Using intravenous thrombolysis for patients on new oral anticoagulants after a stroke

Intravenous Thrombolytic Therapy in Acute Ischemic Stroke Patients on New Oral Anticoagulants

This study is testing if a common stroke treatment can safely help people who have recently taken new blood thinners after having a stroke.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 280 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University (other)
• Locations: 2 sites (Hangzhou, Zhejiang and 1 other locations)
• Trial ID: NCT06749834 on ClinicalTrials.gov

What this trial studies

This prospective cohort study aims to evaluate the safety and efficacy of intravenous thrombolysis (IVT) in patients experiencing acute ischemic stroke (AIS) who have taken new oral anticoagulants (NOACs) within the last 48 hours. The study will recruit patients who meet specific inclusion criteria, including those with clinical signs of AIS and recent NOAC usage. The hypothesis is that IVT can improve neurological outcomes in these patients without significantly increasing the risk of severe bleeding complications. The findings could help redefine treatment guidelines for AIS patients on NOACs.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older who have experienced acute ischemic stroke within 24 hours and have taken NOACs within the last 48 hours.

Not a fit: Patients who have contraindications for intravenous thrombolysis, such as a history of intracranial hemorrhage or severe head trauma, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enable more patients on NOACs to receive effective treatment for acute ischemic stroke, potentially improving their recovery outcomes.

How similar studies have performed: While there is limited data on this specific approach, previous animal studies suggest that NOACs do not significantly increase the risk of hemorrhagic transformation, indicating potential for success in this area.

Eligibility criteria

Inclusion Criteria:

1. Patients with clinical signs of acute ischemic stroke within 24 hours of onset or awakening with stroke (if within 24 hours from the midpoint of sleep). Patients with AIS within 4.5-24 hours of onset must meet the IVT inclusion criteria specified in the guideline
2. Patients with new oral anticoagulants usage within 4-48 hours of onset;
3. Patients ≥ 18 years old
4. Informed consent has been obtained depending on local ethics requirements.

Exclusion Criteria:

1. Intended to proceed to endovascular treatment
2. With APTT \>40s
3. Pre-stroke mRS score \> 2
4. Contraindications for IVT：

1\) Intracranial hemorrhage (including parenchymal hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, epidural hematoma, etc.) 2) Previous history of intracranial hemorrhage 3) Severe head trauma or stroke history within the last 3 months 4) Intracranial tumors, giant intracranial aneurysms 5) Intracranial or spinal surgery within the recent 3 months 6) Major surgical procedures within the last 2 weeks 7) Gastrointestinal or urinary tract bleeding within the last 3 weeks 8) Active visceral bleeding 9) Aortic arch dissection 10) Arterial puncture in a site within the last 1 week that is not easy to compress and stop bleeding 11) Elevated blood pressure: Systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 100 mmHg 12) Acute bleeding tendency, including platelet count \< 100 × 10⁹/L or other conditions 13) Received low-molecular-weight heparin treatment within 24 hours 14) Oral anticoagulants (warfarin) with INR \> 1.7 or PT \> 15 s 15) Blood sugar \< 2.8 or \> 22.22 mmol/L 16) Head CT or MRI indicates large-area infarction (infarction area ≥ 1/3 of the middle cerebral artery supply area) (4) The judgment is left to the discretion of the investigator

Where this trial is running

Hangzhou, Zhejiang and 1 other locations

• Second Affiliated Hospital of Zhejiang University, School of Medicine, Hangzhou — Hangzhou, Zhejiang, China (NOT_YET_RECRUITING)
• The First People's Hospital of Wenling — Taizhou, Zhejiang, China (RECRUITING)

Study contacts

• Study coordinator: Min Lou, PhD, MD

Conditions: Acute Ischemic Stroke, Intravenous thrombolysis, outcome, NOAC