Comparing Tirofiban and Alteplase for Stroke Treatment Before Thrombectomy

Intravenous Adjuvant With Tirofiban Versus Alteplase Before Mechanical Thrombectomy in Acute Ischemic Stroke Patients With Large Vessel Occlusion: a Multicenter, Open Label, Randomized Controlled Trial.

This study is testing whether a new drug called tirofiban can work better and safer than the standard treatment alteplase for people having a stroke caused by a blocked blood vessel before they undergo a procedure to remove the blockage.

Quick facts

• Phase: Phase2; Phase3
• Study type: Interventional
• Enrollment: 800 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Xinqiao Hospital of Chongqing (Academic / other)
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT05728333 on ClinicalTrials.gov

What this trial studies

This trial evaluates the efficacy and safety of intravenous tirofiban compared to alteplase in patients with acute ischemic stroke caused by large vessel occlusion prior to endovascular thrombectomy. It aims to address the limitations of alteplase, such as its narrow time window and risk of intracranial hemorrhage, by exploring tirofiban as an alternative treatment. The study will involve randomized controlled trials to directly compare the two medications in this specific patient population.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 years or older presenting with acute ischemic stroke symptoms due to large vessel occlusion within specific time frames.

Not a fit: Patients with contraindications to intravenous thrombolysis or those with evidence of hemorrhage on imaging may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a safer and more effective treatment option for patients suffering from acute ischemic stroke.

How similar studies have performed: While other studies have explored the use of alteplase in similar contexts, this direct comparison with tirofiban is novel and has not been previously tested.

Eligibility 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.

Where this trial is running

Hangzhou, Zhejiang

• Hangzhou First People's Hospital — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Principal investigator: Congguo Yin, Doctor — Hangzhou First Hospital of Zhejiang University
• Study coordinator: Hongfei Sang, Doctor

Conditions Stroke, Acute Ischemic; endovascular thrombectomy; large vessel occlusion; intravenous thrombolysis; tirofiban