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Tenecteplase versus alteplase For LArge Vessel Occlusion Recanalization (T-FLAVOR)

Tenecteplase for acute ischemic stroke with large vessel occlusion (T-FLAVOR)

Toyoda Kazunori

National Cerebral and Cardiovascular Center

6-1, Kishibe-shimmachi, Suita Osaka

toyoda@ncvc.go.jp

Hayashi Yoshiko

National Cerebral and Cardiovascular Center

6-1, Kishibe-shimmachi, Suita Osaka

+81-6-6170-1070

hayashi.yoshiko@ncvc.go.jp

Not Recruiting

July. 01, 2021

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

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

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

Both

Acute ischemic stroke

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).

Ischemic stroke, thrombolysis, tenecteplase, alteplase, recanalization

tenecteplase, alteplase

[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

[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

+81-75-366-7618

April. 12, 2021

No

none