One Pass Tirofiban In Management of Ischemic Stroke Thrombectomy In China (OPTIMISTIC)

January 7, 2024 updated by: Shanghai East Hospital

Safety and Efficacy of Tirofiban in Acute Ischemic Stroke Patients Treated With Mechanical Thrombectomy-A Prospective, Randomized, Controlled, Open-Label, Assessor-Blind, Multicenter Clinical Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 from 4-6 stroke centers will be randomly allocated to either an experimental group (intravenous tirofiban + MT therapy) or a control group (MT alone) in a 1:1 ratio. The primary outcome is a composite endpoint, including the rate of recanalisation after the first embolectomy and the risk of symptomatic intracerebral haemorrhage. The secondary outcomes include clinical and neuroimaging outcomes, procedure-related complications, and adverse events to evaluate the effects of MT in combination with tirofiban treatment compared to MT alone in AIS patients. Intention-to-treat (ITT) analysis will be undertaken in this study, and the full analysis set (FAS) population serves as the primary population for the analysis of efficacy data.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200123
        • Gang Li

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age 18-85 years (including 18 and 85);
  2. Acute ischemic stroke within 24 hours of onset, and NIHSS >5 points;
  3. Acute large vessel occlusion, including internal carotid artery, M1 segment of middle cerebral artery, M2 segment of middle cerebral artery;
  4. 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;
  5. Planned to receive endovascular treatment;
  6. Informed consent was obtained.

Exclusion Criteria:

  1. History of atrial fibrillation or atrial flutter, or 12-lead ECG before randomization and after admission showing atrial flutter or atrial fibrillation;
  2. 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;
  3. Pre-stroke disability (pre-stroke mRS score > 2);
  4. Severe comorbidity (such as severe cardiopulmonary dysfunction, or the terminal stage of malignant tumors with expected survival less than 90 days);
  5. CT shows hypodensity lesions in more than 1/3 of the territory of the middle cerebral artery;
  6. 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);
  7. Contraindications to the contrast agents used in multimodal CT/MRI examination (such as allergy to the contrast agents, etc.);
  8. Pregnant or breastfeeding women;
  9. Patients currently participating in other clinical study trials;
  10. Other conditions determined by the investigator are not suitable for inclusion in this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
The participants in the experimental group will receive intravenous tirofiban combined with a standard MT protocol recommended by the current guidelines for the management of AIS
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.
Other Names:
  • Tirofiban
No Intervention: Control group
Patients are treated with MT therapy with no antiplatelet drugs (intravenous or intra-arterial) are administered. Besides, they will receive a standard pharmacological treatment as per current clinical guidelines.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite rates of target vessel revascularization and no symptomatic intracerebral haemorrhage
Time Frame: 24-72hours after thrombectomy;
Target vessel revascularization is defined as a modified thrombolysis in cerebral infarction (mTICI) grade after onepass thrombectomy procedure over grade 2b. Symptomatic intracerebral haemorrhage is defined according to per Safe Implementation of Thrombolysis in Stroke-Monitoring Study (SITS-MOST) criteria.
24-72hours after thrombectomy;

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recanalisation rates of the target vessel
Time Frame: 24-72 hours after thrombectomy;
Neuroimaging outcomes
24-72 hours after thrombectomy;
Dichotomized mRS score/ ordinal mRS score
Time Frame: The 90-day after randomisation
Functional prognosis of the patient，clinical outcomes
The 90-day after randomisation
Symptomatic intracerebral haemorrhage
Time Frame: By the end of the 90-day follow-up
procedure-related complications and adverse events
By the end of the 90-day follow-up
Death
Time Frame: By the end of the 90-day follow-up
procedure-related complications and adverse events
By the end of the 90-day follow-up
The number of thrombectomy times
Time Frame: By the end of the 90-day follow-up
Treatment information
By the end of the 90-day follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai East Hospital

Collaborators

Jinan Central Hospital
Ningbo No. 1 Hospital
Shanghai 6th People's Hospital
Shanghai 7th People's Hospital
Zhangzhou Municipal Hospital of Fujian Province
Xuchang Central Hospital

Investigators

  • Principal Investigator: Gang Li, Shanghai East Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 6, 2021

Primary Completion (Actual)

July 8, 2023

Study Completion (Actual)

October 15, 2023

Study Registration Dates

First Submitted

April 11, 2021

First Submitted That Met QC Criteria

April 15, 2021

First Posted (Actual)

April 20, 2021

Study Record Updates

Last Update Posted (Actual)

January 9, 2024

Last Update Submitted That Met QC Criteria

January 7, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-OPTIMISTIC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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