A Phase 4 interventional study of Recombinant Human tenecteplase Tissue-type Plasminogen Activator (rhTNK-tPA) and Best Medical Management in Ischemic Stroke, Acute, sponsored by Beijing Tiantan Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-19.
Sponsored by Beijing Tiantan Hospital · Phase 4, Interventional, and Treatment
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.
2,593 studies on the registry are indexed under Ischemic Stroke; 930 are open to participants now.
This study's planned enrollment of 256 is above the median of 120 across 1,752 interventional studies indexed under Ischemic Stroke.
Browse Ischemic Stroke studies →Beijing Tiantan Hospital is the lead sponsor of 465 studies on the registry; 282 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Clinical Inclusion Criteria:
Neuroimaging Inclusion Criteria:
Exclusion Criteria:
Clinical Exclusion Criteria:
Specific Neuroimaging Exclusion Criteria
Patients of this group will receive IA rhTNK-tPA plus Best Medical Management (BMM) after successful mechanical thrombectomy (MT) recanalization
Drug: Recombinant Human tenecteplase Tissue-type Plasminogen Activator (rhTNK-tPA) · Other: Best Medical Management
Patients of this group will receive Best Medical Management (BMM) alone after successful mechanical thrombectomy (MT) recanalization
Other: Best Medical Management
The administration of rhTNK-tPA will be infused constant and slowly over 15min (0.125 mg/kg, Max 12.5mg) through a microcatheter.
Also known as: IA rhTNK-tPA
Best Medical Management
Rate of excellent outcome
Rate of 90 (±7) day modified Rankin scale (mRS) 0-1
Time frame: 90±7 days after randomization
Rate of sICH (Heidelberg Bleeding Classification)
Rate of sICH (Heidelberg Bleeding Classification)
Time frame: within 48 hours after randomization
Volume of Tmax>6s
Time frame: 24 hours (±12 hours) after randomization
Infarct core volume change from baseline
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)
Time frame: 7 days (±1 day) after randomization/at discharge or at 36 hours (±12 hours) after randomization
mRS (shift analysis)
mRS (shift analysis)
Time frame: 90 days (±7 days) after randomization
Rate of good outcome
Rate of mRS 0-2
Time frame: 90 days (±7 days) after randomization
Rate of mRS 0-3
Rate of mRS 0-3
Time frame: 90 days (±7 days) after randomization
NIHSS 0-1 or decrease ≥10 from baseline NIHSS
NIHSS 0-1 or decrease ≥10 from baseline NIHSS
Time frame: 36 hours (±12hours) after randomization
EQ-5D-5L score
EQ-5D-5L score
Time frame: 90 days (±7 days) after randomization
All-caused mortality
All-caused mortality
Time frame: 90 days (±7 days) after randomization
Rate of any intracranial hemorrhage (Heidelberg Bleeding Classification)
Rate of any intracranial hemorrhage (Heidelberg Bleeding Classification)
Time frame: within 48 hours after randomization
Plan to share: Yes
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Beijing Tiantan Hospital