Tenecteplase Reperfusion Therapy in Acute Ischemic Cerebrovascular Events-BEYOND

NCT06954155 | Recruiting Phase 3 DMC

• 1 other identifier: CSA2024YJ007
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 1

Brief Summary

The benefit-risk profile of thrombolysis for acute ischemic strokes beyond 24 hours has never been investigated. We initiated a multicenter, prospective, randomized, open label, blinded-endpoint (PROBE) controlled trial to assess the safety and efficacy of tenecteplase (0.25mg/kg, max 25mg) versus standard medical treatment in acute ischemic stroke due to intracranial vessel occlusion between 24-72 hours of symptom onset (including wake-up stroke and unwitnessed stroke).

Conditions

Stroke

Keywords

ischemic stroke; tenecteplase; beyond 24 hours

Outcome Measures

Primary Outcomes (1)

• mRS score ≤ 1 at 90 days

  The proportion of patients with an mRS score ≤ 1 at 90 days

  90 days

Secondary Outcomes (8)

• mRS score

  90 days

• mRS score ≤ 2 at 90 days

  90 days

• early neurological improvement at 24h after randomization

  24 hours

• improvement on reperfusion at 24h after randomization (anterior circulation)

  24 hours

• complete recanalization at 24h after randomization

  24 hours

Study Arms (2)

Tenecteplase (0.25 mg/kg)

EXPERIMENTAL

Tenecteplase (0.25 mg/kg, max 25 mg)

Drug: Tenecteplase (0.25mg/kg)

Standard medical treatment

ACTIVE COMPARATOR

Aspirin combined with clopidogrel, aspirin alone, or clopidogrel alone, etc.

Drug: Standard medical treatment

Interventions

Tenecteplase (0.25mg/kg) DRUG

Each vial of tenecteplase is reconstituted with 3 ml sterile water for injection and adjusted to a concentration of 5.33 mg/ml. Calculate the total amount of drug according to the subject's actual body weight and measure the required drug volume. The maximum dose should not exceed 25mg. Tenecteplase should be given as a single, intravenous bolus (within 5-10 seconds).

Tenecteplase (0.25 mg/kg)

Standard medical treatment DRUG

Aspirin combined with clopidogrel, aspirin alone, or clopidogrel alone after randomization at the discretion of site researchers according to Chinese Guidelines for Diagnosis and Treatment of Acute Ischemic Stroke 2023.

Standard medical treatment

Eligibility Criteria

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

You may qualify if:

• )Age ≥ 18 years old;
• )Acute ischemic stroke symptom onset between 24 to 72 hours prior to enrollment; including wake-up stroke and unwitnessed stroke, onset time refers to 'last-seen normal time';
• )Pre-stroke modified Rankin scale (mRS) score ≤1;
• )Baseline National Institutes of Health Stroke Scale (NIHSS) 6-25 (both inclusive) or a score of 4 or 5 with a disabling deficit (e.g., hemianopia, aphasia, and loss of hand function);
• )Neuroimaging:
• Middle cerebral artery M1-M4 occlusion, ACA, PCA or basilar artery occlusion confirmed by CTA/MRA, being responsible for signs and symptoms of acute ischemic stroke;
• target mismatch profile on CTP or MRI+PWI (ischemic core volume \<70mL, mismatch ratio \>1.2, and mismatch volume \>10mL);
• )Written informed consent from patients or their legally authorized representatives.

You may not qualify if:

• )Present as a significant low-density lesion on CT
• )Allergy to tenecteplase
• )Rapidly improving symptoms at the discretion of the investigator
• )NIHSS consciousness score 1a \>2, or epileptic seizure, hemiplegia after seizures (Todd's palsy) or other neurological/mental illness such that the patient is not able to cooperate or unwilling to cooperate
• )Persistent blood pressure elevation (systolic ≥185 mmHg or diastolic ≥110 mmHg), despite blood pressure-lowering treatment
• )Blood glucose \<2.8 or \>22.2 mmol/L (point of care glucose testing is acceptable)
• )Active internal bleeding or at high risk of bleeding, e.g., major surgery, trauma or gastrointestinal or urinary tract hemorrhage within the previous 21 days, or arterial puncture at a non-compressible site within the previous 7 days
• )Any known impairment in coagulation due to comorbid disease or anticoagulant use. If on warfarin, then INR \>1.7 or prothrombin time \>15 seconds; use of any direct thrombin inhibitors or direct factor Xa inhibitors during the last 48 hours unless reversal of effect can be achieved with a reversal agent; any full dose heparin/heparinoid during the last 24 hours or with an aPTT greater than the upper limit of normal
• )Known defect of platelet function or platelet count below 100,000/mm3 (NB patients taking antiplatelet medication can be included)
• )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
• )Any terminal illness such that the patient would not be expected to survive more than 1 year
• )Unable to perform CTP or PWI
• )Hypodensity in \>1/3 MCA territory on non-contrast CT for MCA occlusion, and pc-ASPECTS \<6 for BAO
• )Acute or past intracerebral hemorrhage (ICH) identified by CT or MRI
• )Multiple arterial occlusion (bilateral MCA occlusion, MCA occlusion accompanied with basilar occlusion)

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing tiantan hospital

Beijing, 100070, China

RECRUITING

MeSH Terms

Conditions

Stroke; Ischemic Stroke

Interventions

Tenecteplase

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Tissue Plasminogen Activator; Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Plasminogen Activators; Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins

Central Study Contacts

Yongjun Wang

CONTACT

86-10-59978350; yongjunwang@ncrcnd.org.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• 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: April 24, 2025
• First Posted: May 1, 2025
• Study Start: May 30, 2025
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): May 30, 2027
• Last Updated: April 1, 2026

Record last verified: 2026-03

Locations

CN (1)