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NCT07375966: RITIS-TNK2
Repeated Intravenous Thrombolysis for Ischemic Stroke With Medium to Large Vessel Occlusion Presenting Within 4.5 Hours of Onset With Tenecteplase (RITIS-TNK2)
Phase 2 trial testing Tenecteplase in Ischemic Stroke in 198 participants. Currently enrolling.
30 December 2027
Quick facts
| Lead sponsor | General Hospital of Shenyang Military Region |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 198 |
| Start date | 25 March 2026 |
| Primary completion | 30 December 2027 |
| Estimated completion | 30 December 2027 |
| Sites | 1 location across China |
Drugs / interventions tested
- Tenecteplase (TENECTEPLASE) — full drug profile →
Conditions studied
- Ischemic Stroke — all drugs for Ischemic Stroke →
Sponsor
General Hospital of Shenyang Military Region
Who can join
Adults 18 to 80, any sex, with Ischemic Stroke. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
While intravenous thrombolysis (IVT) within 4.5 hours is the standard medical reperfusion therapy, its efficacy is limited, particularly for large or medium vessel occlusions (LVO/MeVO), with low recanalization rates for IVT with rt-PA. The newer thrombolytic agent, tenecteplase (TNK), offers practical advantages-including single bolus administration, a longer half-life, and potentially higher fibrin specificity-and has been shown to be non-inferior to rt-PA. Despite advances, a significant proportion of patients with LVO/MeVO do not achieve early clinical improvement after standard IVT, likely due to persistent occlusion from a high thrombus burden. Endovascular therapy, while highly effective for LVO, has limited accessibility. Therefore, there is an urgent need for more effective and widely accessible pharmacological strategies. This study proposes a rescue strategy based on the hypothesis that a second dose of IVT may improve outcomes in patients with imaging-confirmed LVO or MeVO who show no significant neurological improvement one hour after standard TNK thrombolysis (administered within 4.5 hours of stroke onset). The primary aim of this study is to formally evaluate the efficacy and safety of a repeated dose of intravenous tenecteplase in this specific patient population.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Related trials
Other trials of Tenecteplase
Trials testing the same drug.
- NCT07375953 — Repeated Intravenous Thrombolysis for Ischemic Stroke Within 3.0 Hours of Onset With Tenecteplase (RITIS-TNK) · Phase 2 · 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
- NCT06658197 — Efficacy and Safety of Tenecteplase Bridging Mechanical Thrombectomy for Acute Large Vessel Occlusion Stroke · Phase 3 · recruiting
- NCT06621121 — A Real-world Study of Tenecteplase Versus Alteplase for Thrombolysis in Patients Within 4.5 H of Onset of Ischemic Strok · recruiting
- NCT06320431 — ACT-GLOBAL THROMBOLYSIS (ACT-WHEN-001) Domain Within the ACT-GLOBAL Adaptive Platform Trial-NCT06352632 · Phase 3 · recruiting
Other recruiting trials for Ischemic Stroke
Currently open trials in the same condition.
- NCT07509645 — Efficacy and Safety of Interleukin-6 Receptor Inhibitor Combined With Endovascular Treatment in Patients With Acute Post · Phase 3 · recruiting
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- NCT07491952 — Continuous Dual Aspiration Technique With Zoom System for Stroke · recruiting
- NCT07371455 — A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LWP779 in Healthy Participants · Phase 1 · recruiting
- NCT07414732 — Testing the Effectiveness of a Novel Intervention to Improve Medication Adherence in Stroke Survivors · NA · recruiting
Other General Hospital of Shenyang Military Region trials
Trials by the same sponsor.
- NCT07375953 — Repeated Intravenous Thrombolysis for Ischemic Stroke Within 3.0 Hours of Onset With Tenecteplase (RITIS-TNK) · Phase 2 · recruiting
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- NCT07283159 — Tenecteplase Plus Urinary Kallidinogenase for Acute Ischemic Stroke (TUKIS) · Phase 2 · 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 NCT07375966 (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 General Hospital of Shenyang Military Region
- Last refreshed: 1 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/NCT07375966.
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