Tenecteplase for acute ischemic stroke with large vessel occlusion

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs051210055

Enrollment

220

Registered

2021-07-28

Start date

2021-12-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute ischemic stroke Ischemic stroke, thrombolysis, tenecteplase, alteplase, recanalization

Interventions

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).

tenecteplase, alteplase

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion 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

Design outcomes

Primary

Measure	Time frame
[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	—

Measure

Time frame

[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

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Secondary

Measure	Time frame
[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	—

Measure

Time frame

[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

—

Contacts

Public ContactYoshiko Hayashi

National Cerebral and Cardiovascular Center

hayashi.yoshiko@ncvc.go.jp+81-6-6170-1070

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026