Ischemic Stroke, Acute
Conditions
Brief summary
The goal of this clinical trial is to evaluate whether intra-arterial (IA) rhTNK-tPA thrombolysis can improve neurological outcomes in acute large vessel occlusion patients after successful mechanical thrombectomy (MT) recanalization between 4.5- 24 hours from symptom onset. Participants enrolled will be randomly assigned to study or control arm with a 1:1ratio. Study group will receive IA rhTNK-tPA thrombolysis (0.125 mg/kg, Max 12.5mg) plus best medical management, and control receive best medical management alone.
Interventions
DRUGRecombinant Human tenecteplase Tissue-type Plasminogen Activator (rhTNK-tPA)
The administration of rhTNK-tPA will be infused constant and slowly over 15min (0.125 mg/kg, Max 12.5mg) through a microcatheter.
Best Medical Management
Sponsors
Beijing Tiantan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Clinical Inclusion Criteria: 1. Age \>18 years; 2. NIHSS ≥2; 3. Onset of symptoms to baseline CT imaging time: 4.5 to 24 hours, including wake-up stroke and unwitnessed stroke; Time of onset of symptoms is defined as last known well (LKW); 4. Pre-stroke mRS score 0-1; 5. Signed informed consent from patient or their health care proxy. Neuroimaging Inclusion Criteria: 1. CTA/MRA proven intracranial artery occlusion: Intracranial Internal Carotid Artery (ICA)、M1 of Middle cerebral artery (MCA)、dominant M2 of MCA; 2. ASPECTS ≥6 on non-contrast CT (NCCT) scan or DWI MRI; 3. CT perfusion or MR perfusion: ischemic infarct core \<70ml, mismatch ratio≥1.2, mismatch volume ≥15ml; 4. Treated with MT resulting in an eTICI score 2b50-3 at end of the procedure. Patients with an eTICI score 2b50-3 on the diagnostic cerebral angiography before the onset of MT are also eligible for the study.
Exclusion criteria
Clinical
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of excellent outcome | 90±7 days after randomization | Rate of 90 (±7) day modified Rankin scale (mRS) 0-1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Volume of Tmax>6s | 24 hours (±12 hours) after randomization | — |
| Infarct core volume change from baseline | 7 days (±1 day) after randomization/at discharge or at 36 hours (±12 hours) after randomization | Infarct core volume change from baseline, assessed with NCCT at 7 days (±1 day) after randomization/at discharge or with MRI at 36 hours (±12 hours) |
| mRS (shift analysis) | 90 days (±7 days) after randomization | mRS (shift analysis) |
| Rate of good outcome | 90 days (±7 days) after randomization | Rate of mRS 0-2 |
| Rate of sICH (Heidelberg Bleeding Classification) | within 48 hours after randomization | Rate of sICH (Heidelberg Bleeding Classification) |
| NIHSS 0-1 or decrease ≥10 from baseline NIHSS | 36 hours (±12hours) after randomization | NIHSS 0-1 or decrease ≥10 from baseline NIHSS |
| EQ-5D-5L score | 90 days (±7 days) after randomization | EQ-5D-5L score |
| All-caused mortality | 90 days (±7 days) after randomization | All-caused mortality |
| Rate of any intracranial hemorrhage (Heidelberg Bleeding Classification) | within 48 hours after randomization | Rate of any intracranial hemorrhage (Heidelberg Bleeding Classification) |
| Rate of mRS 0-3 | 90 days (±7 days) after randomization | Rate of mRS 0-3 |
Countries
China
Contacts
Primary ContactXiaochuan Huo, Dr.
Outcome results
None listed