Intensive Medical Therapy for High-risk Intracranial or Extracranial Atherosclerosis
NCT ID: NCT03635749
Last Updated: 2023-07-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
6100 participants
INTERVENTIONAL
2018-09-17
2023-10-30
Brief Summary
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Detailed Description
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This trial is a randomized, double-blind, placebo-controlled, multicenter, 2×2 factorial designed clinical trial. 6100 patients in 250 centers in China will be enrolled with one of the following situations (1) Mild ischemic stroke (NIHSS 4\~5) within 24 hours of onset meets any of the following imaging conditions: a) Acute single cerebral infarction with criminal intracranial and extracranial atherosclerotic stenosis (stenosis rate ≥50%),b) Acute multiple cerebral infarction (considered to be caused by large artery atherosclerosis, including non-stenotic vulnerable plaque);Or (2) Moderate-to-high-risk TIA (ABCD2≥4) or mild ischemic stroke (NIHSS≤5) within 24 to 72 hours of onset meets any of the following imaging conditions: a) Medium and high risk TIA with criminal intracranial and extracranial atherosclerotic stenosis (stenosis rate ≥50%),b) Acute single cerebral infarction with criminal intracranial and extracranial atherosclerotic stenosis (stenosis rate ≥50%),c) Acute multiple cerebral infarction (considered to be caused by large artery atherosclerosis, including non-stenotic vulnerable plaque) . Patients will be randomly assigned into 4 groups according to the ratio of 1:1:1:1:
1. Intensive antiplatelet therapy + immediate high-intensity statin therapy (80mg atorvastatin)
2. Intensive antiplatelet therapy + delayed high-intensity statin therapy (40mg atorvastatin)
3. Standard antiplatelet therapy + immediate high-intensity statin therapy (80mg atorvastatin)
4. Standard antiplatelet therapy + delayed high-intensity statin therapy (40mg atorvastatin)
Face to face interviews will be made at baseline, 7, 14 (or hospital discharge), 90 ± 7 days and 12th month ± 14 days after randomization.
Survival curves will be estimated for the primary outcome using the Kaplan-Meier procedure and compared using a Cox regression model Wald test, stratified by the opposite arm of the factorial design. Safety outcomes will be calculated using the Kaplan-Meier curve to simulate the 3-month cumulative risk, and the Cox proportional hazards model to calculate the HR and 95% confidence interval.
Primary outcome is defined as stroke (including hemorrhagic and ischemic stroke). Secondary outcomes include composite vascular events (stroke, myocardial infarction, and cardiovascular death); ischemic stroke; transient ischemic attack; myocardial infarction; vascular death; all-cause death; poor functional outcome (mRS 2-6); and quality of life (EQ-5D scale). Safety outcomes, relating to antiplatelet therapy (i.e. bleeding, intracranial hemorrhage, and adverse events) and statin therapy (i.e. hepatotoxicity, muscle toxicity and adverse events) will be investigated.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
1. Intensive antiplatelet therapy + immediate high-intensity statin therapy (80mg atorvastatin)
2. Intensive antiplatelet therapy + delayed high-intensity statin therapy (40mg atorvastatin)
3. Standard antiplatelet therapy + immediate high-intensity statin therapy (80mg atorvastatin)
4. Standard antiplatelet therapy + delayed high-intensity statin therapy (40mg atorvastatin)
TREATMENT
QUADRUPLE
Two nearly identical tablet forms of Aspirin (100mg Aspirin and matching placebo) with almost the same size, color and smell will be used in this research.
Two nearly identical tablet forms of Atorvastatin (20mg Atorvastatin and matching placebo) with almost the same size, color and smell will be used in this research.
Centers are not able to apply unblinding with biological experiment in this study. Researchers shall never unblind the code unless special situations occur such as Serious Adverse Events (SAE), which is essential for treatment. Clinical outcomes of efficacy and safety are submitted to Adjudication Committee, who should be blinded to randomization, for final determination.
Study Groups
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DAPT + immediate high-intensity statin
This group will receive active clopidogrel and active aspirin (Dual antiplatelet therapy, DAPT); active atorvastatin calcium with high dosage in the early phase.
