy in Acute Ischemic Stroke Patients With Large Vessel Occlusion: a Multicenter, Open Label, Randomized Controlled Trial.
Acronym: ADJUVANT
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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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