Ticagrelor With Aspirin Dual Antiplatelet Therapy Combined With Intravenous Thrombolysis for Ischemic Stroke
TAPIS
Efficacy and Safety of Ticagrelor With Aspirin Dual Antiplatelet Therapy Combined With Intravenous Thrombolysis in Patients With Ischemic Stroke (TAPIS): a Multicenter, Randomized, Double-blind, Placebo-parallel Controlled Trial
2 other identifiers
interventional
1,382
1 country
60
Brief Summary
Early antiplatelet therapy is promising for further improvement of functional prognosis on the basis of intravenous thrombolytic therapy. The primary purpose of this multicenter, randomized, double-blind, placebo-parallel controlled trial is to evaluate the efficacy and safety of the early dual antiplatelet therapy (within 6 hours of onset ) of ticagrelor with aspirin combined with intravenous thrombolysis in improving good functional outcome (mRS score 0-1) at 90 days inpatients with ischemic stroke.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2024
60 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
First Submitted
Initial submission to the registry
March 12, 2024
CompletedFirst Posted
Study publicly available on registry
March 18, 2024
CompletedStudy Start
First participant enrolled
April 3, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 5, 2026
CompletedJanuary 22, 2026
January 1, 2026
1.7 years
March 12, 2024
January 21, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Excellent functional outcome
Modified Rankin Scale (mRS) score of 0-1 points; The mRS score ranges from 0 to 6, with higher scores indicating worse functional outcome.
90 days
Secondary Outcomes (13)
mRS score of 0-2 points
90 days
Distribution of mRS score
90 days
Neurologic improvement
7 days
Quality of life (EQ-5D scale)
90 days
Activity of daily living (Barthel index ≥95 points)
90 days
- +8 more secondary outcomes
Study Arms (2)
Dual Antiplatelet Therapy
EXPERIMENTALThis group will receive early dual antiplatelet therapy (Ticagrelor with Aspirin) combined with intravenous thrombolysis within 6 hours of the onset.
Placebo
PLACEBO COMPARATORThis group will receive placebo treatment (with same form and dosage) combined with intravenous thrombolysis within 6 hours of the onset.
Interventions
Day 1(within 6.0 hours of onset, before or after intravenous thrombolysis) : Ticagrelor (180mg) + Aspirin (100mg), one dose; Days 2-7: Ticagrelor (90mg/time, twice/day) + open-label Aspirin (100mg/time, once/day) ; Days 8-90: open-label Aspirin (100mg/time, once/day).
Day 1(within 6.0 hours of onset, before or after intravenous thrombolysis) : Placebo of Ticagrelor (180mg) + Placebo of Aspirin (100mg), one dose; Days 2-7: Placebo of Ticagrelor (90mg/time, twice/day) + open-label Aspirin (100mg/time, once/day) ; Days 8-90: open-label Aspirin (100mg/time, once/day).
Eligibility Criteria
You may qualify if:
- \. 18-80 years old;
- \. Clinical diagnosis of acute ischemic stroke;
- \. Time from onset to treatment ≤6.0 hours;
- \. Having received or planning to receive intravenous thrombolytic therapy;
- \. NIHSS score of 4-10 points, and at least one of the 5th (upper limb exercise) or 6 th (lower limb exercise) scale is ≥1 point;
- \. Signed informed consent.
You may not qualify if:
- \. Planning to receive endovascular therapy;
- \. mRS scores ≥2 points before the onset;
- \. Receiving any antiplatelet therapy after the onset;
- \. Bleeding or other pathological brain disorders, such as vascular malformations, tumors, abscesses, or other common non-ischemic brain diseases (such as multiple sclerosis), identified by CT/MRI;
- \. Pre-existing clotting disorders, systemic bleeding, thrombocytopenia, or neutropenia;
- \. Pre-existing atrial fibrillation or anticoagulant therapy (warfarin, heparin, thrombin inhibitors or factor Xa inhibitors);
- \. Hepatic or renal insufficiency (hepatic insufficiency refers to the alanine transaminase (ALT) value \> 2 times the upper limit of normal value or aspartate aminotransferase (AST) times \> 2 times the upper limit of normal value; renal insufficiency refers to creatinine values \> 2 times the upper limit of normal value);
- \. Allergic to Ticagrelor or Aspirin or thier components and excipients;
- \. Women who are pregnant or breastfeeding, or those with negative pregnancy test records while refusing to use effective contraceptives;
- \. Having participated investigational drugs or device tests within 30 days;
- \. Being considered inappropriate to participate by researchers.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (60)
