One Pass Tirofiban In Management of Ischemic Stroke Thrombectomy In China

NCT04851457 | Completed Phase 2 DMC

• 1 other identifier: 2021-OPTIMISTIC
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Stroke

Keywords

Acute Ischemic Stroke; Tirofiban; Mechanical thrombectomy; Revascularisation; Haemorrhage

Outcome Measures

Primary Outcomes (1)

• Composite rates of target vessel revascularization and no symptomatic intracerebral haemorrhage

  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 Outcomes (5)

• Recanalisation rates of the target vessel

  24-72 hours after thrombectomy;

• Dichotomized mRS score/ ordinal mRS score

  The 90-day after randomisation

• Symptomatic intracerebral haemorrhage

  By the end of the 90-day follow-up

• Death

  By the end of the 90-day follow-up

• The number of thrombectomy times

  By the end of the 90-day follow-up

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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.

Interventions

Intravenous tirofiban combination therapy 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.

Also known as: Tirofiban

Intervention group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

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

Study Sites (1)

Gang Li

Shanghai, Shanghai Municipality, 200123, China

Location

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MeSH Terms

Conditions

Ischemic Stroke; Hemorrhage

Interventions

Tirofiban

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tyrosine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Gang Li

  Shanghai East Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Images from each study site will be uploaded to the central server and all analyses will be performed by a trained physician at the study coordinating center who is unaware of group assignments. Similarly, follow-up assessments at 90 days after stroke will be conducted by a trained accessor in a blinded manner.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A prospective, randomized, controlled, open-Label, assessor-blind, multicenter clinical study

Study Record Dates

• First Submitted: April 11, 2021
• First Posted: April 20, 2021
• Study Start: April 6, 2021
• Primary Completion: July 8, 2023
• Study Completion: October 15, 2023
• Last Updated: January 9, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)