Intravenous Tirofiban Versus Alteplase Before Mechanical Thrombectomy in Stroke

• Status: Not yet recruiting
• Trial end date: 2027-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Xinqiao Hospital of Chongqing
• Collaborator: Zhejiang University
• Treatments: Tirofiban; Tissue Plasminogen Activator

Criteria

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.

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.