Study on Tirofiban With Aspirin in the Treatment of Acute Penetrating Artery Territory Infarction
NCT ID: NCT05310968
Last Updated: 2026-01-13
Study Results
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Basic Information
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COMPLETED
PHASE4
970 participants
INTERVENTIONAL
2022-11-12
2025-09-01
Brief Summary
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Detailed Description
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Currently, there are no evidence-supported, guideline-based on how to prevent the END of BAD. Combining the pathology of atherosclerosis, we hypothesize that short-term use of tirofiban with aspirin for intensive antiplatelet therapy may confer benefits.
The primary purpose of this study is to assess the efficacy and safety of tirofiban combined with aspirin versus placebo combined with aspirin in reducing END and stroke at 90 days in patients with BAD.
This is a prospective, randomized, multicenter, double-blind clinical trial. In China, 970 patients with the following criteria will be enrolled: single acute infarction of penetrating artery territory (maximum diameter \<30 mm on DWI of MRI) within 48 hours, which involves two or more transverse layers, or whose maximum diameter ≥15 mm, , or connected to the ventral surface of the median pons without crossing the midline on DWI image, no severe stenosis (defined as \<70%) of parent artery.
Patients will be randomly assigned into 2 groups:
1. Tirofiban + Aspirin (Day 1-90)
2. Placebo + Aspirin (Day 1-90) Interviews will be made on baseline, 24 hours after randomization, day 7 after randomization, discharge day, and day 90 after randomization.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Tirofiban group
This group will receive tirofiban and aspirin. Day 1: Tirofiban injected intravenously for 24 hours and aspirin of 100-300 mg. Tirofiban will be injected at 0.4 ug/kg/ min for the first 30 minutes and 0.1 ug/kg/min for the next 24 hours.
Day 2-90: Aspirin 100mg per day.
Tirofiban hydrochloride sodium chloride injection
Day 1: Tirofiban will be given by bolus injection at 0.4ug/kg/min for the first 30 minutes, followed by a continuous infusion at 0.1ug/kg/min for the next 24 hours.
Aspirin
Day 1: Aspirin 100-300mg per day Day 2-90: Aspirin 100mg per day
Tirofiban placebo group
This group will receive tirofiban placebo and aspirin. Day 1: Tirofiban placebo injected intravenously for 24 hours and aspirin of 100-300 mg. The placebo will be injected at the same rate with Tirofiban group.
Day 2-90: Aspirin 100mg per day.
Tirofiban hydrochloride sodium chloride injection placebo
Day 1: Tirofiban placebo will be injected at the same rate with experimental group.
Aspirin
Day 1: Aspirin 100-300mg per day Day 2-90: Aspirin 100mg per day
Interventions
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Tirofiban hydrochloride sodium chloride injection
Day 1: Tirofiban will be given by bolus injection at 0.4ug/kg/min for the first 30 minutes, followed by a continuous infusion at 0.1ug/kg/min for the next 24 hours.
Tirofiban hydrochloride sodium chloride injection placebo
Day 1: Tirofiban placebo will be injected at the same rate with experimental group.
Aspirin
Day 1: Aspirin 100-300mg per day Day 2-90: Aspirin 100mg per day
Eligibility Criteria
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Inclusion Criteria
2. Male or female;
3. Within 48 hours of onset;
4. Clinical symptoms and signs suggest acute single infarction of penetrating artery territory (no cortical involvement, no multifocal involvement, NIHSS ≤10 and consciousness-1a ≤1);
5. DWI suggests single infarction (diameter \< 30mm) of penetrating artery territory which involves at least 2 axial layers, or its maximum diameter ≥15mm, or it is connected to the ventral surface of the pons, closing to but not crossing the midline, and located in one side;
