BridgeMD
New treatment option for Ischemic Stroke
Official title Repeated Intravenous Thrombolysis for Ischemic Stroke With Medium to Large Vessel Occlusion Presenting Within 4.5 Hours of Onset With Tenecteplase (RITIS-TNK2)
ClinicalTrials.gov ID: NCT07375966
What this study is testing
What is Tenecteplase?
Tenecteplase is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for ischemic stroke.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Age ≥ 18 year;
- Acute ischemic stroke presumably caused by large or medium vessel occlusion within 4.5 hours of onset, having received standard-dose intravenous...
- Measurable neurological deficit before the first intravenous thrombolysis, with NIHSS ≥ 4;
- Baseline pc-ASPECTS/ASPECTS ≥ 6, and for posterior circulation infarction, a Pontine-Midbrain Index ≤ 2 (assessed by CT or DWI);
- No significant clinical improvement (reduction in NIHSS ≤ 2) or neurological deterioration after initial improvement at 1 hour after the first...
You likely can't join if
- Planed for endovascular treatment;
- Significant white matter hyperintensities (Fazekas score 3);
- Any coagulation abnormality before the first thrombolysis, including INR \> 1.5;
- Receipt of dual antiplatelet therapy within 24 hours prior to thrombolysis.；
- Pregnancy；
- Allergy to the investigational drug(s)；
See the full eligibility criteria
- Age ≥ 18 year;
- Acute ischemic stroke presumably caused by large or medium vessel occlusion within 4.5 hours of onset, having received standard-dose intravenous thrombolysis, and with no planned thrombectomy;
- Measurable neurological deficit before the first intravenous thrombolysis, with NIHSS ≥ 4;
- Baseline pc-ASPECTS/ASPECTS ≥ 6, and for posterior circulation infarction, a Pontine-Midbrain Index ≤ 2 (assessed by CT or DWI);
- No significant clinical improvement (reduction in NIHSS ≤ 2) or neurological deterioration after initial improvement at 1 hour after the first thrombolysis;
- Follow-up imaging (CTA or MRA) at 1 hour after the first thrombolysis rules out intracranial hemorrhage and confirms the presence of large or medium vessel occlusion (internal carotid artery, M1-M3 segments of the...
- The second intravenous thrombolysis can be administered within 6 hours of onset;
- First stroke onset or past stroke without obvious neurological deficit (mRS≤1);
- Signed informed consent.
- Planed for endovascular treatment;
- Significant white matter hyperintensities (Fazekas score 3);
- Any coagulation abnormality before the first thrombolysis, including INR \> 1.5;
- Receipt of dual antiplatelet therapy within 24 hours prior to thrombolysis.；
- Pregnancy；
- Allergy to the investigational drug(s)；
- Comorbidity with other serious diseases;
- Participating in other clinical trials within 3 months;
- Patients not suitable for the study considered by researcher.
The study team makes the final eligibility decision.
Where it's taking place
- Shenyang, Liaoning, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shenyang, Liaoning, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.