Clinical Trials List
Protocol Number1123-0060
Active
2025-12-01 - 2028-06-30
Phase III
Recruiting3
TENACITY – A phase III, prospective, randomized, open-label, blinded Probe-Based Evaluation (PROBE) trial evaluating the efficacy and safety of intravenous tenecteplase compared to standard of care in patients with acute ischemic stroke (including sleep-wake stroke) who have been in contact with the patient for more than 4.5 hours since their last known normality and have salvageable ischemic tissue imaging evidence.
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Trial Applicant
IQVIA RDS Taiwan Ltd.
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Sponsor
IQVIA Co., Ltd.
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Trial scale
Multi-Regional Multi-Center
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Update
2026/07/01
Investigators and Locations
Co-Principal Investigator
- Chon-Haw Tsai Division of Neurology
- Chung-Hsiang Liu Division of Neurology
- Wei-Shih Huang Division of Neurology
- Yuh-Cherng Guo Division of Neurology
- Yi-Ting Hsu Division of Neurology
- Hui-Chun Huang Division of Neurology
- Kuan-Fei Chen Division of Neurology
- Jui-Cheng Chen Division of Neurology
- Yi-Chien Yang Division of Neurology
- Hung-Yu Huang Division of Neurology
- Fu-Yu Lin Division of Neurology
- Ching-Hua Lu Lu Division of Neurology
- Sheng-Ta Tsai Division of Neurology
- Yu Ao Division of Neurology
- Wei-Chung Wang Division of Neurology
- 黃上芝 Division of Neurology
- 林欽揚 Division of Neurology
- 張芳慈 Division of Neurology
- 張育嘉 Division of Neurology
- 許乾盛 Division of Neurology
- 黃詩潔 Division of Neurology
Co-Principal Investigator
- Jiann-Shing Jeng Division of Neurology
- LI-KAI TSAI Division of Neurology
- SHIN-JOE YEH Division of Neurology
- 李崇維 Division of Radiology
- YEN-HENG LIN Division of Radiology
- CHIH-HAO CHEN Division of Neurology
Co-Principal Investigator
- 吳俊毅 Division of Emergency Medicine
- 陳耀亮 Division of Radiology
- 翁偉捷 Division of Neurology
- 蘇豐傑 Division of Neurology
- 魏怡嘉 Division of Neurology
- 林舜文 Division of Neurology
- 李景行 Division of Emergency Medicine
- 李光永 Division of Neurology
- 趙中豪 Division of Neurology
- 林語立 Division of Neurology
- 陳奕翔 Division of Neurology
Co-Principal Investigator
- 楊宗翰 Division of Radiology
- 許立奇 Division of Neurology
- 李怡慧 Division of Neurology
- Nai-Fang Chi Division of Neurology
- 林浚仁 Division of Neurology
- Hung-Yu Liu Division of Neurology
Co-Principal Investigator
- 陳嘉泓 Division of Neurology
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
張庭瑜
Co-Principal Investigator
- Hsiu-Chuan Wu Division of Neurology
- 張健宏 Division of Neurology
- Chi-Hung Liu Division of Neurology
- 吳逸民 Division of Neurology
- 鄭之光 Division of Neurology
- 柴雯燕 Division of Neurology
- 詹逸凌 Division of Neurology
- 張㝢智 Division of Neurology
- 江建霖 Division of Neurology
- 李亞倫 Division of Neurology
- 陳敏碩 Division of Neurology
- 楊茗臻 Division of Neurology
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Acute ischemic stroke (including sleep-wake stroke)
Objectives
The primary objective of this trial was to test the hypothesis that intravenous tenecteplase (0.25 mg/kg, up to a maximum of 25 mg) achieves superior functional outcomes (modified Rankin Scale [mRS] score of 0–1 on day 90) compared to standard care (excluding thrombolytic agents) in AIS participants who experienced stroke >4.5 hours prior to randomization (including both known and unknown onset times, with sleep-wake stroke falling into the latter category) and whose angiography showed significant salvageable ischemic tissue in the brain. The secondary objective was to assess the safety and efficacy of tenecteplase in patients in this context regarding key functional outcomes.
