NCT06987305 Intravenous rhTNK-tPA Before Stroke Thrombectomy in the Extended Time Window
| NCT ID | NCT06987305 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Xinqiao Hospital of Chongqing |
| Condition | Stroke, Acute Ischemic |
| Study Type | INTERVENTIONAL |
| Enrollment | 820 participants |
| Start Date | 2025-10-21 |
| Primary Completion | 2027-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 820 participants in total. It began in 2025-10-21 with a primary completion date of 2027-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This randomized, double-blind, placebo-controlled phase III clinical trial aims to evaluate the efficacy and safety of intravenous recombinant human tenecteplase (rhTNK-tPA) in acute ischemic stroke patients with large vessel occlusion presenting 4.5-24 hours after last known well. The study will address two primary questions: 1) Whether rhTNK-tPA enhances pre-thrombectomy reperfusion rates and improves 90-day functional outcomes compared to placebo; 2) Whether rhTNK-tPA increases the risk of symptomatic intracranial hemorrhage and mortality. Participants will be randomized to receive either a single bolus of rhTNK-tPA (0.25 mg/kg, max 25 mg) or matching placebo administered intravenously over 5 seconds. Key assessments include repeat neuroimaging (CT/CTA or MRI/MRA) at 24 hours post-treatment to evaluate reperfusion, NIH Stroke Scale score at day 5-7, and modified Rankin Scale score assessment at 90 days. Safety monitoring will focus on hemorrhagic transformation and mortality events throughout the study period.
Eligibility Criteria
Inclusion Criteria: 1. Age ≥18 years; 2. Acute ischemic stroke presenting within 4.5-24 hours of last known well; 3. No significant pre-stroke functional disability: for age \<80 years, pre-stroke modified Rankin scale (mRS) ≤2; for age ≥80 years, prestroke mRS ≤1; 4. Baseline NIHSS score ≥5; 5. Imaging criteria of BOTH: 1. Occlusion on CTA/MRA in one of the following vessels: M1/M2 segment of middle cerebral artery, A1 segment of anterior cerebral artery, V4 segment of vertebral artery, basilar artery, or P1 segment of posterior cerebral artery. For A1, or P1 occlusions, vessel diameter must be ≥0.75 mm; 2. For anterior circulation occlusion: CTP/MRP demonstrating mismatch ratio ≥1.8, absolute mismatch volume ≥15 mL, and ischemic core volume \<70 mL; OR have a mismatch between the presence of an abnormal signal on MRI diffusion-weighted imaging and no visible signal change on FLAIR. For posterior circulation occlusion: pc-ASPECTS score ≥6. 6. Plan to received endovascular thrombectomy; 7. The patient or their legal representative provides written informed consent. Exclusion Criteria: 1. Intracranial hemorrhage confirmed by CT/MRI; 2. Already received intravenous thrombolytic after index stroke.; 3. Pregnancy or lactation; 4. Concurrent participation in other investigation drug clinical trials; 5. Arterial tortuosity or other vascular anomalies precluding endovascular access to target vessel; 6. Pre-existing neurological/psychiatric disorders interfering with neurological assessment; 7. Space-occupying intracranial tumors (except small meningiomas ≤3 cm); 8. Intracranial aneurysm or arteriovenous malformation; 9. Terminal illness with life expectancy \<6 months; 10. Anticipated inability to complete follow-up assessments.
Contact & Investigator
Qingwu Yang, MD
PRINCIPAL INVESTIGATOR
Department of Neurology, Xinqiao Hospital of the Army Medical University
Frequently Asked Questions
Who can join the NCT06987305 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Stroke, Acute Ischemic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06987305 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 820 participants.
Is NCT06987305 currently recruiting?
Yes, NCT06987305 is actively recruiting participants. Contact the research team at qiuzhongmingdoctor@163.com for enrollment information.
Where is the NCT06987305 trial being conducted?
This trial is being conducted at Wuhan, China, Xiangtan, China, Jiujiang, China, Nanchang, China.
Who is sponsoring the NCT06987305 clinical trial?
NCT06987305 is sponsored by Xinqiao Hospital of Chongqing. The principal investigator is Qingwu Yang, MD at Department of Neurology, Xinqiao Hospital of the Army Medical University. The trial plans to enroll 820 participants.
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