AzTrials
AzTrials

Acute StrokePhase 3INSPIRESNCT03635749

Intensive Medical Therapy for High-risk Intracranial or Extracranial Atherosclerosis

A Phase 3 study testing Intensive antiplatelet, Standard antiplatelet and Immediate high-intensity statin in people with Acute Stroke and Transient Ischemic Attack, run by Beijing Tiantan Hospital at 113 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

Large-artery stenosis plays an important role in the occurrence of ischemic stroke. The primary purpose of this study is to evaluate the efficacy and safety of intensive antiplatelet therapy versus standard antiplatelet therapy and immediate high-intensity statin therapy (80mg atorvastatin) versus delayed… Read more about this study

Who is it for?
Ages 35 to 80 years
Conditions the study is for
Acute Stroke, Transient Ischemic Attack
What is being tested?
Intensive antiplatelet, Standard antiplatelet and Immediate high-intensity statin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
6,100 participants
Where
113 sitesChina
Study dates
17 Sep 2018to 30 Oct 2023
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age :35-80 years old , male or female;
  • Any of the following three two situations:
  • Mild ischemic stroke (NIHSS 4 to 5 points) within 24 hours of onset meets any of the following imaging conditions:
  • Acute single cerebral infarction with criminal intracranial and extracranial atherosclerotic stenosis (stenosis rate ≥50%)
  • 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:
Show all 10Show fewer
  • Medium and high risk TIA with criminal intracranial and extracranial atherosclerotic stenosis (stenosis rate ≥50%)
  • Acute single cerebral infarction with criminal intracranial and extracranial atherosclerotic stenosis (stenosis rate ≥50%)
  • 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

Who cannot join

  • Specific cardiogenic ischemic cerebrovascular diseases(eg. combined with atrial fibrillation, heart valve prosthesis, atrial myxoma, endocarditis, etc.)
  • Other ischemic cerebrovascular diseases with specific causes (eg. aortic dissection, vasculitis, vascular malformation, etc.)
  • Non-cerebral vascular disease (eg. intracranial tumors, multiple sclerosis)
  • Cerebral infarction of large area (infarct size greater than half the single lobe area)
  • CT indicating hemorrhagic transformation of cerebral infarction before randomization
  • Patients with pre-existing contraindications of using clopidogrel, aspirin or statin drugs:
Show all 24Show fewer
  • 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
  • MRS > 2 before the onset
  • Use of intravenous or arterial thrombolysis intravascular therapy or bridge therapy after onset
  • 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.
  • Creatine Kinase(CK) more than 5 times of the upper limit of normal value after onset
  • 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.
  • 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)
  • 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)
  • Use of Intensive statin therapy within 14 days before randomization（atorvastatin ≥40mg/d or rosuvastatin ≥ 20mg/d）.
  • Pre-existing intracranial hemorrhage（eg. ICH, SAH）
  • Gastrointestinal bleeding or major surgery occurred within 90 days before randomization.
  • Pre-existing extracranial angioplasty or vascular surgery
  • Anticipated requirement for long-term non-study antiplatelet drugs, or non-steroid anti-inflammatory drugs.
  • Experimental drugs need to stop due to angioplasty or vascular surgery, which was planned or likely to perform within 90 days after randomization
  • Patients with severe disease expected to live for less than 90 days
  • Pregnant or childbearing-age women who have no effective contraceptives or positive pregnancy test records
  • Patients who are undergoing experimental drugs or device tests
  • 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.）

Trial locations and contacts

113 sites in 1 country.

113 sites in 1 country

China113 sites

  • Anshan Central Hospital

    Anshan

  • General Hospital of Anshan Iron and Steel Company

    Anshan

  • Anyang People's Hospital

    Anyang

  • Baoding First Central Hospital

    Baoding

  • Tiantan Hospital

    Beijing, Beijing Municipality, 100050

  • Beijing Hepingli Hospital

    Beijing

  • Benxi Central Hospital

    Benxi

  • First Hospital of Changsha

    Changsha

  • Second people's Hospital of Hunan Province

    Changsha

  • Xiangya Third Hospital of Central South University

    Changsha

  • Changzhi Medical College Affiliated Heping Hospital

    Changzhi

  • Changzhi People's Hospital

    Changzhi

  • Lu'an Group General Hospital

    Changzhi

  • Changzhou Second People's Hospital

    Changzhou

  • Changzhou Wujin Hospital of Traditional Chinese Medicine

    Changzhou

  • Chongqing Sanxia Central Hospital

    Chongqing

  • Southwest Hospital affiliated to the Army Military Medical University

    Chongqing

  • People's Hospital of Dali Bai Autonomous Prefecture

    Dali

  • Dalian Central Hospital

    Dalian

  • Dalian Friendship Hospital

    Dalian

  • Second people's Hospital of Dalian

    Dalian

  • Xinhua Hospital Affiliated to Dalian University

    Dalian

  • Datong Third People's Hospital

    Datong

  • Dazhou Central Hospital

    Dazhou

  • Dongguan Hong Wah hospital

    Dongguan

  • Donghua Hospital

    Dongguan

  • Dongyang People's Hospital

    Dongyang

  • People's Hospital of Dongying District

    Dongying

  • General Hospital of Fushun Mining Bureau

    Fushun

  • Fuxin Mining Group General Hospital

    Fuxin

  • Nanxi Mountain hospital in Guangxi District

    Guilin

  • Guiyang Second Hospital

    Guiyang

  • General Hospital of the General Administration of agriculture and reclamation of Heilongjiang

