Clot-Dissolving Drug Through a Vein for Stroke in People on Newer Blood Thinners
Tests a clot-dissolving drug in adults with stroke who take newer blood thinners.
Key facts
- Who runs it
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Where
- Hangzhou and Taizhou, ChinaSee the 2 sites
- Trial code
- Registry title
- Intravenous Thrombolysis and NOAC
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 280 people, planned
- Started
- 27 Jan 2025
- Expected to end
- 30 Jun 2027
- Type of study
- Interventional, 2 groupsOne group gets no study treatment, for comparison.
- Treatments tested
- Intravenous thrombolysis
- Record updated
- 24 February 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with a new ischemic stroke who took a new oral blood thinner (NOAC) 4 to 48 hours before the stroke and could get a clot-dissolving drug through a vein.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Acute ischemic stroke within 24 hours of onset, or waking up with stroke symptoms (counted from the middle of sleep). Stroke 4.5 to 24 hours after onset must meet the guideline rules for clot-dissolving treatment.
- Earlier treatment
- Must have taken a new oral anticoagulant (NOAC) within 4 to 48 hours of stroke onset.
- Biomarker or test result
- APTT must not be above 40s.
Main reasons for not taking part
- Plans to have endovascular treatment
- Pre-stroke mRS score above 2
- Bleeding in the brain now or in the past
- Blood pressure of 180 mmHg or higher (top number) or 100 mmHg or higher (bottom number)
- Other reasons that make clot-dissolving treatment unsafe, such as recent major surgery, active bleeding, or low platelets
The registry criteria, word for word
Show all 9 criteriaShow less
Who can take part
- 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
- Patients with new oral anticoagulants usage within 4-48 hours of onset
- Patients ≥ 18 years old
- Informed consent has been obtained depending on local ethics requirements
Who cannot take part
- Pre-stroke mRS score > 2
- With APTT >40s
- 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
- Intended to proceed to endovascular treatment
- Contraindications for IVT：
Where in China
- Second Affiliated Hospital of Zhejiang University, School of Medicine, HangzhouHangzhou, ChinaContact: Min Lou, PhD, MDNot yet recruiting
- The First People's Hospital of WenlingTaizhou, ChinaContact: Hinlong HuoTaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The 2 groups in the trial
- Intravenous thrombolysisTreatment being tested
Patients will receive standard dose intravenous alteplase (0.9 mg/kg, the first 10% administered as an initial bolus and the remainder over a 1-hour period, with a maximum dose of 90 mg)，intravenous Tenecteplase(0.25mg/kg，administered as a single intravenous bolus injection over 5 - 10 seconds，with a maximum dose of 25 mg), intravenous reteplase (a bolus of 18 mg followed by a second bolus of 18 mg after 30 minutes) and intravenous prourokinase (rhPro-UK) (15 mg bolus followed by a 20 mg infusion over 30 minutes).
- Standard therapyNo study treatment, for comparison
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Intravenous Thrombolytic Therapy in Acute Ischemic Stroke Patients on New Oral Anticoagulants
- Plain-language title
- Clot-Dissolving Drug Through a Vein for Stroke in People on Newer Blood ThinnersGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 24 February 2025