Back to resultsOne Pass Tirofiban In Management of Ischemic Stroke Thrombectomy In China (OPTIMISTIC)
Primary Purpose
Ischemic Stroke
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Intravenous tirofiban combination therapy
Sponsored by
About this trial
This is an interventional treatment trial for Ischemic Stroke focused on measuring Acute Ischemic Stroke, Tirofiban, Mechanical thrombectomy, Revascularisation, Haemorrhage
Eligibility Criteria
Inclusion Criteria:
- Male or female between the ages of 18 and 80;
- Acute ischemic stroke patients within 4.5-24 hours of stroke onset, with NIHSS scores > 5;
- 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;
- Complete an assessment with multimodal CT and meet the criteria as follow: penumbra volume > 10ml, infarct core volume < 70ml, mismatch ratio > 1.2;
- Patients planning to receive arterial thrombectomy treatment;
- All patients (or guardians of patients) provided written informed consent.
Exclusion Criteria:
- Patients with a medical history of atrial fibrillation or atrial flutter, or a 12-lead electrocardiogram at admission, showing atrial flutter or atrial fibrillation;
- Patients who have received intravenous thrombolysis;
- Pre-existing functional impairment with an mRS score ≥ 2;
- With severe comorbidities (e.g. severe cardiopulmonary insufficiency, advanced malignancy with an expected survival of less than 90d);
- More than 1/3 areas of hypodense ischaemic changes supplied by the middle cerebral artery on baseline CT;
- Patients with known hypersensitivity or contraindications to the use of tirofiban;
- Patients with known hypersensitivity or contraindications to the use of contrast agents in multimodal CT/MRI examinations;
- Pregnant or lactating women;
- Patients who are currently participating in other clinical trial;
- Other conditions judged by the investigator to be inappropriate for inclusion in the clinical study.
Sites / Locations
- Gang Li
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention group
Control group
Arm Description
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
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Recanalisation rates of the target vessel
Neuroimaging outcomes
Dichotomized mRS score/ ordinal mRS score
Functional prognosis of the patient，clinical outcomes
Symptomatic intracerebral haemorrhage
procedure-related complications and adverse events
Death
procedure-related complications and adverse events
The number of thrombectomy times
Treatment information
Full Information
NCT ID
NCT04851457
First Posted
April 11, 2021
Last Updated
April 15, 2021
Sponsor
Shanghai East Hospital
Collaborators
Shanghai 6th People's Hospital, Qilu Hospital of Shandong University, Ningbo No. 1 Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04851457
Brief Title
One Pass Tirofiban In Management of Ischemic Stroke Thrombectomy In China
Acronym
OPTIMISTIC
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 2021 (Anticipated)
Primary Completion Date
May 2022 (Anticipated)
Study Completion Date
October 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai East Hospital
Collaborators
Shanghai 6th People's Hospital, Qilu Hospital of Shandong University, Ningbo No. 1 Hospital
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke
Keywords
Acute Ischemic Stroke, Tirofiban, Mechanical thrombectomy, Revascularisation, Haemorrhage
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
A prospective, randomized, controlled, open-Label, assessor-blind, multicenter clinical study
Masking
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.
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Intravenous tirofiban combination therapy
Other Intervention Name(s)
Tirofiban
Intervention Description
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.
Primary Outcome Measure Information:
Title
Composite rates of target vessel revascularization and no symptomatic intracerebral haemorrhage
Description
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.
Time Frame
24-72hours after thrombectomy;
Secondary Outcome Measure Information:
Title
Recanalisation rates of the target vessel
Description
Neuroimaging outcomes
Time Frame
24-72 hours after thrombectomy;
Title
Dichotomized mRS score/ ordinal mRS score
Description
Functional prognosis of the patient，clinical outcomes
Time Frame
The 90-day after randomisation
Title
Symptomatic intracerebral haemorrhage
Description
procedure-related complications and adverse events
Time Frame
By the end of the 90-day follow-up
Title
Death
Description
procedure-related complications and adverse events
Time Frame
By the end of the 90-day follow-up
Title
The number of thrombectomy times
Description
Treatment information
Time Frame
By the end of the 90-day follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female between the ages of 18 and 80;
Acute ischemic stroke patients within 4.5-24 hours of stroke onset, with NIHSS scores > 5;
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;
Complete an assessment with multimodal CT and meet the criteria as follow: penumbra volume > 10ml, infarct core volume < 70ml, mismatch ratio > 1.2;
Patients planning to receive arterial thrombectomy treatment;
All patients (or guardians of patients) provided written informed consent.
Exclusion Criteria:
Patients with a medical history of atrial fibrillation or atrial flutter, or a 12-lead electrocardiogram at admission, showing atrial flutter or atrial fibrillation;
Patients who have received intravenous thrombolysis;
Pre-existing functional impairment with an mRS score ≥ 2;
With severe comorbidities (e.g. severe cardiopulmonary insufficiency, advanced malignancy with an expected survival of less than 90d);
More than 1/3 areas of hypodense ischaemic changes supplied by the middle cerebral artery on baseline CT;
Patients with known hypersensitivity or contraindications to the use of tirofiban;
Patients with known hypersensitivity or contraindications to the use of contrast agents in multimodal CT/MRI examinations;
Pregnant or lactating women;
Patients who are currently participating in other clinical trial;
Other conditions judged by the investigator to be inappropriate for inclusion in the clinical study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gang Li
Phone
+8618017187086
Email
ligang@tongji.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Feifeng Liu
Phone
+8615121100573
Email
liufeifeng7@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gang Li
Organizational Affiliation
Shanghai East Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gang Li
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200123
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
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One Pass Tirofiban In Management of Ischemic Stroke Thrombectomy In China
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