One Pass Tirofiban In Management of Ischemic Stroke Thrombectomy In China

NCT ID: NCT04851457

Last Updated: 2024-01-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-06
• Study Completion Date: 2023-10-15

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 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.

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.

Conditions

Ischemic Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Intravenous tirofiban combination therapy

Intervention Type: DRUG

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Tirofiban

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai 6th People's Hospital

OTHER

Sponsor Role: collaborator

Ningbo No. 1 Hospital

OTHER

Sponsor Role: collaborator

Zhangzhou Municipal Hospital of Fujian Province

OTHER

Sponsor Role: collaborator

Shanghai 7th People's Hospital

OTHER

Sponsor Role: collaborator

Jinan Central Hospital

OTHER

Sponsor Role: collaborator

Xuchang Central Hospital

UNKNOWN

Sponsor Role: collaborator

Shanghai East Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gang Li

Role: PRINCIPAL_INVESTIGATOR

Shanghai East Hospital

Locations

Gang Li

Shanghai, Shanghai Municipality, China

Countries

China

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Other Identifiers

2021-OPTIMISTIC

Identifier Type: -

Identifier Source: org_study_id