One Pass Tirofiban In Management of Ischemic Stroke Thrombectomy In China
NCT04851457 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200
Last updated 2024-01-09
Summary
In recent years, the positive results of trials for mechanical thrombectomy (MT) have brought a new era for large artery occlusion patients, especially those beyond the time window of intravenous thrombolysis. However, interventional procedures can cause endothelial injuries leading to local activation of platelet aggregation and subsequent thromboembolic complications or early re-occlusion.Tirofiban is a specific antagonist of the platelet glycoprotein (GP) IIb/IIIa receptor, which is considered highly effective against the final common pathway of platelet aggregation and preventing vascular reocclusion. However, there is no consensus on if AIS patients treated with MT also benefit from intravenous tirofiban. This study aims to evaluate the effectiveness and safety of profiles of tirofiban during MT and provide reliable clinical evidence for the treatment of tirofiban in AIS patients.
Conditions
Interventions
- DRUG
-
Intravenous tirofiban combination therapy
Patients will enter the tirofiban treatment protocol immediately within half an hour after randomization and prior to the femoral artery puncture. Tirofiban is administered as an intravenous bolus dose of 10 μg/kg injection within 3 min and then by an intravenous infusion at a rate of 0.1 μg/(kg·min) for 24 hours.
Sponsors & Collaborators
-
Shanghai 6th People's Hospital
collaborator OTHER -
Ningbo No. 1 Hospital
collaborator OTHER -
Zhangzhou Municipal Hospital of Fujian Province
collaborator OTHER -
Shanghai 7th People's Hospital
collaborator OTHER -
Jinan Central Hospital
collaborator OTHER -
Xuchang Central Hospital
collaborator UNKNOWN -
Shanghai East Hospital
lead OTHER
Principal Investigators
-
Gang Li · Shanghai East Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-04-06
- Primary Completion
- 2023-07-08
- Completion
- 2023-10-15
Countries
- China
Study Locations
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