Intravenous Thrombolysis and NOAC

Last updated: February 20, 2025
Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Overall Status: Active - Recruiting

Phase

3

Condition

Stroke

Blood Clots

Thrombosis

Treatment

Intravenous thrombolysis

Clinical Study ID

NCT06749834
I-NOAC
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients with clinical signs of acute ischemic stroke within 24 hours of onset orawakening with stroke (if within 24 hours from the midpoint of sleep). Patients withAIS within 4.5-24 hours of onset must meet the IVT inclusion criteria specified inthe 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

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, intraventricularhemorrhage, subarachnoid hemorrhage, epidural hematoma, etc.) 2) Previous history ofintracranial hemorrhage 3) Severe head trauma or stroke history within the last 3months 4) Intracranial tumors, giant intracranial aneurysms 5) Intracranial orspinal surgery within the recent 3 months 6) Major surgical procedures within thelast 2 weeks 7) Gastrointestinal or urinary tract bleeding within the last 3 weeks
  2. Active visceral bleeding 9) Aortic arch dissection 10) Arterial puncture in asite 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 bloodpressure ≥ 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) Bloodsugar < 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 judgmentis left to the discretion of the investigator

Study Design

Total Participants: 280
Treatment Group(s): 1
Primary Treatment: Intravenous thrombolysis
Phase: 3
Study Start date:
January 27, 2025
Estimated Completion Date:
June 30, 2027

Study Description

In this prospective cohort study, the investigators aim to recruit consecutive IS-NOAC patients who met the inclusion criteria. The investigators sought to determine the safety and efficacy of IVT in acute ischemic stroke patients on NOACs. It is hypothesized that for IS-DOAC patients with the last intake of NOAC within 48 hours, IVT improved neurological outcomes with acceptable safety compared to a cohort of acute IS-NOAC patients excluded from IVT.

Connect with a study center

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

    Hangzhou, Zhejiang 310000
    China

    Site Not Available

  • The First People's Hospital of Wenling

    Taizhou, Zhejiang 317500
    China

    Active - Recruiting

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