Intensive antiplatelet
Day 1：clopidogrel 300mg/day+ aspirin100-300mg/ day
Day2 - 21: clopidogrel 75mg/day+ aspirin 100mg/day
Day22 - 90: clopidogrel 75mg/day+aspirin placebo
Immediate high-intensity statin
Day 1 - 21：Atorvastatin calcium 80mg/day
Day 22 - 90：Atorvastatin calcium 40mg/day
DAPT + delayed high-intensity statin
This group will receive active clopidogrel and active aspirin (Dual antiplatelet therapy, DAPT); atorvastatin calcium placebo and active atorvastatin calcium with moderate dosage in the ealy phase.
Intensive antiplatelet
Day 1：clopidogrel 300mg/day+ aspirin100-300mg/ day
Day2 - 21: clopidogrel 75mg/day+ aspirin 100mg/day
Day22 - 90: clopidogrel 75mg/day+aspirin placebo
Delayed high-intensity statin
Day 1 - 3：Atorvastatin calcium placebo
Day 4 - 21：Atorvastatin calcium 40mg/day + Atorvastatin calcium placebo
Day 22 - 90：Atorvastatin calcium 40mg/day
Aspirin+immediate high-intensity statin
This group will receive active aspirin and clopidogrel placebo; active atorvastatin calcium with high dosage in the early phase.
Standard antiplatelet
Day 1: Aspirin 100-300mg/day + clopidogrel placebo
Day 2 - 90: Aspirin 100mg/day+ clopidogrel placebo
Immediate high-intensity statin
Day 1 - 21：Atorvastatin calcium 80mg/day
Day 22 - 90：Atorvastatin calcium 40mg/day
Aspirin+delayed high-intensity statin
This group will receive active aspirin and clopidogrel placebo; atorvastatin calcium placebo and active atorvastatin calcium with moderate dosage in the early phase.
Standard antiplatelet
Day 1: Aspirin 100-300mg/day + clopidogrel placebo
Day 2 - 90: Aspirin 100mg/day+ clopidogrel placebo
Delayed high-intensity statin
Day 1 - 3：Atorvastatin calcium placebo
Day 4 - 21：Atorvastatin calcium 40mg/day + Atorvastatin calcium placebo
Day 22 - 90：Atorvastatin calcium 40mg/day
Interventions
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Intensive antiplatelet
Day 1：clopidogrel 300mg/day+ aspirin100-300mg/ day
Day2 - 21: clopidogrel 75mg/day+ aspirin 100mg/day
Day22 - 90: clopidogrel 75mg/day+aspirin placebo
Standard antiplatelet
Day 1: Aspirin 100-300mg/day + clopidogrel placebo
Day 2 - 90: Aspirin 100mg/day+ clopidogrel placebo
Immediate high-intensity statin
Day 1 - 21：Atorvastatin calcium 80mg/day
Day 22 - 90：Atorvastatin calcium 40mg/day
Delayed high-intensity statin
Day 1 - 3：Atorvastatin calcium placebo
Day 4 - 21：Atorvastatin calcium 40mg/day + Atorvastatin calcium placebo
Day 22 - 90：Atorvastatin calcium 40mg/day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Any of the following three two situations:
(1) Mild ischemic stroke (NIHSS 4 to 5 points) within 24 hours of onset meets any of the following imaging conditions:
1. Acute single cerebral infarction with criminal intracranial and extracranial atherosclerotic stenosis (stenosis rate ≥50%)
2. Acute multiple cerebral infarction (considered to be caused by large artery atherosclerosis, including non-stenotic vulnerable plaque)
Or (2) Moderate-to-high-risk TIA (ABCD2≥4 points) or mild ischemic stroke (NIHSS≤5 points) within 24 to 72 hours of onset meets any of the following imaging conditions:
1. Medium and high risk TIA with criminal intracranial and extracranial atherosclerotic stenosis (stenosis rate ≥50%)
2. Acute single cerebral infarction with criminal intracranial and extracranial atherosclerotic stenosis (stenosis rate ≥50%)
3. Acute multiple cerebral infarction (considered to be caused by large artery atherosclerosis, including non-stenotic vulnerable plaque)
The rate of intracranial artery stenosis is assessed by MRA, CTA, or DSA according to WASID standards; the rate of extracranial artery stenosis is assessed by carotid ultrasound, CEMRA, CTA or DSA, according to NASCET standards; 3. Signed informed consent
Exclusion Criteria
2. Other ischemic cerebrovascular diseases with specific causes (eg. aortic dissection, vasculitis, vascular malformation, etc.)
