Extending the Time Window for Intravenous Tenecteplase in Patients With Distal Medium Vessel Occlusions Stroke

NCT06559436 | Recruiting DMC

• 1 other identifier: TNK-MeVO
• Study Type: interventional
• Target: 560
• Locations: 1 country
• Sites: 1

Brief Summary

To assess the safety and efficacy of beyond time window TNK intravenous thrombolysis for distal Medium Vessel Occlusion (MeVO) related stroke in a prospective randomized clinical trial.

Conditions

Acute Ischemic Stroke

Keywords

Medium Vessel Occlusion; Stroke Due To Medium Vessel Occlusion; Beyond optimal time window; TNK intravenous thrombolysis

Outcome Measures

Primary Outcomes (1)

• Rates of 90 day good functional outcomes

  (mRS score ≤ 1 is defined as good prognosis)

  90 (± 14 days) after procedure

Secondary Outcomes (2)

• 2. Proportion of patients with functional independence outcome (mRS 0-2) at day 90

  90 (± 14 days) after procedure

• 3. Proportion of patients with ambulatory and self-care capable outcome (mRS 0-3) at day 90

  90 (± 14 days) after procedure

Other Outcomes (1)

• Symptomatic intracranial hemorrhage (sICH)

  24 hours after procedure

Study Arms (2)

Intravenous thrombolysis

EXPERIMENTAL

Patients in the TNK treatment group will receive TNK intravenous thrombolysis after MeVO is determined, and the usual dosage for TNK intravenous thrombolysis is 0.25mg/Kg, with a maximum of 25mg.

Drug: Intravenous thrombolysis

Standard medical management

ACTIVE COMPARATOR

Standard medical management

Other: Standard medical management

Interventions

Intravenous thrombolysis DRUG

Patients in the TNK treatment group will receive TNK intravenous thrombolysis after MeVO is determined, and the usual dosage for TNK intravenous thrombolysis is 0.25mg/Kg, with a maximum of 25mg,

Intravenous thrombolysis

Standard medical management OTHER

Standard medical management

Standard medical management

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Age ≥18 years;
• Premorbid mRS 0-1;
• Evidence of a disabling stroke defined as follows:
• Baseline National Institutes of Health Stroke Scale (NIHSS) score ≥4 at the time of randomization.
• 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.
• 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.
• Time from onset (or time last seen well) to treatment within 4.5-24 hours;
• Informed consent obtained from patient or acceptable patient surrogate.

You may not qualify if:

• Received intravenous thrombolysis prior to randomization;
• Allergy to Tenecteplase;
• Seizures, or other neurological/mental illness at stroke onset if it precludes obtaining an accurate baseline NIHSS;
• Patients planned to undergo MT or other endovascular treatments (e.g., intra-arterial thrombolysis);
• Systolic blood pressure\>185 mmHg or diastolic blood pressure\>110 mmHg, which cannot be controlled by antihypertensive drug(s);
• Acute intracerebral hemorrhage identified by CT or MRI;
• Clinical presentation suggests a subarachnoid hemorrhage, even if initial CT or MRI scan is normal;
• Subjects with occlusions in multiple vascular territories (e.g., bilateral or multi-territorial anterior circulation, or anterior/posterior circulation);
• Contraindication to imaging with MR or CT with contrast agents;
• 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;
• 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);
• 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;
• 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;
• 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;
• Life expectancy \< 1 year;

Sponsors & Collaborators

• The First Affiliated Hospital of University of Science and Technology of China: lead

Study Sites (1)

The First Affiliated Hospital of University of Science and Technology of China

Hefei, Anhui, China

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Wei Hu, MD, PhD

CONTACT

+86 055162284313; andinghu@ustc.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 14, 2024
• First Posted: August 19, 2024
• Study Start: October 2, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 24, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)