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Intra-arterial alteplase trial protocol for large vessel occlusion stroke aims to improve outcomesTrial plans to test new stroke treatment method for patients

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Key Takeaway
Note that this is a trial protocol; no clinical results for intra-arterial alteplase are currently available.

This Phase 3 multicentre trial protocol evaluates the efficacy of intra-arterial alteplase for patients with symptomatic large vessel occlusion (LVO) stroke. The study population consists of 440 adults (age 18 years and older) who have undergone mechanical thrombectomy (MT) with successful or complete reperfusion.

The intervention is a 15 min intra-arterial infusion of alteplase (1.0 mg/mL, maximum dose 20 mg) compared to no intra-arterial thrombolysis. The primary outcome is the proportion of patients achieving a modified Rankin Scale (mRS) of 0-1 at 90 days.

Secondary outcomes include the presence of hypoperfusion on brain CT perfusion at 36 +/- 24 hours post-randomization, infarct expansion, Barthel Index, quality of life, mortality, and symptomatic intracerebral hemorrhage. Safety and tolerability data are not yet available.

Because this is a study protocol, no results are reported. The trial aims to determine if rescue intra-arterial thrombolysis improves clinical outcomes in patients with LVO stroke after successful mechanical thrombectomy. Clinical application is currently limited by the lack of available data.

How this fits prior evidence

How this fits prior evidence: This protocol addresses a gap in the management of acute ischemic stroke by investigating rescue intra-arterial thrombolysis. It follows other investigations into stroke management, such as the Phase 3 trial protocol evaluating intravenous loberamisal for acute ischemic stroke management. It does not relate to the findings regarding BNT162b2 vaccination, music-based interventions for gait, iNKT cell activators, or nanozyme-hydrogel systems.

When a person suffers a major stroke, every second counts. Doctors often use a procedure called mechanical thrombectomy to physically remove a clot from a large blood vessel. This trial looks at what happens next. It aims to see if giving a medicine called alteplase directly into the artery can improve the final outcome for these patients.

The study will involve 440 adults who have a large vessel occlusion, which is a serious blockage of a main artery in the brain. These patients will have already undergone a successful procedure to open the vessel. The researchers want to know if a 15-minute infusion of alteplase helps them achieve a better quality of life and better physical function after 90 days.

It is important to note that this is currently a study protocol. This means the researchers have designed the plan and are preparing to start, but they have not finished the study yet. Because the trial is in the planning stages, there are no results or safety data available at this time.

What this means for you:
This planned trial will test if a specific medicine improves recovery for patients after a major stroke.

Common questions

What is the goal of this new study?

The trial aims to determine if a medicine called alteplase, delivered directly into an artery, improves clinical outcomes for adults who have a large vessel occlusion stroke and have already undergone a mechanical thrombectomy.

Who is eligible for this study?

The study is designed for adults aged 18 and older who have a symptomatic large vessel occlusion stroke and have achieved successful or complete reperfusion during a mechanical thrombectomy procedure.

Are there results available from this trial yet?

No, results are not available yet. This is a study protocol, which means it is a plan for a study that is being organized. Results regarding safety or effectiveness have not been reported.

Study Details

Study typeRct
Sample sizen = 440
EvidenceLevel 2
Follow-up216.0 mo
PublishedAug 2026
View Original Abstract ↓
RATIONALE: The potential value of rescue intra-arterial thrombolysis in patients with large vessel occlusion (LVO) stroke treated with mechanical thrombectomy (MT) remains to be validated in randomised trials. AIM: The Chemical Optimization of Cerebral Embolectomy 2 (CHOICE 2) trial is designed to confirm whether adjunctive intra-arterial alteplase, administered after successful MT, improves clinical outcomes in patients with LVO stroke. SAMPLE SIZE ESTIMATES: A total of 440 patients (220 per group) randomised in a 1:1 ratio to receive intra-arterial thrombolysis or not intra-arterial thrombolysis provides 80% statistical power to detect a 14% absolute benefit in the primary endpoint (the proportion of patients achieving modified Rankin Scale (mRS) 0-1 at 90 days), assuming a rate of 40% in the control group, a 5% two-sided type I error. The sample size also provides >95% power for detecting an 18% absolute benefit in secondary imaging endpoints, assuming a 58% rate in the control group. METHODS AND DESIGN: Multicentre, randomised, open, blinded end-point assessment phase III trial. Eligible patients are adults (≥18 years) with symptomatic LVO who undergo MT with successful or complete reperfusion at end of the procedure. Patients in the intervention group will receive a 15 min intra-arterial infusion of alteplase (1.0 mg/mL, maximum dose 20 mg). STUDY OUTCOMES: The primary outcome is the proportion of patients achieving excellent functional outcome (mRS 0-1) at 90 days. Key secondary outcomes are the presence of hypoperfusion on brain CT perfusion at 36±24 hours post randomisation, infarct expansion, Barthel Index and quality of life. Mortality and symptomatic intracerebral haemorrhage will also be evaluated. DISCUSSION: This trial will provide evidence whether rescue intra-arterial thrombolysis improves clinical outcome in patients with LVO stroke who achieve successful or complete angiographic reperfusion following MT.
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