3. Non-cerebral vascular disease (eg. intracranial tumors, multiple sclerosis)
4. Cerebral infarction of large area (infarct size greater than half the single lobe area)
5. CT indicating hemorrhagic transformation of cerebral infarction before randomization
6. Patients with pre-existing contraindications of using clopidogrel, aspirin or statin drugs:
Known history of allergy ; Severe heart failure and asthma ; Coagulant disorders and systemic bleeding ; Pre-existing drug - induced blood system disease or abnormal liver function ; Leukopenia (\< 2×109/l) or thrombocytopenia (\<100×109/l) ; active liver disease ; pregnancy or lactation period ; Severe heart failure：New York Heart Association (NYHA) Functional Classification III and IV
7. MRS \> 2 before the onset
8. Use of intravenous or arterial thrombolysis intravascular therapy or bridge therapy after onset
9. Use of defibrinating therapy like snake venom, defibrase, lumbrokinase, etc. or use of anticoagulant therapy like argatroban, or use of antiplatelet therapy except clopidogrel and aspirin, such as tirofiban, ticagrelor, ozagrel, and so on after onset.
10. Creatine Kinase(CK) more than 5 times of the upper limit of normal value after onset
11. Use of drugs affecting the metabolism of statins such as immune-suppressive drugs, antifungal agents, or fibrates drugs and so on, within 14 days before randomization.
12. Severe hepatic or renal insufficiency (Note: Severe hepatic insufficiency refers to the ALT value \> 2 times the upper limit of normal value or AST times \> 2 times the upper limit of normal value; Severe hepatic insufficiency is refers to creatinine values \> 1.5 times he upper limit of normal value or GFR \< 40 ml/min/1.73 m2)
13. Usage of dual antiplatelet therapy with aspirin plus clopidogrel within 14 days before randomization. (patients who received dual antiplatelet therapy (aspirin combined with clopidogrel) but did not use clopidogrel with loading dose after onset were excluded)
14. Use of Intensive statin therapy within 14 days before randomization（atorvastatin ≥40mg/d or rosuvastatin ≥ 20mg/d）.
15. Pre-existing intracranial hemorrhage（eg. ICH, SAH）
16. Gastrointestinal bleeding or major surgery occurred within 90 days before randomization.
17. Pre-existing extracranial angioplasty or vascular surgery
18. Anticipated requirement for long-term non-study antiplatelet drugs, or non-steroid anti-inflammatory drugs.
19. Experimental drugs need to stop due to angioplasty or vascular surgery, which was planned or likely to perform within 90 days after randomization
20. Patients with severe disease expected to live for less than 90 days
21. Pregnant or childbearing-age women who have no effective contraceptives or positive pregnancy test records
22. Patients who are undergoing experimental drugs or device tests
23. Unable to finish the follow-up of 90 days due to geographical factor or other reasons（eg. dementia, alcoholism, substance abuse, severe mental disease, etc.）
35 Years
80 Years
ALL
No
Sponsors
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Ministry of Science and Technology of the People´s Republic of China
OTHER_GOV
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, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Beijing Tiantan Hospital
Locations
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Tiantan Hospital
Beijing, Beijing Municipality, China
Anshan Central Hospital
Anshan, , China
General Hospital of Anshan Iron and Steel Company
Anshan, , China
Anyang People's Hospital
Anyang, , China
Baoding First Central Hospital
Baoding, , China
Beijing Hepingli Hospital
