Actively Recruiting
Tenecteplase for Intravenous Stroke Thrombolysis in Recent DOAC Users
Led by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Updated on 2025-12-16
912
Participants Needed
1
Research Sites
176 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
An investigator-initiated, multicenter, randomized, placebo-controlled, double-blind trial to determine the efficacy and safety of intravenous tenecteplase thrombolysis in acute ischemic stroke (AIS) patients with recent direct oral anticoagulants (DOACs) intake in improving the 90-day functional outcome.
CONDITIONS
Official Title
Tenecteplase for Intravenous Stroke Thrombolysis in Recent DOAC Users
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Clinically diagnosed with acute ischemic stroke
- DOACs intake within 48 hours prior to enrollment or ongoing DOAC therapy with unknown last intake time
- Study intervention can start within 4.5 hours of last known well or within 4.5 to 24 hours with evidence of target mismatch on imaging
- Baseline NIHSS score of 4-25, or disabling stroke with NIHSS 0-3 including specific neurological deficits
- Written informed consent provided by patient or legally authorized representative
You will not qualify if you...
- Intracranial or subarachnoid hemorrhage confirmed by CT or MRI, or history of intracranial hemorrhage
- Allergy to tenecteplase
- Pre-stroke modified Rankin Scale score of 3 or higher
- Planned endovascular treatment
- On dual antiplatelet therapy along with DOAC therapy
- Planned DOAC reversal treatment
- Hypodensity affecting one-third or more of the middle cerebral artery territory on CT
- Severe head or other trauma within the last 3 months
- Intracranial tumor, arteriovenous malformation, or large aneurysm (10 mm or larger)
- Major intracranial, intraspinal, or other surgery within 3 months
- Gastrointestinal or urinary system bleeding within the past 3 weeks
- Active visceral bleeding
- Aortic arch dissection or infective endocarditis
- Platelet count below 100 x 10^9/L
- Received heparin or low-molecular-weight heparin within 24 hours
- Pregnant or breastfeeding women
- Blood glucose below 50 mg/dl or above 400 mg/dl at screening
- Uncontrolled high blood pressure despite treatment
- Life expectancy under 6 months due to serious illness
- Participation in other clinical trials
- Other conditions making study participation unsuitable, including mental illness or cognitive disorders
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China, 510000
Actively Recruiting
Research Team
Y
Yanting Chen
CONTACT
X
Xinguang Yang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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