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NCT07519889
Observational Study to Assess the Safety of rhTNK-tPA (Mingfule®) vs. Rt-PA (Actilyse®) in Treating Acute Ischemic Stroke
trial testing rhTNK-tPA in Acute Ischemic Stroke in 4,500 participants. Not yet recruiting.
10 January 2027
Quick facts
| Lead sponsor | CSPC Mingfule Pharmaceutical (Guangzhou) Co., Ltd. |
|---|---|
| Status | Not yet recruiting |
| Study type | OBSERVATIONAL |
| Enrollment | 4,500 |
| Start date | 10 April 2026 |
| Primary completion | 10 January 2027 |
| Estimated completion | 10 April 2027 |
Drugs / interventions tested
Conditions studied
- Acute Ischemic Stroke — all drugs for Acute Ischemic Stroke →
- rhTNK-tPA — all drugs for rhTNK-tPA →
Sponsor
CSPC Mingfule Pharmaceutical (Guangzhou) Co., Ltd.
Who can join
18 and older, any sex, with Acute Ischemic Stroke or rhTNK-tPA. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a multicenter, prospective, non-randomized, post-marketing safety surveillance cohort study with rt-PA (Actilyse®) as the control. It is designed to evaluate the safety of intravenous thrombolysis with recombinant human TNK tissue-type plasminogen activator (rhTNK-tPA, Mingfule®) compared with rt-PA (Actilyse®) in patients with acute ischemic stroke in the real-world setting. This is a non-interventional observational study with no randomization. Treatment decisions are made by treating physicians based on routine clinical practice and the patient's condition. Patients are naturally allocated to the rhTNK-tPA group or the rt-PA group according to the actual thrombolytic drug they receive.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07519889
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of rhTNK-tPA
Trials testing the same drug.
- NCT07201688 — Phase III Clinical Trial of rhTNK-tPA in Treating Acute Ischemic Stroke With Extended Time Window. · Phase 3 · recruiting
- NCT06414499 — Teneteplase Reperfusion Therapy in Acute Ischemic Cerebrovascular Events-Ⅳ · Phase 3 · recruiting
- NCT05752916 — Intravenous Thrombolysis With rhTNK-tPA for Acute Non-large Vessel Occlusion in Extended Time Window · Phase 4 · completed
- NCT04733742 — Endovascular Treatment With Versus Without Intravenous rhTNK-tPA in Stroke · Phase 2, PHASE3 · completed
- NCT04588337 — INtravenous TNK for Acute isChemicsTroke in China · completed
Other recruiting trials for Acute Ischemic Stroke
Currently open trials in the same condition.
- NCT07115940 — Medical Management With Endovascular Thrombectomy Versus Medical Management Alone in Patients Presenting Beyond 24 Hours · NA · recruiting
- NCT07404852 — Non-invasive Vagus Nerve Stimulation to Reduce Inflammation and Brain Injury Blood Biomarkers Following an Acute Ischemi · NA · recruiting
- NCT07361302 — A Study to Test if Tenecteplase Helps People to Recover From an Acute Stroke When Given More Than 4.5 Hours After the Pe · Phase 3 · recruiting
- NCT07436156 — SUMMIT RISE Study of Acute Ischemic Stroke Patients · Phase 4 · recruiting
- NCT07203625 — Tenecteplase Before Interhospital Transfer in Acute Basilar Artery Occlusion at 4.5 to 24 Hours · Phase 4 · recruiting
Other CSPC Mingfule Pharmaceutical (Guangzhou) Co., Ltd. trials
Trials by the same sponsor.
- NCT07201688 — Phase III Clinical Trial of rhTNK-tPA in Treating Acute Ischemic Stroke With Extended Time Window. · Phase 3 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07519889 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by CSPC Mingfule Pharmaceutical (Guangzhou) Co., Ltd.
- Last refreshed: 9 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07519889.
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