Beijing, , China
Benxi Central Hospital
Benxi, , China
First Hospital of Changsha
Changsha, , China
Second people's Hospital of Hunan Province
Changsha, , China
Xiangya Third Hospital of Central South University
Changsha, , China
Changzhi Medical College Affiliated Heping Hospital
Changzhi, , China
Changzhi People's Hospital
Changzhi, , China
Lu'an Group General Hospital
Changzhi, , China
Changzhou Second People's Hospital
Changzhou, , China
Changzhou Wujin Hospital of Traditional Chinese Medicine
Changzhou, , China
Chongqing Sanxia Central Hospital
Chongqing, , China
Southwest Hospital affiliated to the Army Military Medical University
Chongqing, , China
People's Hospital of Dali Bai Autonomous Prefecture
Dali, , China
Dalian Central Hospital
Dalian, , China
Dalian Friendship Hospital
Dalian, , China
Second people's Hospital of Dalian
Dalian, , China
Xinhua Hospital Affiliated to Dalian University
Dalian, , China
Datong Third People's Hospital
Datong, , China
Dazhou Central Hospital
Dazhou, , China
Dongguan Hong Wah hospital
Dongguan, , China
Donghua Hospital
Dongguan, , China
Dongyang People's Hospital
Dongyang, , China
People's Hospital of Dongying District
Dongying, , China
General Hospital of Fushun Mining Bureau
Fushun, , China
Fuxin Mining Group General Hospital
Fuxin, , China
Nanxi Mountain hospital in Guangxi District
Guilin, , China
Guiyang Second Hospital
Guiyang, , China
Handan Central Hospital
Handan, , China
Handan First Hospital
Handan, , China
General Hospital of the General Administration of agriculture and reclamation of Heilongjiang
Ha’erbin, , China
Second hospital of Hebei Medical University
Hebei, , China
Hengshui Sixth People's Hospital
Hengshui, , China
Nanhua Hospital Affiliated to Nanhua University
Hengyang, , China
The Inner Mongolia Autonomous Region people's Hospital
Hohhot, , China
First Affiliated Hospital of Jiamusi University
Jiamusi, , China
Jiamusi Central Hospital
Jiamusi, , China
Jilin Electric Power Hospital
Jilin, , China
Jinlin Central Hospital
Jilin, , China
Jinlin People's Hospital
Jilin, , China
Second hospital of Jilin University
Jilin, , China
Qianfo Hill Hospital of Shandong Province
Jinan, , China
Shandong Transportation Hospital
Jinan, , China
Affiliated Hospital of Jiujiang University
Jiujiang, , China
Jixi People's Hospital
Jixi, , China
Kaifeng Central Hospital
Kaifeng, , China
Liaocheng Brain Hospital
Liaocheng, , China
Liaocheng Second People's Hospital
Liaocheng, , China
Liaoyang Central Hospital
Liaoyang, , China
Linfen People's Hospital
Linfen, , China
Second Affiliated Hospital of Henan University of Science and Technology
Luoyang, , China
Luzhou Hospital of traditional Chinese Medicine
Luzhou, , China
Mishan People's Hospital
Mishan, , China
Mudanjiang Second People's Hospital
Mudanjiang, , China
Fourth Affiliated Hospital of Nanchang University
Nanchang, , China
Third Affiliated Hospital of Nanchang University
Nanchang, , China
Wuxi Affiliated Hospital of Nanjing University of Chinese Medicine
Nanjing, , China
Li Huili Hospital of Ningbo Medical Center
Ningbo, , China
Ningbo Second Hospital
Ningbo, , China
Ningde People's Hospital
Ningde, , China
Panjin Central Hospital
Panjin, , China
Pindingshan First People's Hospital
Pingdingshan, , China
Qiqihar First Hospital
Qiqihar, , China
Ruzhou First People's Hospital
Rizhao, , China
Sanmenxia Central Hospital
Sanmenxia, , China
Fifth People's Hospital of Shanghai City, affiliated to Fudan University
Shanghai, , China
Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, , China
Second hospital of Shanxi Medical University
Shanxi, , China
Shengzhou People's Hospital