6. No severe stenosis (defined as \<70%) of parent artery;
7. The patient or his / her legal representative is able and willing to sign the informed consent.
Exclusion Criteria
2. History of intracranial tumors, cerebral arteriovenous malformation, or aneurysm;
3. Emergency endovascular intervention or intravenous thrombolysis before randomization;
4. Dual antiplatelet therapy currently or within 14 days of randomization (excluding use of aspirin and clopidogrel after onset without loading dose of clopidogrel);
5. Use of other antiplatelet drugs (ticagrelor, cilostazol, etc.), anticoagulant drugs, snake venom, defibrase, lumbrukinase or other defibrase treatments after onset;
6. Expected long-term use of non-investigational antiplatelet drugs or non-steroidal anti-inflammatory drugs;
7. With severe stenosis (\> 70%) of parent artery giving off responsible penetrating artery;
8. Definite indications for anticoagulation (suspicion of cardioembolism, e.g. atrial fibrillation, known heart valve prosthesis, atrial myxoma, endocarditis, etc.) or indications for dual antiplatelet therapy (e.g. recent coronary or cerebral artery stent implantation);
9. Severe hepatic or renal insufficiency before randomization (severe hepatic insufficiency refers to ALT or AST \> 3 times the upper limit of normal; severe renal insufficiency refers to creatinine clearance rate (CCr) \< 30ml/min);
10. Hemorrhagic tendency (including but not limited to)：PLT\<100×10\^9/L; heparin treatment within 48h; APTT ≥ 35s; current use of warfarin, INR \> 1.7; current use of novel oral anticoagulants; current use of direct thrombin or factor Xa inhibitor;
11. Resistant hypertension which could not be controlled by medicine (SBP \> 180mmHg or DBP \> 110mmHg);
12. History of obvious head trauma within three months of randomization;
13. History of intracranial or intramedullary surgery within three months of randomization;
14. History of major surgery or severe physical trauma within one month of randomization;
15. Severe neurological defects (mRS ≥ 2) before the onset;
16. Acute pericarditis;
17. Hemorrhagic retinopathy;
18. Childbearing-age women who do not take effective methods of contraception without negative records of pregnancy tests;
19. Known to be allergic to tirofiban;
20. Other surgical or interventional therapy planned within 3 months requiring experimental drugs discontinuation;
21. Life expectancy \< 6 months due to any terminal illness;
22. Patients who are undergoing experimental drugs or instruments;
23. Other conditions which suggest participants are unsuitable for this study, e.g. mental diseases, cognitive or mood disturbance,and could not comply with research procedures or with MRI contraindications.
18 Years
80 Years
ALL
No
Sponsors
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GrandPharma (China) Co., Ltd.
INDUSTRY
Beijing Tiantan Hospital
OTHER
Responsible Party
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yilong Wang
Vice President of Beijing Tiantan Hospital
Principal Investigators
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Yilong Wang, PhD，MD
Role: PRINCIPAL_INVESTIGATOR
Beijing Tiantan Hospital, Capital Medical University, Beijing, China
Locations
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The First Hospital of Fangshan District Beijing
Beijing, Beijing Municipality, China
School of Medicine, Xiamen University
Zhangzhou, Fujian, China
Guizhou Provincial People's Hospital
Guiyang, Guizhou, China
Hejian People's Hospital
Hejian, Hebei, China
Tangshan Gongren Hospital
Tangshan, Hebei, China
The People's Hospital of Qinghe County
Xingtai, Hebei, China
Mengzhou People's Hospital
Henan, Henan, China
Xiuwu People's Hospital
Jiaozuo, Henan, China
Jiyuan Hospital of Traditional Chinese Medicine
Jiyuan, Henan, China
The Second Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, China
Tanghe County People's Hospital
Nanyang, Henan, China
The First People's Hospital of Nanyang
Nanyang, Henan, China
Suixian Hospital of Traditional Chinese Medicine
Shangqiu, Henan, China
The People's Hospital of Biyang County
Zhumadian, Henan, China
Shaodong People's Hospital
Shaoyang, Hunan, China
Baotou Central Hospital
Baotou, Inner Mongolia, China
The First Affiliate Hospital of Baotou Medical College
Baotou, Inner Mongolia, China
Affiliated Nantong Hospital of Shanghai University (The Sixth People's Hospital of Nantong)
Nantong, Jiangsu, China
The People's Hospital of Suxitong Science & Technology Inductrial Park
Nantong, Jiangsu, China
The Affiliated Shuyang Hospital of Xuzhou Medical University
Suqian, Jiangsu, China
China-Japan Union Hospital of Jilin University
Changchun, Jilin, China
Benxi Central Hospital
Benxi, Liaoning, China
The First People's Hospital of Xianyang
Xianyang, Shaanxi, China
Ningjin People's Hospital
Dezhou, Shandong, China
Shandong Provincial Hospital Affiliated to Shandong First Medical University
Jinan, Shandong, China
Guanxian People's Hospital
Liaocheng, Shandong, China
Liaocheng Central Hospital
Liaocheng, Shandong, China
The People's Hospital of Gaotang County
Liaocheng, Shandong, China
The Second People's Hospital of Liaocheng
Liaocheng, Shandong, China
The Third People's Hospital of Liaocheng
Liaocheng, Shandong, China
The People's Hospital of Linqing
Linqing, Shandong, China
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Weihai Wendeng District People's Hospital
Weihai, Shandong, China
Zibo Municipal Hospital
Zibo, Shandong, China
Changzhi People's Hospital
Changzhi, Shanxi, China
Jincheng People's Hospital
Jincheng, Shanxi, China
Wanrong County People's Hospital
Yuncheng, Shanxi, China
Countries
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References
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Lu H, Howatt DA, Balakrishnan A, Graham MJ, Mullick AE, Daugherty A. Hypercholesterolemia Induced by a PCSK9 Gain-of-Function Mutation Augments Angiotensin II-Induced Abdominal Aortic Aneurysms in C57BL/6 Mice-Brief Report. Arterioscler Thromb Vasc Biol. 2016 Sep;36(9):1753-7. doi: 10.1161/ATVBAHA.116.307613. Epub 2016 Jul 28.