Test Drug
Tenecteplase
Active Ingredient
TENECTEPLASE
Dosage Form
Injectable
Dosage
25 mg/vial
Endpoints
The modified Rankin Scale [mRS] on day 90 was 0-1.
Inclution Criteria
Key inclusion criteria:
1. Males or females aged ≥18 years. If the legal age of consent in their country is greater than 18, they must meet that country's legal age of consent.
2. Before being admitted to this trial, participants must have signed and dated a written consent form in accordance with the International Council for Concordance on Good Clinical Practice (ICH-GCP) and local laws.
3. Acute ischemic stroke (including sleep-wake stroke) affecting the supratentorial circulation, with a time >4.5 hours prior to the scheduled randomization time.
4. Pre-stroke mRS ≤1.
5. Eligibility for contrast imaging as assessed by MRI or CT scan.
For further details, please refer to the participant consent form.
1. Males or females aged ≥18 years. If the legal age of consent in their country is greater than 18, they must meet that country's legal age of consent.
2. Before being admitted to this trial, participants must have signed and dated a written consent form in accordance with the International Council for Concordance on Good Clinical Practice (ICH-GCP) and local laws.
3. Acute ischemic stroke (including sleep-wake stroke) affecting the supratentorial circulation, with a time >4.5 hours prior to the scheduled randomization time.
4. Pre-stroke mRS ≤1.
5. Eligibility for contrast imaging as assessed by MRI or CT scan.
For further details, please refer to the participant consent form.
Exclusion Criteria
Key exclusion criteria:
1. Intention to undergo mechanical thrombectomy (MT) at the same trial center (hospital) where randomization is conducted.
2. Internal carotid artery (ICA) occlusion
3. High-risk patients (with a higher risk of thrombolysis-related bleeding)
4. Any intracranial hemorrhage detected on non-contrast-enhanced computed tomography (NCCT) or magnetic resonance imaging (MRI) scans
5. Contraindications to contrast-enhanced NCCT or MRI scans of the brain
6. Clinical assessment of severe stroke (NIHSS > 25 points)
7. Non-disabling minor stroke symptoms (NIHSS ≤ 5 points), or symptoms that improve rapidly as judged by the trial administrator
8. Angiographic or clinical findings not consistent with acute ischemic stroke, or showing that the stroke occurred more than 72 hours ago
9. The patient is expected to receive intravenous thrombolysis therapy according to standard care
10. Other known or confirmed central nervous system-related injuries (i.e., tumors, aneurysms and/or arterial/venous malformations, intracranial or spinal surgery)
11. Contraindications to Tenecteplase
For further details, please refer to the subject consent form.
1. Intention to undergo mechanical thrombectomy (MT) at the same trial center (hospital) where randomization is conducted.
2. Internal carotid artery (ICA) occlusion
3. High-risk patients (with a higher risk of thrombolysis-related bleeding)
4. Any intracranial hemorrhage detected on non-contrast-enhanced computed tomography (NCCT) or magnetic resonance imaging (MRI) scans
5. Contraindications to contrast-enhanced NCCT or MRI scans of the brain
6. Clinical assessment of severe stroke (NIHSS > 25 points)
7. Non-disabling minor stroke symptoms (NIHSS ≤ 5 points), or symptoms that improve rapidly as judged by the trial administrator
8. Angiographic or clinical findings not consistent with acute ischemic stroke, or showing that the stroke occurred more than 72 hours ago
9. The patient is expected to receive intravenous thrombolysis therapy according to standard care
10. Other known or confirmed central nervous system-related injuries (i.e., tumors, aneurysms and/or arterial/venous malformations, intracranial or spinal surgery)
11. Contraindications to Tenecteplase
For further details, please refer to the subject consent form.
The Estimated Number of Participants
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Taiwan
83 participants
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Global
1325 participants
