Safety and Efficacy of Adjunct Tirofiban Treatment After Successful Mechanical Thrombectomy Recanalization in Acute Anterior Circulation Ischemic Stroke- A Multicenter, Prospective, Double-blind, Randomized Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY

Acute ischemic stroke with large vessel occlusion is a frequently occurring life-threatening condition. Although endovascular treatment can effectively open occluded vessels, the successful reperfusion rate exceeds 80%, but the rate of good prognosis is less than 50%. The current clinical focus is on how to improve futile recanalization. Tirofiban is widely used in the treatment of stroke, as it can effectively prevent vascular reocclusion and improve microcirculation perfusion. It has the potential to improve futile recanalization, but there is a lack of high-level evidence-based medical support. This multicenter, prospective, double-blind, randomized controlled trial was conducted to assess the effectiveness and safety of sequential tirofiban therapy following successful mechanical thrombectomy within 24 hours of onset.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥18 years old;

• NIHSS score: 6-30;

• Symptom onset to random time of 24h, including wake-up stroke or unwitnessed stroke; The onset time of symptoms was defined as the last time of normal performance.

• mRS 0-1 before the stroke;

• Subject or legal representative can sign an informed consent form;

• Clinical symptoms caused by acute occlusion of the following sites confirmed by CTA or MRA: intracranial segment of ICA, M1 segment of middle cerebral artery, M2 trunk of middle cerebral artery;

• ASPECTS≥6 on NCCT or DWI;

• After the end of mechanical thrombectomy, the mTICI was stable at 2b/3, and there was no secondary embolism in other non-offending vessels, or the diagnostic angiography before mechanical thrombectomy showed that the occluded vessels improved to mTICI 2b/3, and no mechanical thrombectomy was planned.

Locations
Other Locations
China
Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology
RECRUITING
Wuhan
Contact Information
Primary
Xiang Luo
flydottjh@163.com
13349893413
Time Frame
Start Date: 2024-04-09
Estimated Completion Date: 2026-01-01
Participants
Target number of participants: 1360
Treatments
Experimental: Tirofiban group
After the completion of endovascular treatment and successful recanalization (mTICI 2b/3), the patients were randomly assigned to the experimental group. Tirofiban 5μg/kg was administered intravenously through the catheter artery at a rate of 1ml/min, followed by an intravenous infusion of 0.1μg/(kg·min) for 24 hours. Standard medical treatment was administered after the surgery.
Placebo_comparator: placebo group
After the completion of endovascular treatment and successful recanalization (mTICI 2b/3), the patients were randomly assigned to the control group. Saline placebo was administered in the same manner as tirofiban group. Standard medical treatment was administered after the surgery.
Related Therapeutic Areas
Sponsors
Collaborators: Xianning Central Hospital, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, The First Affiliated Hospital of Yangtze University, Jingzhou Central Hospital, The Central Hospital of Enshi Tujia And Miao Autonomous Prefecture, Xiangyang No.1 People's Hospital, Wuhan Central Hospital, Affiliated Hospital of Chengde Medical University, Beijing Tiantan Hospital, Wuhan Third Hospital, Huangshi Central Hospital, The First Affiliated Hospital of Zhengzhou University, The Fifth Hospital of Wuhan, Wuhan Puren Hospital, Wuhan Hospital of Traditional Chinese Medicine, Renmin Hospital of Wuhan University, Zhongnan Hospital, Hanyang University, Taihe Hospital, Second Affiliated Hospital of Soochow University, Yichang Central People's Hospital, Nanyang Central Hospital
Leads: Xiang Luo

This content was sourced from clinicaltrials.gov