Status:
COMPLETED
One Pass Tirofiban In Management of Ischemic Stroke Thrombectomy In China
Lead Sponsor:
Shanghai East Hospital
Collaborating Sponsors:
Shanghai 6th People's Hospital
Ningbo No. 1 Hospital
Conditions:
Ischemic Stroke
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
Brief 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 thro...
Detailed Description
This study is a multicenter, prospective, open-label, randomized controlled, blinded-endpoint trial with two parallel groups and a 3-month follow-up. A total of 200 eligible participants recruited fro...
Eligibility Criteria
Inclusion
- Age 18-85 years (including 18 and 85);
- Acute ischemic stroke within 24 hours of onset, and NIHSS \>5 points;
- Acute large vessel occlusion, including internal carotid artery, M1 segment of middle cerebral artery, M2 segment of middle cerebral artery;
- Multimodal CT/MRI imaging was completed before thrombectomy, and the following criteria were met: penumbra\>10ml, infarct core volume \<70ml, and mismatch rate \>1.2;
- Planned to receive endovascular treatment;
- Informed consent was obtained.
Exclusion
- History of atrial fibrillation or atrial flutter, or 12-lead ECG before randomization and after admission showing atrial flutter or atrial fibrillation;
- Treated with intravenous thrombolysis for this stroke or currently taking new oral anticoagulant drugs, warfarin, ticagrelor and other drugs that may increase the risk of bleeding;
- Pre-stroke disability (pre-stroke mRS score \> 2);
- Severe comorbidity (such as severe cardiopulmonary dysfunction, or the terminal stage of malignant tumors with expected survival less than 90 days);
- CT shows hypodensity lesions in more than 1/3 of the territory of the middle cerebral artery;
- Allergy to tirofiban or having any contraindications to the use of tirofiban (patients with active internal bleeding, history of intracranial hemorrhage, intracranial tumors, arteriovenous malformations, and intracranial aneurysms, or patients resulting in thrombocytopenia from the use of tirofiban previously);
- Contraindications to the contrast agents used in multimodal CT/MRI examination (such as allergy to the contrast agents, etc.);
- Pregnant or breastfeeding women;
- Patients currently participating in other clinical study trials;
- Other conditions determined by the investigator are not suitable for inclusion in this study.
Key Trial Info
Start Date :
April 6 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 15 2023
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04851457
Start Date
April 6 2021
End Date
October 15 2023
Last Update
January 9 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Gang Li
Shanghai, Shanghai Municipality, China, 200123