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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04851457
Recruitment Status : Not yet recruiting
First Posted : April 20, 2021
Last Update Posted : April 20, 2021
Sponsor:
Collaborators:
Shanghai 6th People's Hospital
Qilu Hospital of Shandong University
Ningbo No. 1 Hospital
Information provided by (Responsible Party):
Shanghai East Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Ischemic Stroke Drug: Intravenous tirofiban combination therapy Phase 2 Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A prospective, randomized, controlled, open-Label, assessor-blind, multicenter clinical study
Masking: Single (Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : May 2021
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : October 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ischemic Stroke
Drug Information available for: Tirofiban

Arms and Interventions
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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 Name: 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Recanalisation rates of the target vessel [ Time Frame: 24-72 hours after thrombectomy; ]
    Neuroimaging outcomes

  2. Dichotomized mRS score/ ordinal mRS score [ Time Frame: The 90-day after randomisation ]
    Functional prognosis of the patient，clinical outcomes

  3. Symptomatic intracerebral haemorrhage [ Time Frame: By the end of the 90-day follow-up ]
    procedure-related complications and adverse events

  4. Death [ Time Frame: By the end of the 90-day follow-up ]
    procedure-related complications and adverse events

  5. The number of thrombectomy times [ Time Frame: By the end of the 90-day follow-up ]
    Treatment information


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female between the ages of 18 and 80;
  2. Acute ischemic stroke patients within 4.5-24 hours of stroke onset, with NIHSS scores > 5;
  3. Patients with large vessel occlusion including occlusion of the internal carotid artery (ICA) termination or middle cerebral artery (MCA, M1, or M2 segment), and who are scheduled to receive arterial thrombectomy;
  4. Complete an assessment with multimodal CT and meet the criteria as follow: penumbra volume > 10ml, infarct core volume < 70ml, mismatch ratio > 1.2;
  5. Patients planning to receive arterial thrombectomy treatment;
  6. All patients (or guardians of patients) provided written informed consent.

Exclusion Criteria:

  1. Patients with a medical history of atrial fibrillation or atrial flutter, or a 12-lead electrocardiogram at admission, showing atrial flutter or atrial fibrillation;
  2. Patients who have received intravenous thrombolysis;
  3. Pre-existing functional impairment with an mRS score ≥ 2;
  4. With severe comorbidities (e.g. severe cardiopulmonary insufficiency, advanced malignancy with an expected survival of less than 90d);
  5. More than 1/3 areas of hypodense ischaemic changes supplied by the middle cerebral artery on baseline CT;
  6. Patients with known hypersensitivity or contraindications to the use of tirofiban;
  7. Patients with known hypersensitivity or contraindications to the use of contrast agents in multimodal CT/MRI examinations;
  8. Pregnant or lactating women;
  9. Patients who are currently participating in other clinical trial;
  10. Other conditions judged by the investigator to be inappropriate for inclusion in the clinical study.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04851457


Contacts
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Contact: Gang Li +8618017187086 ligang@tongji.edu.cn
Contact: Feifeng Liu +8615121100573 liufeifeng7@163.com

Locations
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China, Shanghai
Gang Li
Shanghai, Shanghai, China, 200123
Sponsors and Collaborators
Shanghai East Hospital
Shanghai 6th People's Hospital
Qilu Hospital of Shandong University
Ningbo No. 1 Hospital
Investigators
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Principal Investigator: Gang Li Shanghai East Hospital
More Information
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Publications:

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Responsible Party: Shanghai East Hospital
ClinicalTrials.gov Identifier: NCT04851457    
Other Study ID Numbers: 2021-OPTIMISTIC
First Posted: April 20, 2021    Key Record Dates
Last Update Posted: April 20, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Shanghai East Hospital:
Acute Ischemic Stroke
Tirofiban
Mechanical thrombectomy
Revascularisation
Haemorrhage
Additional relevant MeSH terms:
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Stroke
Ischemic Stroke
Cerebral Infarction
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
 Pathologic Processes
Brain Infarction
Brain Ischemia
Infarction
Necrosis
Tirofiban
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors