Giving IV clot-busting medicine for ischemic stroke 4.5–24 hours after last known normal

A Multicenter, Retrospective, Observational Cohort Study on Intravenous Thrombolysis Beyond the Time Window for Acute Ischemic Stroke

This study looks back at adults with acute ischemic stroke who got intravenous clot-busting drugs 4.5–24 hours after they were last seen normal to see if those treatments helped their recovery.

Quick facts

• Study type: Observational
• Enrollment: 2600 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Xuanwu Hospital, Beijing (Academic / other)
• Locations: 1 site (Beijing)
• Trial ID: NCT07419997 on ClinicalTrials.gov

What this trial studies

This is a multicenter, retrospective, observational cohort study collecting past clinical records of adults with acute ischemic stroke who received intravenous thrombolysis 4.5–24 hours after last known well. Investigators will extract demographic and clinical data including age, sex, NIHSS, and mRS, and will compare clinical outcomes and safety signals among patients treated with agents such as alteplase or tenecteplase. Because it is retrospective, treatment decisions were made clinically and the study will analyze real-world effectiveness and complications rather than assigning treatments prospectively. Results will aim to identify which patients, if any, might benefit from later thrombolytic therapy and what risks are associated.

Who should consider this trial

Good fit: Adults aged 18 or older with acute ischemic stroke who were treated with IV thrombolysis between 4.5 and 24 hours after last known well and whose clinical records include NIHSS and mRS are the ideal candidates for inclusion.

Not a fit: Patients with hemorrhagic stroke, those treated outside the 4.5–24 hour window, or those lacking complete clinical records or who had clear contraindications to thrombolysis are unlikely to be helped by this analysis.

Why it matters

Potential benefit: If successful, the findings could support extending IV thrombolytic treatment to some patients up to 24 hours after their last known normal, potentially improving recovery and reducing long-term disability.

How similar studies have performed: Previous randomized and imaging-selected trials have shown benefit of thrombolysis or reperfusion strategies up to about 9 hours in selected patients, but using IV thrombolysis out to 24 hours is largely untested and mainly supported by small observational reports.

Eligibility criteria

1. Patients with acute ischemic stroke, regardless of gender;
2. Age ≥ 18 years old;
3. Time from onset to treatment within 4.5 - 24 hours (the onset time refers to the last time when they appeared normal);
4. Complete relevant clinical data (including gender, age, mRS, NIHSS, etc.).

Where this trial is running

Beijing

• Xuanwu Hospital Capital Medical University, Beijing, Beijing 100053 — Beijing, China (Recruiting)

Study contacts

• Study coordinator: Xin Xing, MD

Conditions Stroke; Acute ischemic stroke; Alteplase; Tenecteplase; Stroke at 4.5 to 24 Hours