Intravenous Tirofiban Versus Alteplase Before Mechanical Thrombectomy in Stroke

Phase 2

Recruiting

• Conditions: Stroke, Acute Ischemic
• Interventions: Drug: Tirofiban; Drug: Alteplase

• Registration Number: NCT05728333
• Lead Sponsor: Xinqiao Hospital of Chongqing

Brief Summary

In patients with acute ischemic stroke secondary to large vessel occlusion, the role of intravenous adjunctive medications, such as tirofiban, or alteplase before endovascular thrombectomy has not been well investigated. This trial aim to evaluate the efficacy and safety of intravenous tirofiban versus alteplase for acute ischemic stroke patients with large vessel occlusion piror to endovascular thrombectomy.

Detailed Description

Intravenous alteplase 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 alteplase prior to EVT in LVO stroke, have suggested that intravenous alteplase should not be omitted. Although intravenous alteplase 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 alteplase is narrow with strict indications and contraindications. Second, it may increase the risk of intracranial hemorrhage. Furthermore, alteplase 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 alteplase in LVO stroke has not been performed. We therefore conduct a randomized controlled trials to evaluate the efficacy and safety of intravenous tirofiban versus alteplase prior to EVT for acute ischemic stroke patients with LVO.

Study Timeline

• Study First Submitted: 2023-02-02
• Study First Submitted QC: 2023-02-14
• Study First Posted: 2023-02-15
• Study Start: 2023-11-28
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-27
• Last Update Posted: 2024-01-03
• Primary Completion: 2027-03-01
• Study Completion: 2027-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

1. Aged 18 years or older.

2. Presenting with acute ischemic stroke symptom.

3. Time from onset to hospital arrival:

   • (1) within 4.5 hours
   • (2) 4.5-9.0 hours, image inclusion criteria for the EXTEND trial must be met
   • (3) > 4.5 hours but within 24 hours, image inclusion criteria for the WAKE-UP trial must be met.

4. Eligible for intravenous thrombolysis.

5. Occlusion of the internal carotid artery, M1 or M2 segment of the middle cerebral artery, vertebrobasilar artery confirmed by CTA, MRA, or DSA.

6. Informed consent obtained from patients or their legal representatives.

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Exclusion Criteria

1. CT or MR evidence of hemorrhage (the presence of micro-bleeds is allowed);
2. Contraindications of IV rt-PA or tirofiban;
3. Contraindication to radiographic contrast agents, nickel, titanium metals or their alloys;
4. Arterial tortuosity and/or other arterial disease that would prevent the device from reaching the target vessel;
5. Patients with a preexisting neurological or psychiatric disease that would confound the neurological functional evaluations;
6. CT or MRI evidence of mass effect or intracranial tumor (except small eningioma);
7. CT or MRI evidence of cerebral vasculitis;
8. CTA or MRA evidence of intracranial arteriovenous malformations or aneurysms;
9. Any terminal illness with life expectancy less than 6 months.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tirofiban	Tirofiban	Tirofiban will be administrated intravenously before endovascular thrombectomy.
Alteplase	Alteplase	Alteplase will be administrated intravenously before endovascular thrombectomy.

Primary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Hangzhou First People's Hospital; 🇨🇳 Hangzhou, Zhejiang, China