Extending treatment window for stroke patients with medium vessel occlusions

Extending the Time Window for Intravenous Tenecteplase in Patients With Distal Medium Vessel Occlusions Stroke-a Randomised, Controlled, Multicentre Study

This study is testing if giving a clot-busting drug to stroke patients with certain types of blockages after the usual treatment time can help them recover better than standard care.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 560 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: The First Affiliated Hospital of University of Science and Technology of China (other)
• Locations: 1 site (Hefei, Anhui)
• Trial ID: NCT06559436 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the safety and effectiveness of administering intravenous tenecteplase beyond the standard time window for patients suffering from acute ischemic stroke due to distal medium vessel occlusions. The study will involve a prospective randomized design to compare outcomes in patients receiving thrombolysis treatment with those receiving standard medical management. The focus is on patients who have a salvageable penumbra on perfusion imaging and meet specific eligibility criteria related to their stroke severity and vessel occlusion characteristics.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older who have experienced a disabling stroke due to a distal medium vessel occlusion and meet specific clinical criteria.

Not a fit: Patients with strokes caused by proximal vessel occlusions or those who do not meet the defined eligibility criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve recovery outcomes for stroke patients who currently have limited treatment options beyond the standard time frame.

How similar studies have performed: Previous studies have shown that thrombolysis can be effective in acute ischemic stroke patients within certain time frames, but this specific approach for distal medium vessel occlusions is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Evidence of a primary (e.g., not secondary to endovascular therapy of proximal vessel occlusion) distal medium vascular occlusion defined as occlusion of the co/non-dominant M2 segment\*, M3, or M4 segment of the middle cerebral artery (MCA), the anterior cerebral artery (ACA) (A1, A2, A3, or A4 segments), or the posterior cerebral artery (PCA) (P1, P2, P3, or P4 segments);

   \* Co/non-dominant M2 segment vessel diameter should not exceed 2.0 mm. Co-dominant supplying 50% of the MCA territory vs non-dominant supplying \<50% of the MCA territory.
2. Age ≥18 years;
3. Premorbid mRS 0-1;
4. Evidence of a disabling stroke defined as follows:

   1. Baseline National Institutes of Health Stroke Scale (NIHSS) score ≥4 at the time of randomization.
   2. NIHSS 2-3 with disabling deficit including significant aphasia, neglect, hemianopsia, or hemiparesis/ loss of hand or leg function as established by the treating team in context of the patient's life.
5. Less than 50% core in the territory supplied by the occluded vessel as evident by hypodensity and loss of grey-white border on NCCT or ADC \<620 mm2/s on diffusion MRI or rCBF\<30% on CTP after 6h of symptom onset.
6. Time from onset (or time last seen well) to treatment within 4.5-24 hours;
7. Informed consent obtained from patient or acceptable patient surrogate.

Exclusion Criteria:

1. Received intravenous thrombolysis prior to randomization;
2. Allergy to Tenecteplase;
3. Seizures, or other neurological/mental illness at stroke onset if it precludes obtaining an accurate baseline NIHSS;
4. Patients planned to undergo MT or other endovascular treatments (e.g., intra-arterial thrombolysis);
5. Systolic blood pressure\>185 mmHg or diastolic blood pressure\>110 mmHg, which cannot be controlled by antihypertensive drug(s);
6. Acute intracerebral hemorrhage identified by CT or MRI;
7. Clinical presentation suggests a subarachnoid hemorrhage, even if initial CT or MRI scan is normal;
8. Subjects with occlusions in multiple vascular territories (e.g., bilateral or multi-territorial anterior circulation, or anterior/posterior circulation);
9. Contraindication to imaging with MR or CT with contrast agents;
10. Known genetic or acquired bleeding diathesis, or received warfarin and INR \> 1.7; or treated with direct oral anticoagulant agents in the prior 48 hours;
11. Platelets \<100×109/L, APTT \> 40 s, or PT \>15 s; Blood glucose \<50 mg/dl (2.7 mmol/L) or \>400 mg/dl (22.2 mmol/L);
12. Severe renal failure, defined as serum creatinine \> 3.0 mg/dl (or 265.2 μmol/l) or glomerular filtration rate (GFR) \< 30, or patients requiring hemodialysis or peritoneal dialysis;
13. Active internal hemorrhage or at high risk of bleeding, e.g., major surgery, sever trauma or gastrointestinal or urinary tract hemorrhage within the last 2 weeks, or arterial puncture at a non-compressible site within the previous 7 days;
14. Ischemic stroke or myocardial infarction in previous 3 months, previous intracranial hemorrhage, severe traumatic brain injury or intracranial or intraspinal operation in previous 3 months, or known intracranial neoplasm, arteriovenous malformation or giant aneurysm;
15. Life expectancy \< 1 year;
16. Patients who cannot adhere to the trial protocol or follow-up;
17. Currently participating in other clinical trials;
18. Pregnant or lactating women;
19. Any other condition that, in the opinion of the investigator, could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study.

Where this trial is running

Hefei, Anhui

• The First Affiliated Hospital of University of Science and Technology of China — Hefei, Anhui, China (RECRUITING)

Study contacts

• Study coordinator: Wei Hu, MD, PhD

Conditions: Acute Ischemic Stroke, Medium Vessel Occlusion, Stroke Due To Medium Vessel Occlusion, Beyond optimal time window, TNK intravenous thrombolysis