Tenecteplase for acute ischemic stroke with large vessel occlusion

JRCT ID: jRCTs051210055

Registered date:28/07/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Acute ischemic stroke
• Date of first enrollment: 01/07/2021
• Target sample size: 220
• Study type: Interventional
• Intervention(s): In the randomized comparative phase, patients will be randomized to administer tenecteplase 0.25 mg/kg (n=110) or alteplase 0.6 mg/kg (n=110) groups (2 arm with 1:1 randomization).

Outcome(s)

Primary Outcome

[Safety confirmation phase]
Symptomatic intracranial hemorrhage within 24 - 36 hours

[Randomized comparative phase]
Primary efficacy outcome: Proportion of patients with substantial angiographic recanalization (mTICI 2b/2c/3) or absence of retrievable thrombus at initial angiogram
Primary safety outcome: Proportion of patients with symptomatic intracranial hemorrhage within 24 -36 hours, and mortality due to any cause at 90 days

Secondary Outcome

[Safety confirmation phase]
Symptomatic intracranial hemorrhage within 72 hours

[Randomized comparative phase]
Proportion of patients with more than 8 points reduction in NIHSS or reaching 0-1 at 72h after thrombolysis
modified Rankin Scale (mRS) at 90 days (shift analysis)
Proportion of patients with mRS 0-1 or no change from baseline at 90 days
Proportion of patients with mRS 0-2 or no change from baseline at 90 days

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Patients presenting with acute ischemic stroke
2. 20 years and over
3. Male or female
4. Eligible to commence intravenous thrombolysis within 4.5 hours of stroke onset
5. Arterial occlusion on CTA or MRA of ICA, M1, M2, or basilar artery
6. Eligible to commence mechanical thrombectomy (arterial puncture) within 6 hours of stroke onset
7. Written informed consent is obtained from patient or proxies

Exclude criteria

1. Pre-stroke mRS score 4 or more
2. More than 4.5 hours of stroke onset or last known well time
3. Contraindication to contrast agents
4. Any terminal illness that the patient would not be expected to survive more than 1 year
5. Breast-feeding or possibly pregnant
6. Patients who are participating or plan to participate in other clinical trials during this trial period
7. Considered ineligible for trial enrollment by the investigators

Related Information

• Primary Sponsor: Toyoda Kazunori
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development