Shaoxing, , China
Heilongjiang Agriculture and Reclamation Bei'an Administration Central Hospital
Shenyang, , China
Shenzhen Second People's Hospital
Shenzhen, , China
Shijiazhuang Pingan Hospital
Shijiazhuang, , China
First Hospital Affiliated to Suzhou University
Suzhou, , China
The Second Hospital Affiliated to Suzhou University
Suzhou, , China
Taizhou First People's Hospital
Taizhou, , China
Affiliated Hospital of North China Polytechnic University
Tangshan, , China
Tangshan Workers' Hospital
Tangshan, , China
Tianjin Fourth Central Hospital
Tianjin, , China
Tieling Central Hospital
Tieling, , China
Gaomi People's Hospital
Weifang, , China
People's Hospital of Wendeng District
Weihai, , China
People's Hospital of Wuhan University
Wuhan, , China
Wuhan Central Hospital
Wuhan, , China
Gansu Academy of Medical Sciences, Wuwei
Wuwei, , China
Wuxi People's Hospital
Wuxi, , China
Wuxi Second People's Hospital
Wuxi, , China
Xi'an 141 hospital
Xi'an, , China
Xian First Hospital
Xi'an, , China
Xinxiang Central Hospital
Xinxiang, , China
Xinyang Central Hospital
Xinyang, , China
Xuchang Central Hospital
Xuchang, , China
General Hospital of Xuzhou Mining Group
Xuzhou, , China
Xuzhou First People's Hospital
Xuzhou, , China
Yantai Yuhuangding Hospital Affiliated to Qiingdao University
Yantai, , China
Yibin First People's Hospital
Yibin, , China
Yichang First People's Hospital
Yichang, , China
Yingkou Central Hospital
Yingkou, , China
Yueyang Hospital of integrated traditional Chinese and Western Medicine Affiliated to Shanghai University of Traditional Chinese Medicine
Yueyang, , China
Dehong People's Hospital of Yunnan
Yunnan, , China
Zaozhuang Mining Group Zaozhuang hospital
Zaozhuang, , China
Zhangjiagang First People's Hospital
Zhangjiagang, , China
Zhangjiagang Traditional Chinese Medicine Hospital
Zhangjiagang, , China
Workers' Hospital of Hebei iron and Steel Group Xuanhua iron and Steel Co., Ltd.
Zhangjiakou, , China
Central Hospital of the Yellow River
Zhengzhou, , China
Zhengzhou First People's Hospital
Zhengzhou, , China
Affiliated Hospital of Jiangsu University
Zhenjiang, , China
Zhoukou Yongshan hospital
Zhoukou, , China
Zhumadian Central Hospital
Zhumadian, , China
Zigong First People's Hospital
Zigong, , China
Countries
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References
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Chen Y, Jiang L, Gao Y, Chen W, Yan H, Wang T, Yang Y, Yao D, Liu D, Pan Y, Wang Y. CYP2C19 Genotype and Efficacy of Clopidogrel Initiated Between 24 to 72 Hours for Ischemic Stroke. Stroke. 2025 Sep 18. doi: 10.1161/STROKEAHA.125.052167. Online ahead of print.
Xia Z, Gao Y, Chen W, Johnston SC, Amarenco P, Bath PM, Wang X, Yan H, Wang T, Yang Y, Zhang Y, Wang M, Jing J, Wang C, Wang Y, Wang Y, Pan Y. Dual Antiplatelet Therapy in Patients With Metabolic Syndrome After Mild Ischemic Stroke or Transient Ischemic Attack. J Am Heart Assoc. 2025 Aug 5;14(15):e041449. doi: 10.1161/JAHA.125.041449. Epub 2025 Jul 17.
Liu D, Yan H, Gao Y, Chen W, Johnston SC, Amarenco P, Bath PM, Wang X, Wang M, Wang T, Yang Y, Jing J, Wang C, Wang Y, Pan Y, Wang Y. Effect of history of hypertension on efficacy of clopidogrel-aspirin in ischemic stroke. Int J Stroke. 2025 Oct;20(8):1021-1030. doi: 10.1177/17474930251338618. Epub 2025 Apr 19.
Li H, Cheng M, Gao Y, Yan H, Wang Y, Johnston SC, Bath PM, Amarenco P, Yang Y, Chen W, Wang Y, Pan Y, Wang Y. Does the Burden of CSVD Modify the Efficacy of Dual Antiplatelet Therapy?: A Post Hoc Analysis of the INSPIRES Trial. Stroke. 2025 Jun;56(6):1376-1387. doi: 10.1161/STROKEAHA.124.049826. Epub 2025 Apr 7.
