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New treatment option for Ischemic Stroke, Acute
Official title Randomization to Extend Stroke Intravenous ThromboLysis In Evolving Non-Large Vessel Occlusion With TNK (RESILIENT
ClinicalTrials.gov ID: NCT05199662
What this study is testing
What is Intravenous tenecteplase?
Intravenous tenecteplase is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for ischemic stroke, acute.
Also referred to as TNK, Metalyse.
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
- A phase III, randomized, multi-center clinical trial that will examine whether treatment with intravenous TNK is superior to placebo in patients who suffer a non-large vessel occlusion ischemic stroke within 4.5-12 hours from time last seen well. The randomization employs a 1:1 ratio of intravenous thrombolysis with Tenecteplase (TNK) versus placebo in patients who suffer a non-large vessel occlusion ischemic stroke between 4.5 and 12 hours from time last seen well (TLSW) and with a clinical-radiological mismatch or evidence of salvageable brain tissue on perfusion imaging.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Acute ischemic stroke where patient is ineligible for IV thrombolytic treatment with Alteplase due to onset \>4.5 hours and is ineligible for...
- No significant pre-stroke functional disability (mRS ≤2).
- Age ≥18 years (no upper age limit).
- Clinical or imaging mismatch evidence in distal artery territories, defined as one of the following scenarios (A, B or C):
- Scenario A - all of the following:
You likely can't join if
- Intracranial hemorrhage (ICH) identified by CT or MRI.
- Rapidly improving symptoms, particularly if in the judgment of the managing clinician that the improvement is likely to result in the patient without...
- Pre-stroke mRS score of ≥ 2 (indicating previous disability)
- Contra indication to imaging with MR or CT with contrast agents.
- Infarct core \>1/3 MCA territory qualitatively or \>50 mL quantitatively (determined by DWI lesion on MR).
- Participation in any investigational study in the previous 30 days
See the full eligibility criteria
- Acute ischemic stroke where patient is ineligible for IV thrombolytic treatment with Alteplase due to onset \>4.5 hours and is ineligible for endovascular treatment under standard of care due to absence of proximal...
- No significant pre-stroke functional disability (mRS ≤2).
- Age ≥18 years (no upper age limit).
- Clinical or imaging mismatch evidence in distal artery territories, defined as one of the following scenarios (A, B or C):
- Scenario A - all of the following:
- Significant cortical neurological deficit (moderate to severe afasia, moderate to severe heminegligence, severe hemianopsia) with the addition or not of motor symptoms OR any motor deficit accompanied of cortical...
- Contrast-enhanced CT of the head or head MRI with \<50% involvement of the vascular territory corresponding to the clinical manifestation;
- Arterial head angiotomography or arterial head angioMRI WITHOUT proximal intracranial artery occlusion that would require endovascular therapy (for example, ICA intracranial, MCA-M1 and M2 dominant segments and...
- Scenario B - all of the following:
- NIHSS score ≥ 4 due to any neurologic deficits;
- Non-contrast CT of the head or head MRI com \<50% involvement of the vascular territory corresponding to the clinical manifestation;
- Arterial head angioCT or arterial head MRI WITHOUT proximal intracranial artery occlusion that would require endovascular therapy (for example, ICA intracranial, MCA-M1 and M2 dominant segments and vertebral and basilar...
- Arterial head angioCT with distal occlusion on MIP or wedge-shaped lesion on parenchymography on the source-image of angiotomography OR CT perfusion with wedge-shaped cortical lesion.
- Scenario C - all of the following:
- NIHSS score ≥ 4 due to any neurologic deficits;
- The presence of a Target Mismatch defined as:
- Ischemic Core \<50cc (defined on NCCT/CTP\ or DWI MRI) \ Volume NCCT can be used to exclude patients if the investigator believes that its volume assessment is more reliable that the CTP in any particular case.
- Mismatch Volume (Tmax \>6sec lesion - Core volume lesion) \>10cc
- Mismatch Ratio \>1.4
- Patient treatable within 4.5-12 hours of symptom onset. Symptoms onset is defined as point in time the patient was last seen well (at baseline). Treatment start is defined as initiation of IV TNK or placebo infusion.
- Patients who have woken up with the symptoms and don't have a mismatch FLAIR-DWI according to the WAKE-UP Trial image criteria will have their window considered to be \>4.5 hours. In this case, the time last seen well...
- Informed consent obtained from patient or acceptable patient surrogate.
- Intracranial hemorrhage (ICH) identified by CT or MRI.
- Rapidly improving symptoms, particularly if in the judgment of the managing clinician that the improvement is likely to result in the patient without eligibility criteria.
- Pre-stroke mRS score of ≥ 2 (indicating previous disability)
- Contra indication to imaging with MR or CT with contrast agents.
- Infarct core \>1/3 MCA territory qualitatively or \>50 mL quantitatively (determined by DWI lesion on MR).
- Participation in any investigational study in the previous 30 days
- Any terminal illness such that patient would not be expected to survive more than 1 year).
- Baseline platelet count \< 100.000/µL
- Woman of childbearing potential who is known to be pregnant or who has a positive pregnancy test on admission.
- Previous stroke within last three months.
- Recent past history or clinical presentation of ICH, subarachnoid hemorrhage (SAH), arterio-venous (AV) malformation, aneurysm, or cerebral neoplasm other than meningioma.
- Current use of oral anticoagulants and a prolonged prothrombin time (INR \> 1.6).
- Use of heparin, except for low dose subcutaneous heparin, in the previous 48 hours and a prolonged partial thromboplastin time exceeding the upper limit of the local laboratory normal range
- Use of glycoprotein IIb - IIIa inhibitors within the past 72 hours. Use of single agent oral platelet inhibitors (clopidogrel or low-dose aspirin) prior to study entry is permitted.
- Clinically significant hypoglycemia.
- Uncontrolled hypertension defined by a blood pressure \> 185 mmHg systolic or \>110 mmHg diastolic on at least 2 separate occasions at least 10 minutes apart, or requiring aggressive treatment to reduce the blood...
- Hereditary or acquired hemorrhagic diathesis.
- Gastrointestinal or urinary bleeding within the preceding 21 days.
- Major surgery within the preceding 14 days which poses risk in the opinion of the Investigator.
- Exposure to a thrombolytic agent within the previous 72 hours.
- Subject participating in a study involving an investigational drug or device that would impact this study.
The study team makes the final eligibility decision.
Where it's taking place
- Porto Alegre, Rio Grande do Sul, Brazil
- Botucatu, Brazil
- Campinas, Brazil
- Campo Grande, Brazil
- Curitiba, Brazil
- Fortaleza, Brazil
- Joinville, Brazil
- Maceió, Brazil
- Porto Alegre, Brazil
- Ribeirão Preto, Brazil
- São José do Rio Preto, Brazil
- São Paulo, Brazil
- Vitória, Brazil
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Porto Alegre, Rio Grande do Sul, Brazil; Botucatu, Brazil; Campinas, Brazil; Campo Grande, Brazil; Curitiba, Brazil; Fortaleza, Brazil and 7 more location(s). Enter your location above to see the nearest site and check your eligibility.
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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.