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NCT06010628
Tenecteplase for Acute Ischemic Stroke Within 4.5 to 6 Hours of Onset (EXIT-BT2)
Phase 4 trial testing Tenecteplase in Stroke, Ischemic in 1,440 participants. Currently enrolling.
15 December 2026
Quick facts
| Lead sponsor | General Hospital of Shenyang Military Region |
|---|---|
| Phase | Phase 4 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 1,440 |
| Start date | 1 February 2024 |
| Primary completion | 15 December 2026 |
| Estimated completion | 15 December 2026 |
| Sites | 2 locations across China |
Drugs / interventions tested
- Tenecteplase (TENECTEPLASE) — full drug profile →
Conditions studied
- Stroke, Ischemic — all drugs for Stroke, Ischemic →
Sponsor
General Hospital of Shenyang Military Region
Who can join
18 and older, any sex, with Stroke, Ischemic. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
To date, the benefit of intravenous thrombolysis is confined within 4.5 hours of onset for acute ischemic stroke (AIS) patients without advanced neuroimaging selection. Unpublished pilot EXIT-BT (EXtending the tIme window of Thrombolysis by ButylphThalide up to 6 Hours after onset) suggest the safety, feasibility and potential benefit of intravenous tenecteplase (TNK) in AIS within 4.5 to 6 hours of onset. The current study aims to investigate the efficacy and safety of TNK for AIS within 4.5 to 6 hours of onset.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
A narrative review of reperfusion therapy in acute ischemic stroke: Emerging advances, current challenges, and future directions.
Wang Q, Liu N, Simo L, Ma Q, et al · · 2025 · cited 3× · PMID 40842448 · DOI 10.4103/bc.bc_161_24 -
Intravenous tenecteplase for acute ischemic stroke between 4.5 and 6 h of onset (EXIT-BT2): Rationale and Design.
Wang YH, Guo ZN, Chen MR, Yao ZG, et al · · 2025 · cited 2× · PMID 38859581 · DOI 10.1177/23969873241258058 -
Tailored Treatment of Acute Ischemic Stroke: A Narrative Review of Evidence-Based Strategies by Imaging Type and Thrombectomy Availability.
Kargiotis O, Psychogios K, Safouris A, Chroni E, et al · · 2025 · cited 1× · PMID 41011091 · DOI 10.3390/medicina61091700
Verify or expand the search:
- PubMed search for NCT06010628
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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
- NCT07375966 — Repeated Intravenous Thrombolysis for Ischemic Stroke With Medium to Large Vessel Occlusion Presenting Within 4.5 Hours · 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
Other recruiting trials for Stroke, Ischemic
Currently open trials in the same condition.
- NCT07456956 — HIIT vs MCIT for Stroke-Related Sarcopenia in Ischemic Stroke · NA · recruiting
- NCT06658197 — Efficacy and Safety of Tenecteplase Bridging Mechanical Thrombectomy for Acute Large Vessel Occlusion Stroke · Phase 3 · recruiting
- NCT07282041 — Role of GLP1 RA Dulaglutide on Severe Intracranial Atherosclerosis · Phase 2, PHASE3 · recruiting
- NCT07135089 — Improving Neuroprotective Strategy for Ischemic Stroke Before Endovascular Thrombectomy by Intravenous Tirofiban · Phase 3 · recruiting
- NCT07047014 — Advancing Reperfusion Therapy for Ischemic Stroke (ARTS): Tenecteplase in Medium Vessel Occlusion (MeVO) for Acute Ische · Phase 3 · 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
- NCT07375966 — Repeated Intravenous Thrombolysis for Ischemic Stroke With Medium to Large Vessel Occlusion Presenting Within 4.5 Hours · Phase 2 · recruiting
- NCT07462546 — Transcranial Doppler for Internal Carotid Artery Stenting (TCD-ICAS) · NA · recruiting
- NCT07294885 — Deep Cervical LymphatIc-Venous Anastomosis for Alzheimer's Disease · NA · recruiting
- NCT07412249 — Remote Ischemic Conditioning Plus Stenting for Symptomatic Carotid Artery Stenosis · NA · 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 NCT06010628 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- 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: 21 August 2025
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/NCT06010628.
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