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
The First Hospital of Fangshan District
Beijing, Beijing Municipality, China
Heyuan City Hospital of Traditional Chinese Medicine
Heyuan, Guangdong, China
The Fifth Affiliated Hospital, Sun Yat-sen University
Zhuhai, Guangdong, China
Wuming Hospital of Guangxi Medical University
Nanning, Guangxi, China
Yulin First People's Hospital
Yulin, Guangxi, China
Affiliated Hospital of North China University of Science and Technology
Tangshan, Hebei, China
Linxi County People's Hospital
Xingtai, Hebei, China
Ningjin County Hospital of Hebei Province
Xingtai, Hebei, China
Qinghe People's Hospital
Xingtai, Hebei, China
Renze District People's Hospital
Xingtai, Hebei, China
Xingtai Ninth Hospital
Xingtai, Hebei, China
The First Affiliated Hospital of Hebei North University
Zhangjiakou, Hebei, China
Yangyuan County People's Hospital
Zhangjiakou, Hebei, China
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Puyang Anyang District Hospital
Anyang, Henan, China
Henan Wenxian People's Hospital
Jiaozuo, Henan, China
Jiaozuo People's Hospital
Jiaozuo, Henan, China
Jiyuan Hospital of Traditional Chinese Medicine
Jiyuan, Henan, China
Kaifeng Central Hospital
Kaifeng, Henan, China
Lankao County Hospital of Traditional Chinese Medicine
Kaifeng, Henan, China
Qi County Traditional Chinese Medicine Hospital
Kaifeng, Henan, China
Qixian People's Hospital
Kaifeng, Henan, China
The People's Hospital of Weishi
Kaifeng, Henan, China
Xiangfu District First People's Hospital
Kaifeng, Henan, China
Luoyang First People's Hospital
Luoyang, Henan, China
Luoyang Mengjin People's Hospital
Luoyang, Henan, China
Song County People's Hospital
Luoyang, Henan, China
Sanmenxia Hospital of the Yellow River, Affiliated to Henan University of Science and Technology
Sanmenxia, Henan, China
Henan Sui County Hospital of Traditional Chinese Medicine
Shangqiu, Henan, China
Suixian People's Hospital
Shangqiu, Henan, China
Weishi Central Hospital
Weishi Chengguanzhen, Henan, China
Weishi County Central Hospital
Weishi Chengguanzhen, Henan, China
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan, China
Huangpi District People's Hospital of Wuhan City
Wuhan, Hubei, China
Liuyang Jili Hospital
Changsha, Hunan, China
Chenzhou First People's Hospital
Chenzhou, Hunan, China
Chenzhou Fourth People's Hospital
Chenzhou, Hunan, China
Tuquan People's Hospital
Hinggan, Inner Mongolia, China
Zhalantun City Hospital of Chinese and Mongolian Medicine
Hulunbuir, Inner Mongolia, China
Anshan Changda Hospital
Anshan, Liaoning, China
Benxi Central Hospital
Benxi, Liaoning, China
Dalian Lvshun district people's hospital
Dalian, Liaoning, China
Dalian University Affiliated Xinhua Hospital
Dalian, Liaoning, China
The First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, China
Dandong Central Hospital
Dandong, Liaoning, China
The First People's Hospital of Shenyang
Shenyang, Liaoning, China
The Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Neimenggu, China
Lingbao First People's Hospital
Henan, Sanmenxia, China
Yantai Penglai Traditional Chinese Medicine Hospital
Dengzhou, Shandong, China
Linyi City People Hospital
Linyi, Shandong, China
Weihai Wendeng District People's Hospital
Weihai, Shandong, China
Zibo Municipal Hospital
Zibo, Shandong, China
Yuci District People's Hospital
Jinzhong, Shanxi, China
Linfen Central Hospital
Linfen, Shanxi, China
Linfen People's Hospital
Linfen, Shanxi, China
Weinan Central Hospital
Weinan, Shanxi, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Tianjin Xiqing Hospital
Tianjin, Tianjin Municipality, China
The First Afflicted Hospital of Shihezi University
Shihezi, Xinjiang, China
Related Publications (1)
Wang A, Xia X, Bath PM, Turc G, Li J, Zhang X, Wang Y. Rationale and design of Ticagrelor with Aspirin Dual Antiplatelet Therapy Combined with Intravenous Thrombolysis in Patients with Ischemic Stroke (TAPIS): a multicentre, randomised, double-blind, parallel group, placebo-controlled trial. Stroke Vasc Neurol. 2026 Jan 29:svn-2025-004721. doi: 10.1136/svn-2025-004721. Online ahead of print.
PMID: 41611343DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yilong Wang, MD, PhD
Beijing Tiantan Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Vice President of Beijing Tiantan Hospital
Study Record Dates
First Submitted
March 12, 2024
First Posted
March 18, 2024
Study Start
April 3, 2024
Primary Completion
December 31, 2025
Study Completion
January 5, 2026
Last Updated
January 22, 2026
Record last verified: 2026-01