Intra-Arterial Tenecteplase for Stroke
(INTIMA-MT Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a drug called tenecteplase to determine if it can improve blood flow in individuals who have experienced a specific type of stroke caused by a blockage in a large brain blood vessel. After doctors use a standard procedure to clear the blockage, the drug is administered to assess its effect on improving flow in smaller blood vessels. The trial seeks participants who have experienced a sudden stroke affecting the brain's main arteries and have undergone a clot removal procedure within 24 hours of stroke onset. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant medical advancements.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop all current medications, but you cannot participate if you've used certain blood thinners like dabigatran, rivaroxaban, apixaban, or edoxaban in the last 48 hours, or if you've had thrombolytic treatment in the last 3 months.
Is there any evidence suggesting that intra-arterial tenecteplase is likely to be safe for humans?
Research has shown that intra-arterial tenecteplase is usually well-tolerated. Studies have found it can be safely used in patients who have had a stroke caused by a blockage in a large blood vessel. One study examined the safety of tenecteplase and identified the main concern as the risk of bleeding in the brain, though this was uncommon. Another study found that patients rarely experienced serious side effects, such as a significant worsening of their stroke symptoms.
This treatment is currently undergoing testing in a Phase 2 trial. This phase indicates some early evidence of safety, but further research is needed to fully understand its safety profile. So far, the data appears promising for those considering joining a clinical trial.12345Why do researchers think this study treatment might be promising?
Unlike the standard stroke treatments that primarily rely on systemic administration of clot-busting drugs like alteplase, tenecteplase in this trial is administered intra-arterially. This direct delivery method targets the clot more precisely, potentially increasing effectiveness and reducing the risk of bleeding complications. Researchers are excited about tenecteplase because it can be administered more quickly and efficiently during critical moments of stroke intervention, which might improve patient outcomes significantly.
What evidence suggests that intra-arterial tenecteplase is effective for stroke?
Research has shown that tenecteplase, administered intra-arterially to participants in this trial, may help treat strokes caused by blocked blood flow to the brain, known as acute ischemic strokes. One study found that 37% of patients who received tenecteplase had excellent recovery results, compared to 36% of those treated with another common medication, alteplase. Another study found that tenecteplase restored blood flow more effectively in some patients. Additionally, evidence suggests that tenecteplase can lead to better recovery when used after a procedure that removes large blockages in blood vessels. These findings indicate that tenecteplase might improve blood flow and recovery after a stroke.36789
Who Is on the Research Team?
Christopher Favilla, MD
Principal Investigator
University of Pennsylvania
Are You a Good Fit for This Trial?
This trial is for acute ischemic stroke patients who have had a large vessel blockage in the brain cleared but might still have small blood clots. They must be treated within 24 hours of their stroke, show certain patterns on imaging tests, and score above a threshold on a neurological scale. People can't join if they don't agree to the study rules or can't follow them.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Patients receive a single dose of intra-arterial tenecteplase after successful large vessel recanalization
Post-Treatment Monitoring
Post-treatment clinical monitoring and imaging to assess recanalization, reperfusion, and safety
Follow-up
Participants are monitored for safety and effectiveness after treatment, with functional outcomes assessed at 90 days
What Are the Treatments Tested in This Trial?
Interventions
- Tenecteplase
Trial Overview
The study is testing whether injecting tenecteplase directly into arteries after mechanical clot removal improves blood flow in tiny vessels in the brain. Patients' blood flow will be measured before and after this treatment using special imaging techniques.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Patients will receive a single dose of tenecteplase, administered intra-arterially after successful large vessel recanalization. The treatment will be administered via intra-arterial catheter in the distal M1 segment of the middle cerebral artery (distal to lenticulostriates).
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Pennsylvania
Lead Sponsor
Genentech, Inc.
Industry Sponsor
Ashley Magargee
Genentech, Inc.
Chief Executive Officer since 2024
MBA from Harvard University, BA from Princeton University
Levi Garraway
Genentech, Inc.
Chief Medical Officer since 2021
MD, PhD
Citations
Intra-arterial Tenecteplase for Acute Stroke After ...
Main outcomes and measures: The primary end point was excellent outcome at 90 days, defined as modified Rankin Scale (mRS) score of 0 to 1 ( ...
Tenecteplase for Acute Ischemic Stroke at 4.5 to 24 Hours
The primary outcome was excellent functional outcome (modified Rankin Scale score, 0–1) at 90 days, with additional efficacy and safety end ...
TNKase® (tenecteplase) | Efficacy in Acute Ischemic Stroke
37% of TNKase-treated patients had excellent functional outcomes (defined as mRS 0-1) 90 to 120 days following a stroke vs ~36% for alteplase.
Intra-Arterial Tenecteplase After Successful Reperfusion in ...
This phase 1 and 2 randomized clinical trial investigated both the safety threshold and efficacy of 3 different doses of tenecteplase when ...
Occlusion site and outcomes in intra-arterial tenecteplase ...
Post hoc analysis showed higher eTICI progression in ICA patients (51.5%) versus MCA M1 (37.9%) and M2 (25.7%). IA tenecteplase had a lower any ...
Intra-Arterial Tenecteplase After Successful Reperfusion in ...
This phase 1 and 2 randomized clinical trial investigated both the safety threshold and efficacy of 3 different doses of tenecteplase when ...
Intra-Arterial Tenecteplase After Reperfusion for Large ...
This randomized clinical trial assesses the effect of adjunctive intra-arterial tenecteplase on freedom from disability at 90 days in ...
Safety of Adjunctive Intraarterial Tenecteplase Following ...
The primary safety end point was any intracranial hemorrhage and neurological worsening by ≥4 points on the National Institutes of Health Stroke ...
Intra-arterial tenecteplase is safe and may improve the first- ...
This is the first study to report that intra-arterial TNK during the first pass of EVT seems safe and feasible in AIS-LVO patients.
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