At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,430 enrolled
Drug / intervention
rt-PA +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3, Multicentre,Open-label, Randomised Controlled, Non-inferiority Trial
In Brief
A Phase 3 clinical trial evaluating rt-PA and rhTNK-tPA for Acute Ischemic Stroke. Completed, enrolled 1,430 participants across 61 sites.
Detailed Summary
A Phase Ⅲ, Multicenter, Prospective, Randomized, Open Label, Blinded-endpoint (PROBE) Controlled Trial of Recombinant Human TNK Tissue-type Plasminogen Activator (rhTNK-tPA) for Injection Versus Alteplase for Acute Ischemic Stroke Within 4.5 Hours
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Ischemic Stroke
CountriesChina
CollaboratorsCSPC Mingfule Pharmaceutical (Guangzhou) Co., Ltd.
Timeline
Phase 3CompletedFinished
20222023202420252026
First PostedMar 2021
Enrollment StartJun 2021
Primary CompletionMay 2022
Study CompletionJul 2022
TodayJul 2026
First PostedMar 15, 2021
Enrollment StartJun 12, 2021
Primary CompletionMay 29, 2022
Study CompletionJul 15, 2022
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 5.3 years ago
Interventions
rt-PAdrug
Subjects will be randomized to rhTNK-tPA or rt-PA in a 1:1 ratio.
rhTNK-tPAdrug
Subjects will be randomized to rhTNK-tPA or rt-PA in a 1:1 ratio.