Zhou Q, Gao Y, Chen W, Johnston SC, Amarenco P, Bath PM, Wang X, Yan H, Wang T, Yang Y, Zhang Y, Yang Q, Wang M, Jing J, Wang C, Wang Y, Wang Y, Pan Y. Efficacy and Safety of Dual Antiplatelet Treatment up to 72 Hours in Acute Ischemic Stroke Stratified by Glycemic Status. Ann Neurol. 2025 Jul;98(1):174-182. doi: 10.1002/ana.27207. Epub 2025 Feb 11.
Zhang Y, Wang X, Gao Y, Chen W, Johnston SC, Amarenco P, Bath PM, Yan H, Wang T, Yang Y, Zhou Q, Wang M, Jing J, Wang C, Wang Y, Wang Y, Pan Y. Dual Antiplatelet Treatment up to 72 Hours After Ischemic Stroke Stratified by Risk Profile: A Post Hoc Analysis. Stroke. 2025 Jan;56(1):46-55. doi: 10.1161/STROKEAHA.124.049246. Epub 2024 Dec 20.
Guan L, Han S, Johnston SC, Bath PM, Amarenco P, Yang Y, Wang T, Jing J, Wang C, Gao Y, Chen W, Yan H, Wang X, Wang Y, Wang Y, Pan Y. Duration of Benefit and Risk of Dual Antiplatelet Therapy up to 72 Hours After Mild Ischemic Stroke and Transient Ischemic Attack. Neurology. 2024 Oct 8;103(7):e209845. doi: 10.1212/WNL.0000000000209845. Epub 2024 Sep 13.
Liu Y, Zhao J, Gao Y, Chen W, Johnston SC, Bath PM, Amarenco P, Yan H, Wang X, Yang Y, Wang T, Wang Y, Pan Y, Wang Y. Clopidogrel and Aspirin Initiated Between 24 to 72 Hours for Mild Ischemic Stroke: A Subgroup Analysis of the INSPIRES Randomized Clinical Trial. JAMA Netw Open. 2024 Sep 3;7(9):e2431938. doi: 10.1001/jamanetworkopen.2024.31938.
Gao Y, Jiang L, Pan Y, Chen W, Jing J, Wang C, Johnston SC, Amarenco P, Bath PM, Yang Y, Wang T, Han S, Meng X, Lin J, Zhao X, Liu L, Zhao J, Li Y, Zang Y, Zhang S, Yang H, Yang J, Wang Y, Li D, Wang Y, Liu D, Kang G, Wang Y, Wang Y; INSPIRES Investigators. Immediate- or Delayed-Intensive Statin in Acute Cerebral Ischemia: The INSPIRES Randomized Clinical Trial. JAMA Neurol. 2024 Jul 1;81(7):741-751. doi: 10.1001/jamaneurol.2024.1433.
Gao Y, Chen W, Pan Y, Jing J, Wang C, Johnston SC, Amarenco P, Bath PM, Jiang L, Yang Y, Wang T, Han S, Meng X, Lin J, Zhao X, Liu L, Zhao J, Li Y, Zang Y, Zhang S, Yang H, Yang J, Wang Y, Li D, Wang Y, Liu D, Kang G, Wang Y, Wang Y; INSPIRES Investigators. Dual Antiplatelet Treatment up to 72 Hours after Ischemic Stroke. N Engl J Med. 2023 Dec 28;389(26):2413-2424. doi: 10.1056/NEJMoa2309137.
Gao Y, Pan Y, Han S, Chen W, Jing J, Wang C, Yang Y, Wang T, Meng X, Zhao X, Liu L, Li H, Johnston SC, Amarenco P, Bath PM, Wang Y, Wang Y; INSPIRES Investigators. Rationale and design of a randomised double-blind 2x2 factorial trial comparing the effect of a 3-month intensive statin and antiplatelet therapy for patients with acute mild ischaemic stroke or high-risk TIA with intracranial or extracranial atherosclerosis (INSPIRES). Stroke Vasc Neurol. 2023 Jun;8(3):249-258. doi: 10.1136/svn-2022-002084. Epub 2023 Jan 27.
Other Identifiers
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2017YFC1307905
Identifier Type: -
Identifier Source: org_study_id
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