Actively Recruiting
Intra-arterial Alteplase for Acute Ischemic Stroke After Mechanical Thrombectomy
Led by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Updated on 2024-09-03
324
Participants Needed
2
Research Sites
121 weeks
Total Duration
On this page
Sponsors
S
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Lead Sponsor
S
Shenzhen Hospital of Southern Medical University
Collaborating Sponsor
AI-Summary
What this Trial Is About
A multicenter, prospective, open-label, blinded endpoint, randomized controlled trial aiming at evaluating the efficacy and safety of intra-arterial recombinant human tissue plasminogen activator (rt-PA) after successful recanalization of acute large vessel occlusion in the anterior circulation by mechanical thrombectomy in improving the 90-day functional outcome.
CONDITIONS
Official Title
Intra-arterial Alteplase for Acute Ischemic Stroke After Mechanical Thrombectomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Clinical diagnosis of acute ischemic stroke
- Time from symptom onset to randomization within 24 hours, including wake-up or no-witness stroke
- Confirmed occlusion of the intracranial internal carotid artery, or M1 or M2 segment of the middle cerebral artery
- Stable eTICI score of 2b50-3 after mechanical thrombectomy, with or without intravenous thrombolysis
- Baseline NIH Stroke Scale score between 6 and 25
- ASPECTS score of 6 or higher on CT or MRI
- Pre-stroke modified Rankin Scale score of 1 or less, or higher if due to non-neurological causes
- Signed informed consent
You will not qualify if you...
- Contraindication to rt-PA except for time to therapy
- Planned dual antiplatelet therapy within 24 hours after thrombectomy
- Carotid artery dissection, severe stenosis, or complete occlusion requiring stents
- Suspected cerebral vasculitis
- Pregnancy or breastfeeding
- Participation in other clinical trials
- Preoperative intracranial hemorrhage
- Known bleeding disorders or anticoagulation factor deficiency
- Coagulation disorder with INR over 1.7 or recent use of new oral anticoagulants
- Platelet count below 50 x 10^9/L
- Suspected infective endocarditis causing vascular occlusion
- Severe kidney problems with low filtration or high creatinine
- Severe allergy to contrast dye or absolute contraindication to iodine contrast
- Suspected aortic dissection
- Recent organ surgery or biopsy within 1 month
- Any active or recent bleeding in the past month
- High blood pressure not controlled by treatment
- Life expectancy under 6 months due to serious illness
- Any condition making the patient unsuitable for study or unable to comply with procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China, 510120
Actively Recruiting
2
Shenzhen Hospital of Southern Medical University
Shenzhen, Guangdong, China
Actively Recruiting
Research Team
X
Xinguang Yang
CONTACT
X
Xiongjun He
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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