Precision Reperfusion Therapy for Disabling Minor Stroke With Large Vessel Occlusion Beyond Time Window
TIME-MINOR
A Multicenter, Randomized, Open-Label, Blinded-Endpoint Trial of Tenecteplase Versus Dual Antiplatelet Therapy in Mild Disabling Ischemic Stroke With Large Vessel Occlusion Beyond 4.5 Hours (TIME-MINOR Trial)
1 other identifier
interventional
864
1 country
30
Brief Summary
To verify the efficacy and safety of intravenous tenecteplase (TNK) in patients with disabling minor stroke and large vessel occlusion (LVO) within a 4.5-24 hour time window.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 stroke
Started Mar 2026
30 active sites
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 Start
First participant enrolled
March 1, 2026
CompletedFirst Submitted
Initial submission to the registry
March 10, 2026
CompletedFirst Posted
Study publicly available on registry
March 17, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2028
March 17, 2026
March 1, 2026
2.3 years
March 10, 2026
March 12, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of patients with a modified Rankin Scale (mRS) score of 0-1 at 90 days.
Proportion of patients with a modified Rankin Scale (mRS) score of 0-1 at 90 days.
3 months after randomization
Secondary Outcomes (7)
Proportion of patients with mRS 0-2 at 90 days.
3 months after randomization
Distribution of mRS score at 90 days.
3 months after randomization
Rate of vessel recanalization.
3 months after randomization
Proportion of patients undergoing rescue mechanical thrombectomy.
cerebral infarction within 24 hours of onset
Proportion of patients with NIHSS score 0-1 or an improvement of ≥4 points from baseline at 24 hours, 7 days, or discharge (whichever occurs first).
24 hours, 7 days, or discharge after randomization
- +2 more secondary outcomes
Other Outcomes (8)
Increase in NIHSS score ≥4 points within 24 hours, excluding intracranial hemorrhage.
24 hours after randomization
Symptomatic intracranial hemorrhage (sICH) at 36 hours (ECASS III definition).
36 hours after randomization
sICH within 90 days (ECASS III definition).
3 months after randomization
- +5 more other outcomes
Study Arms (2)
Tenecteplase
EXPERIMENTALTenecteplase (0.25 mg/kg, intravenous bolus, maximum dose 25 mg) + Standard Medical Management
Standard Medical Management
ACTIVE COMPARATORImmediate Standard Medical Management
Interventions
Tenecteplase (0.25 mg/kg, intravenous bolus, maximum dose 25 mg) + Delayed dual antiplatelet therapy (initiated 24 hours after thrombolysis: Aspirin 100 mg orally once daily + Clopidogrel 75 mg orally once daily, or Aspirin 100 mg + Ticagrelor 90 mg orally twice daily, continued for 21 days)
Immediate dual antiplatelet therapy (Aspirin 100 mg orally once daily + Clopidogrel 75 mg orally once daily, or Aspirin 100 mg + Ticagrelor 90 mg orally twice daily, continued for 21 days)
Eligibility Criteria
You may qualify if:
- Male or female subjects (age ≥ 18 years).
- Diagnosis of acute ischemic stroke, with intracranial hemorrhage ruled out by CT or MRI.
- Time from stroke onset or last known well to randomization is 4.5 to 24 hours.
- NIHSS score 2-5 and meeting the definition of disabling deficit: complete hemianopia (NIHSS question 3 score ≥ 2); severe aphasia (NIHSS question 9 score ≥ 2); neglect (NIHSS question 11 score ≥ 1); any persistent limb weakness against gravity (NIHSS question 6 or 7 score ≥ 2); any functional deficit considered potentially disabling by the physician and patient, such as inability to perform basic activities of daily living (bathing, independent walking, toileting, personal hygiene, and eating) or return to work.
- LVO (internal carotid artery, middle cerebral artery M1/M2 segments) confirmed by CTA or MRA, including tandem lesions.
- Core infarct volume \< 70 ml, ischemic penumbra volume ≥ 15 ml, and mismatch ratio ≥ 1.8, as shown by CTP or MRI+MRP.
- Written informed consent.
You may not qualify if:
- Significant pre-stroke neurological deficit (pre-stroke mRS ≥ 2).
- History of stroke within the last 3 months.
- History of intracranial hemorrhage.
- Suspected subarachnoid hemorrhage.
- Intracranial tumor, vascular malformation, or aneurysm.
- Major surgery within the last 1 month.
- Systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 110 mmHg.
- Platelet count \< 10⁵/mm³.
- Heparin or oral anticoagulant therapy within 48 hours.
- Abnormal APTT.
- Thrombin or factor Xa inhibitors.
- Severe illness with life expectancy \< 3 months.
- Blood glucose \< 50 mg/dL (2.7 mmol/L).
- Participation in any other investigational drug or device study within the last 3 months.
- Pregnancy.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (30)
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001, China
Anshan Central Hospital
Anshan, Liaoning, 114001, China
Anshan Changda Hospital
Anshan, Liaoning, 114005, China
Benxi Central Hospital
Benxi, Liaoning, 117000, China
Chaoyang Central Hospital
Chaoyang, Liaoning, 122000, China
Dalian Municipal Central Hospital Affiliated of Dalian University of Technology
Dalian, Liaoning, 116033, China
Dandong Central Hospital
Dandong, Liaoning, 118000, China
Dandong First Hospital
Dandong, Liaoning, 118000, China
Fushun Central Hospital
Fushun, Liaoning, 113006, China
Liaojian Group Fukuang General Hospital
Fushun, Liaoning, 113008, China
Fuxin People's Hospital
Fuxin, Liaoning, 123000, China
Huludao Central Hospital
Huludao, Liaoning, 125000, China
The First Affiliated Hospital of Jinzhou Medical University
Jinzhou, Liaoning, 121001, China
Liaoyang Central Hospital
Liaoyang, Liaoning, 111000, China
Panjin Central Hospital
Panjin, Liaoning, 124010, China
The Second Affiliated Hospital of Shenyang Medical College
Shenyang, Liaoning, 110002, China
Liaoning Provincial People's Hospital
Shenyang, Liaoning, 110016, China
Shenyang Fifth People's Hospital
Shenyang, Liaoning, 110023, China
Central Hospital Affiliated to Shenyang Medical College
Shenyang, Liaoning, 110024, China
Shenyang Fourth People's Hospital
Shenyang, Liaoning, 110031, China
The Fourth Affiliated Hospital of China Medical University
Shenyang, Liaoning, 110032, China
Shenyang First People's Hospital
Shenyang, Liaoning, 110041, China
Shenyang Tenth People's Hospital
Shenyang, Liaoning, 110044, China
Sujiatun District Central Hospital
Shenyang, Liaoning, 110101, China
Tieling Central Hospital
Tieling, Liaoning, 112000, China
Tieling County Central Hospital
Tieling, Liaoning, 112600, China
Liaojian Group Tieling Coal General Hospital
Tieling, Liaoning, 112700, China
Wafangdian Central Hospital
Wafangdian, Liaoning, 116300, China
Wafangdian Third People's Hospital
Wafangdian, Liaoning, 116300, China
Yingkou Central Hospital
Yingkou, Liaoning, 115000, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- Multicenter, randomized, open-label, blinded-endpoint (PROBE design), 1:1 allocation, 90-day follow-up.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 10, 2026
First Posted
March 17, 2026
Study Start
March 1, 2026
Primary Completion (Estimated)
July 1, 2028
Study Completion (Estimated)
August 1, 2028
Last Updated
March 17, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share