Recruiting PHASE3 INTERVENTIONAL 2-arm NCT07201688

Phase III Clinical Trial of rhTNK-tPA in Treating Acute Ischemic Stroke With Extended Time Window. (TRACE-LATE)

Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Trial of Recombinant Human TNK Tissue-Type Plasminogen Activator for Injection (rhTNK-tPA, Mingfule) in Intravenous Thrombolysis for Acute Ischemic Stroke With Extended Time Window (4.5-24 Hours After Onset).

Sponsor: CSPC Mingfule Pharmaceutical (Guangzhou) Co., Ltd.

Conditions Acute Ischemic Stroke

Interventions Placebo rhTNK-tPA

Updated 2 times since 2025 Last updated: Dec 8, 2025 Started: Nov 30, 2025 Primary completion: Sep 30, 2027 Completion: Sep 30, 2027

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT07201688, this PHASE3 trial focuses on Acute Ischemic Stroke and remains actively recruiting participants. Sponsored by CSPC Mingfule Pharmaceutical (Guangzhou) Co., Ltd., it has been updated 2 times since 2025, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

Change History

2 versions recorded

Jan 2026 — Present [monthly]

Recruiting PHASE3

Status: Not Yet Recruiting → Recruiting
Nov 2025 — Jan 2026 [monthly]

Not Yet Recruiting PHASE3

First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

CSPC Mingfule Pharmaceutical (Guangzhou) Co., Ltd.

Data source: CSPC Mingfule Pharmaceutical (Guangzhou) Co., Ltd.

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

• Puyang, China