NCT07375953

Brief Summary

Despite being the standard pharmacological reperfusion therapy for acute ischemic stroke, intravenous thrombolysis is limited by suboptimal recanalization rates. Tenecteplase (TNK), a newer thrombolytic agent, offers practical advantages over alteplase, including single bolus administration. However, a significant proportion of patients fail to achieve early clinical improvement after standard thrombolysis, likely due to persistent vessel occlusion. This study proposes to investigate a rescue strategy for patients who do not show significant neurological improvement within one hour after receiving standard intravenous tenecteplase within 3 hours of stroke onset. The primary objective is to evaluate the safety and feasibility of administering a second dose of tenecteplase in this scenario. The study will also explore the potential efficacy of this approach in improving recanalization and functional outcomes.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
19mo left

Started Mar 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress13%
Mar 2026Dec 2027

First Submitted

Initial submission to the registry

January 22, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 29, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

March 25, 2026

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2027

Last Updated

April 1, 2026

Status Verified

March 1, 2026

Enrollment Period

1.8 years

First QC Date

January 22, 2026

Last Update Submit

March 31, 2026

Conditions

Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

  • proportion of excellent functional outcome (modified Rankin Scale (mRS) 0-1)

    The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome

    90±7 days

Secondary Outcomes (11)

  • proportion of modified Rankin Scale (mRS) 0-2

    90±7 days

  • ordinal distribution of modified Rankin Scale (mRS)

    90±7 days

  • occurrence of early neurological improvement (ENI)

    24 (-6/+12) hours

  • change in National Institute of Health stroke scale (NIHSS) score

    24 (-6/+12) hours

  • change in National Institute of Health stroke scale (NIHSS) score

    10±2 days

  • +6 more secondary outcomes

Study Arms (2)

TNK group

EXPERIMENTAL

Tenecteplase is administered intravenously at a dose of 16 mg, with a maximum dose of 0.25 mg/kg.

Drug: Tenecteplase

Control group

NO INTERVENTION

No tenecteplase

Interventions

TenecteplaseDRUG

Tenecteplase is administered intravenously at a dose of 16 mg, with a maximum dose of 0.25 mg/kg.

TNK group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 year;
  • Acute ischemic stroke within 3 hours of onset, having received standard intravenous thrombolysis;
  • Measurable neurological deficit before the first intravenous thrombolysis, with NIHSS ≥ 4;
  • No significant clinical improvement (reduction in NIHSS ≤ 2) or neurological deterioration after initial improvement at 1 hour after the first thrombolysis, with intracranial hemorrhage ruled out by neuroimaging;
  • The second intravenous thrombolysis can be administered within 4.5 hours of onset;
  • First stroke onset or past stroke without obvious neurological deficit (mRS≤1);
  • Signed informed consent.

You may not qualify if:

  • Planed for endovascular treatment;
  • Significant cerebral white matter hyperintensities (Fazekas score 3)；
  • Any coagulation abnormality before the first thrombolysis, including INR \> 1.5；
  • Pregnancy；
  • Allergy to the investigational drug(s)；
  • Receipt of dual antiplatelet therapy within 24 hours prior to thrombolysis;
  • Comorbidity with other serious diseases;
  • Participating in other clinical trials within 3 months;
  • Patients not suitable for the study considered by researcher.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yu Cui

Shenyang, None Selected, 110840, China

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Tenecteplase

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Tissue Plasminogen ActivatorSerine EndopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesSerine ProteasesPlasminogen ActivatorsBlood Coagulation FactorsBlood ProteinsProteinsAmino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

January 22, 2026

First Posted

January 29, 2026

Study Start

March 25, 2026

Primary Completion (Estimated)

December 30, 2027

Study Completion (Estimated)

December 30, 2027

Last Updated

April 1, 2026

Record last verified: 2026-03

Locations

CN(1)