Seitz RJ, Meisel S, Moll M, Wittsack HJ, Junghans U, Siebler M. The effect of combined thrombolysis with rtPA and tirofiban on ischemic brain lesions. Neurology. 2004 Jun 8;62(11):2110-2. doi: 10.1212/01.wnl.0000129480.17345.4a.
Berberich A, Schneider C, Reiff T, Gumbinger C, Ringleb PA. Dual Antiplatelet Therapy Improves Functional Outcome in Patients With Progressive Lacunar Strokes. Stroke. 2019 Apr;50(4):1007-1009. doi: 10.1161/STROKEAHA.118.023789.
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Jeong HG, Kim BJ, Yang MH, Han MK, Bae HJ. Neuroimaging markers for early neurologic deterioration in single small subcortical infarction. Stroke. 2015 Mar;46(3):687-91. doi: 10.1161/STROKEAHA.114.007466. Epub 2015 Feb 12.
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Del Bene A, Palumbo V, Lamassa M, Saia V, Piccardi B, Inzitari D. Progressive lacunar stroke: review of mechanisms, prognostic features, and putative treatments. Int J Stroke. 2012 Jun;7(4):321-9. doi: 10.1111/j.1747-4949.2012.00789.x. Epub 2012 Mar 30.
Sudlow CL, Warlow CP. Comparable studies of the incidence of stroke and its pathological types: results from an international collaboration. International Stroke Incidence Collaboration. Stroke. 1997 Mar;28(3):491-9. doi: 10.1161/01.str.28.3.491.
Caplan LR. Lacunar infarction and small vessel disease: pathology and pathophysiology. J Stroke. 2015 Jan;17(1):2-6. doi: 10.5853/jos.2015.17.1.2. Epub 2015 Jan 30.
Bang OY. Intracranial atherosclerosis: current understanding and perspectives. J Stroke. 2014 Jan;16(1):27-35. doi: 10.5853/jos.2014.16.1.27. Epub 2014 Jan 31.
Kim BJ, Kim JS. Ischemic stroke subtype classification: an asian viewpoint. J Stroke. 2014 Jan;16(1):8-17. doi: 10.5853/jos.2014.16.1.8. Epub 2014 Jan 31.
Kim JS, Yoon Y. Single subcortical infarction associated with parental arterial disease: important yet neglected sub-type of atherothrombotic stroke. Int J Stroke. 2013 Apr;8(3):197-203. doi: 10.1111/j.1747-4949.2012.00816.x. Epub 2012 May 9.
Fisher CM. Capsular infarcts: the underlying vascular lesions. Arch Neurol. 1979 Feb;36(2):65-73. doi: 10.1001/archneur.1979.00500380035003.
Caplan LR. Intracranial branch atheromatous disease: a neglected, understudied, and underused concept. Neurology. 1989 Sep;39(9):1246-50. doi: 10.1212/wnl.39.9.1246. No abstract available.
Liao X, Feng S, Wang Y, Pan Y, Chen W, Qu H, Zhao X, Liu L, Wang Y, Wang Y. Tirofiban combined with Aspirin in the Treatment of Acute Penetrating Artery Territory Infarction (STRATEGY): protocol for a multicentre, randomised controlled trial. Stroke Vasc Neurol. 2024 Feb 27;9(1):75-81. doi: 10.1136/svn-2022-002284.
Other Identifiers
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KY2021-089-08
Identifier Type: -
Identifier Source: org_study_id
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