NCT05657444CompletedPhase 3
Intra-arterial Tenecteplase During First Thrombectomy Attempt for Acute Stroke (BRETIS-TNK II)
Intra-arterial Tenecteplase During First Thrombectomy Attempt for Acute Stroke (BRETIS-TNK II): a Prospective, Randomized, Adaptive Enrichment, Open-label, Blinded End Point, Multi-center Study
Source: ClinicalTrials.gov · Last updated 28 Mar 2025
Brief summary (registry, in English)
A recent pilot study suggests intra-arterial tenecteplase (TNK) during the first pass of endovascular treatment (EVT) seems safe, may increase first-pass reperfusion and good outcome in acute ischemic stroke (AIS) patients with large vessel occlusion (LVO). The study aimed to determine the efficacy and safety of intra-arterial TNK administration during EVT in AIS-LVO patients.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 380 (actual)
- First submitted
- 2 Dec 2022
- Start date
- 21 Mar 2023
- Primary completion date
- 20 Mar 2025
- Lead sponsor
- General Hospital of Shenyang Military Region
- Diseases
- Stroke
- NCT number
- NCT05657444
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 380
- From 21 Mar 2023 to the primary completion date, 20 Mar 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- hemorrhagic stroke;
- Coagulation disorders, systematic hemorrhagic tendency, thrombocytopenia (\<100000/mm3);
- Severe uncontrolled hypertension (systolic blood pressure over 200mmHg or diastolic blood pressure over 110 mmHg);
- Patients with contraindication or allergic to any ingredient of drugs in our study;
- The estimated life expectancy is less than 6 months due to other serious diseases;
- Other conditions unsuitable for this clinical study as assessed by researcher.
Lab values
- Severe hepatic or renal dysfunction, increase in ALT or AST (more than 2 times of upper limit of normal value), elevated serum creatinine (more than 1.5 times of upper limit of normal value) or requiring dialysis;
Other
- Tandem occlusion;
- Pregnancy, or plan to get pregnant or during active lactation;
- Suspected septic embolus or infective endocarditis
Who the study is looking for
- Age ≥18 years;
- Stroke patient with large vessel occlusion (internal carotid artery, M1 or M2 of middle cerebral artery, basilar artery, or intracranial segment of vertebral artery) who meets criteria for endovascular treatment within 24 hours of stroke onset;
- The modified Rankin Scale (mRS) score before onset ≤ 2;
- ASPECTS 6 or greater on CT
- Signed informed consent.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| General Hospital of Northern Theater Command Coordinator of this site? Confirm its status | Shenyang | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.