Stroke, Acute Ischemic
Conditions
Keywords
endovascular thrombectomy, large vessel occlusion, intravenous thrombolysis, tirofiban
Brief summary
In patients with acute ischemic stroke secondary to large vessel occlusion, the role of intravenous adjunctive medications, such as tirofiban, or thrombolysis before endovascular thrombectomy has not been well investigated. This trial aim to evaluate the efficacy and safety of intravenous tirofiban versus thrombolysis for acute ischemic stroke patients with large vessel occlusion piror to endovascular thrombectomy.
Detailed description
Intravenous thrombolysis bridging with endovascular treatment (EVT) has been proven to be effective therapy in acute ischemic stroke patients due to large vessel occlusion (LVO). Several randomized controlled trials, aiming to explore the benefits and risks of intravenous thrombolysis prior to EVT in LVO stroke, have suggested that intravenous thrombolysis should not be omitted. Although intravenous thrombolysis results in successful reperfusion in approximately 10% to 20% of LVO patients, obviating the need for EVT, it has limitations. First, the time window for intravenous thrombolysis is narrow with strict indications and contraindications. Second, it may increase the risk of intracranial hemorrhage. Furthermore, thrombolysis is expensive. The above limitations lead to a very low proportion of patients who receive intravenous thrombolysis. Tirofiban is a selective IIb/IIIa receptor inhibitor, and it's effective in preventing thrombosis complications. Intravenous tirofiban has been increasingly used as an adjunctive treatment in acute ischemic stroke patients receiving EVT. However, a direct comparison between tirofiban and thrombolysis in LVO stroke has not been performed. We therefore conduct a randomized controlled trials to evaluate the efficacy and safety of intravenous tirofiban versus thrombolysis prior to EVT for acute ischemic stroke patients with LVO.
Interventions
DRUGTirofiban
Intravenous tirofiban before endovascular thrombectomy.
DRUGThrombolysis
Intravenous thrombolysis before endovascular thrombectomy.
Sponsors
Xinqiao Hospital of Chongqing
Affiliated Hangzhou First People's Hospital, Westlake University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Aged 18 years or older; 2. Acute ischemic stroke patient eligible for intravenous thrombolysis who are present within 4.5 hours of last known well, or present within 4.5-24 hours of last known well with demonstrated salvageable brain tissue (defined as an estimated ischemic core volume \<70 ml, a mismatch ratio ≥1.8 and a mismatch volume ≥15 ml); 3. Occlusion of the internal carotid artery, M1 or M2 segment of the middle cerebral artery, or basilar artery confirmed by CTA or MRA; 4. Endovascular thrombectomy is planned by clinical care team; 5. Informed written consent obtained from patients or their legal representatives.
Exclusion criteria
1. Acute intracranial hemorrhage on admission; 2. Contraindication to intravenous thrombolytics or tirofiban; 3. Pretreatment with intravenous thrombolysis after index stroke; 4. Significant pre-stroke disability defined as a modified Rankin scale (mRS) score greater than 2; 5. Known pregnancy or lactation; 6. Allergy to radiographic contrast agents, nickel, titanium metals or their alloys; 7. Current participation in other drug clinical trials; 8. Arterial tortuosity and/or other arterial disease that would prevent the thrombectomy device from reaching the target vessel; 9. Patient with a preexisting neurological or psychiatric disease that would confound the outcome assessments; 10. Radiologically confirmed mass effect or intracranial tumor except for small meningioma; 11. Radiologically confirmed intracranial arteriovenous malformation or aneurysm. 12. Any terminal disease with a life expectancy less than half a year.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional independence | 90 days post-endovascular treatment | modified Rankin scale score of 0 to 2. (The modified Rankin scale scores range from 0 to 6, with 0 indicating no disability, 1 no clinically significant disability, 2 slight disability, 3 moderate disability but able to walk unassisted, 4 moderately severe disability, 5 severe disability, and 6 death) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Modified Rankin scale score at 90 days | 90 days post-endovascular treatment | — |
| Excellent outcome | 90 days post-endovascular treatment | Modified Rankin Scale score 0 to 1, or Modified Rankin scale score return to baseline |
| Successful reperfusion before thrombectomy | Prior to thrombectomy | The expanded Thrombolysis In Cerebral Infarction (eTICI) reperfusion grading system is a 6-point scale: 0 indicates no reperfusion noted; 1, reduction in thrombus without filling of distal arterial branches; 2a, reperfusion of \<50% of the territory; 2b, a reperfusion of ≥50% of the territory; 2c, near-complete perfusion with distal slow flow or presence of small cortical emboli; and 3, complete reperfusion. Successful reperfusion at initial angiogram prior to thrombectomy was defined as an eTICI grade of 2b, 2c, or 3 on the first intracranial angiogram. |
| Successful reperfusion on the final angiogram | End-of-procedure angiography | Achieve eTICI 2b, 2c or 3 |
| First pass excellent reperfusion | After the first thrombectomy pass | Achieve eTICI 2c or 3 |
| First pass successful reperfusion | After the first thrombectomy pass | Achieve eTICI 2b, 2c or 3 |
| Time from puncture to reperfusion or procedure completion | from puncture to reperfusion or procedure completion | — |
| Use of balloon angioplasty or stenting during procedure | During endovascular treatment | — |
| National Institutes of Health Stroke Scale score at 5 to 7 days or discharge if earlier | At 5 to 7 days post-endovascular treatment or discharge if earlier | Scores on National Institutes of Health Stroke Scale (NIHSS) range from 0 to 42, with less scores indicating less severe neurologic deficits. |
| EQ-5D-5L scale score at 90 days | 90 days post-endovascular treatment | Scores on the European Quality Five-Dimension Five-Level Self-Report Questionnaire (EQ-5D-5L) range from -0.39 to 1, with higher scores indicating a better quality of life; 0 is the value of a health state equivalent to death. |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORCongguo Yin, Doctor
Hangzhou First Hospital of Westlake University
PRINCIPAL_INVESTIGATORZhongming Qiu, Doctor
The 903rd Hospital of PLA, China
Outcome results
None listed