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โ† Trials
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Intravenous Thrombolysis and NOAC

RecruitingPhase 3Ages 18 Years - anyAllSecond Affiliated Hospital, Zhejiang University, โ€ฆ
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In plain words

What the trial is, and whether it could suit you

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 anim

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ 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๏ผš 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 โ‰ฅ 180 mmHg or diastolic blood pressure โ‰ฅ 100 mmHg 12) Acute bleeding tendency, including platelet count \< 100 ร— 10โน/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 โ‰ฅ 1/3 of the middle cerebral artery supply area) (4) The judgment is left to the discretion of the investigator
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What it tests

  • Intravenous thrombolysis
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Where

2 sites
Second Affiliated Hospital of Zhejiang University, School of Medicine, Hangzhou
Hangzhou, China
The First People's Hospital of Wenling
Taizhou, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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