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

No results posted yet for this study

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04851457 on ClinicalTrials.gov