Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT06749834

Intravenous Thrombolysis and NOAC

Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2025-02-24

280

Participants Needed

2

Research Sites

126 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

New oral anticoagulants (NOACs), including rivaroxaban, apixaban, dabigatran, and edoxaban, have become the first-line therapy for preventing ischemic stroke associated with non-valvular atrial fibrillation (NVAF). Despite the effectiveness of NOACs in preventing thromboembolic events, approximately 1% to 2% of patients taking NOACs experience an ischemic stroke annually. Intravenous thrombolysis is an important means of treating acute ischemic stroke (AIS). However, due to concerns about the risk of symptomatic intracranial hemorrhage (sICH) or other severe bleeding complications, current guidelines still consider the use of NOACs within 48 hours before symptom onset as a contraindication to intravenous thrombolysis. Epidemiological data suggest that this may result in up to 18% of AF patients being unable to receive intravenous thrombolysis when they have an AIS episode. Previous animal experiments have shown that NOACs do not increase the risk of hemorrhagic transformation after intravenous thrombolysis. Pharmacokinetic studies have demonstrated that 24 to 48 hours after taking NOACs, the anti-Xa level in patients is relatively low (\<0.5 U/mL). In recent years, multiple retrospective studies and meta-analyses have shown that prior use of NOACs does not increase the risk of sICH in AIS patients receiving intravenous thrombolysis, and there are no significant differences in functional outcomes at 3 months. With solid pharmacokinetic and retrospective clinical evidence to support, it is hypothesized that IVT are safe in IS-NOAC patient. The investigators hereby propose a prospective multicenter study to determine the efficacy and safety of IVT in acute IS-NOAC.

CONDITIONS

Official Title

Intravenous Thrombolysis and NOAC

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with signs of acute ischemic stroke within 24 hours of onset or awakening with stroke (if within 24 hours from midpoint of sleep)
  • Patients with AIS within 4.5-24 hours of onset who meet IVT inclusion criteria in guidelines
  • Use of new oral anticoagulants within 4 to 48 hours before stroke onset
  • Patients aged 18 years or older
  • Informed consent obtained according to local ethics requirements
Not Eligible

You will not qualify if you...

  • Planned endovascular treatment
  • Activated partial thromboplastin time (APTT) greater than 40 seconds
  • Pre-stroke modified Rankin Scale score greater than 2
  • Contraindications for intravenous thrombolysis including:
  1. Any intracranial hemorrhage
  2. Previous intracranial hemorrhage history
  3. Severe head trauma or stroke within last 3 months
  4. Intracranial tumors or giant aneurysms
  5. Intracranial or spinal surgery within past 3 months
  6. Major surgery within last 2 weeks
  7. Gastrointestinal or urinary tract bleeding within last 3 weeks
  8. Active internal bleeding
  9. Aortic arch dissection
  10. Recent arterial puncture in difficult-to-compress site within last week
  11. High blood pressure (systolic 65 180 mmHg or diastolic 65 100 mmHg)
  12. Acute bleeding tendency including low platelet count (<100 x 10^9/L)
  13. Low-molecular-weight heparin treatment within last 24 hours
  14. Warfarin use with INR > 1.7 or PT > 15 seconds
  15. Blood sugar less than 2.8 or greater than 22.22 mmol/L
  16. Large-area brain infarction involving 65 1/3 of middle cerebral artery area on head CT or MRI
  • Other investigator discretion contraindications

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 2 locations

1

Second Affiliated Hospital of Zhejiang University, School of Medicine, Hangzhou

Hangzhou, Zhejiang, China, 310000

Not Yet Recruiting

2

The First People's Hospital of Wenling

Taizhou, Zhejiang, China, 317500

Actively Recruiting

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Research Team

M

Min Lou, PhD, MD

CONTACT

W

Wansi Zhong, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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