    Ha’erbin

  • Handan Central Hospital

    Handan

  • Handan First Hospital

    Handan

  • Second hospital of Hebei Medical University

    Hebei

  • Hengshui Sixth People's Hospital

    Hengshui

  • Nanhua Hospital Affiliated to Nanhua University

    Hengyang

  • The Inner Mongolia Autonomous Region people's Hospital

    Hohhot

  • First Affiliated Hospital of Jiamusi University

    Jiamusi

  • Jiamusi Central Hospital

    Jiamusi

  • Jilin Electric Power Hospital

    Jilin City

  • Jinlin Central Hospital

    Jilin City

  • Jinlin People's Hospital

    Jilin City

  • Second hospital of Jilin University

    Jilin City

  • Qianfo Hill Hospital of Shandong Province

    Jinan

  • Shandong Transportation Hospital

    Jinan

  • Affiliated Hospital of Jiujiang University

    Jiujiang

  • Jixi People's Hospital

    Jixi

  • Kaifeng Central Hospital

    Kaifeng

  • Liaocheng Brain Hospital

    Liaocheng

  • Liaocheng Second People's Hospital

    Liaocheng

  • Liaoyang Central Hospital

    Liaoyang

  • Linfen People's Hospital

    Linfen

  • Second Affiliated Hospital of Henan University of Science and Technology

    Luoyang

  • Luzhou Hospital of traditional Chinese Medicine

    Luzhou

  • Mishan People's Hospital

    Mishan

  • Mudanjiang Second People's Hospital

    Mudanjiang

  • Fourth Affiliated Hospital of Nanchang University

    Nanchang

  • Third Affiliated Hospital of Nanchang University

    Nanchang

  • Wuxi Affiliated Hospital of Nanjing University of Chinese Medicine

    Nanjing

  • Li Huili Hospital of Ningbo Medical Center

    Ningbo

  • Ningbo Second Hospital

    Ningbo

  • Ningde People's Hospital

    Ningde

  • Panjin Central Hospital

    Panjin

  • Pindingshan First People's Hospital

    Pingdingshan

  • Qiqihar First Hospital

    Qiqihar

  • Ruzhou First People's Hospital

    Rizhao

  • Sanmenxia Central Hospital

    Sanmenxia

  • Fifth People's Hospital of Shanghai City, affiliated to Fudan University

    Shanghai

  • Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine

    Shanghai

  • Second hospital of Shanxi Medical University

    Shanxi

  • Shengzhou People's Hospital

    Shaoxing

  • Heilongjiang Agriculture and Reclamation Bei'an Administration Central Hospital

    Shenyang

  • Shenzhen Second People's Hospital

    Shenzhen

  • Shijiazhuang Pingan Hospital

    Shijiazhuang

  • First Hospital Affiliated to Suzhou University

    Suzhou

  • The Second Hospital Affiliated to Suzhou University

    Suzhou

  • Taizhou First People's Hospital

    Taizhou

  • Affiliated Hospital of North China Polytechnic University

    Tangshan

  • Tangshan Workers' Hospital

    Tangshan

  • Tianjin Fourth Central Hospital

    Tianjin

  • Tieling Central Hospital

    Tieling

  • Gaomi People's Hospital

    Weifang

  • People's Hospital of Wendeng District

    Weihai

  • People's Hospital of Wuhan University

    Wuhan

  • Wuhan Central Hospital

    Wuhan

  • Gansu Academy of Medical Sciences, Wuwei

    Wuwei

  • Wuxi People's Hospital

    Wuxi

  • Wuxi Second People's Hospital

    Wuxi

  • Xi'an 141 hospital

    Xi'an

  • Xian First Hospital

    Xi'an

  • Xinxiang Central Hospital

    Xinxiang

  • Xinyang Central Hospital

    Xinyang

  • Xuchang Central Hospital

    Xuchang

  • General Hospital of Xuzhou Mining Group

    Xuzhou

  • Xuzhou First People's Hospital

    Xuzhou

  • Yantai Yuhuangding Hospital Affiliated to Qiingdao University

    Yantai

  • Yibin First People's Hospital

    Yibin

  • Yichang First People's Hospital

    Yichang

  • Yingkou Central Hospital

    Yingkou

  • Yueyang Hospital of integrated traditional Chinese and Western Medicine Affiliated to Shanghai University of Traditional Chinese Medicine

    Yueyang

  • Dehong People's Hospital of Yunnan

    Yunnan

  • Zaozhuang Mining Group Zaozhuang hospital

    Zaozhuang

  • Zhangjiagang First People's Hospital

    Zhangjiagang

  • Zhangjiagang Traditional Chinese Medicine Hospital

    Zhangjiagang

  • Workers' Hospital of Hebei iron and Steel Group Xuanhua iron and Steel Co., Ltd.

    Zhangjiakou

  • Central Hospital of the Yellow River

    Zhengzhou

  • Zhengzhou First People's Hospital

    Zhengzhou

  • Affiliated Hospital of Jiangsu University

    Zhenjiang

  • Zhoukou Yongshan hospital

    Zhoukou

  • Zhumadian Central Hospital

    Zhumadian

  • Zigong First People's Hospital

    Zigong

Other trials in China

About this study

Official title: Intensive Statin and Antiplatelet Therapy for High-risk Intracranial or Extracranial Atherosclerosis (INSPIRES)

Large-artery stenosis plays an important role in the occurrence of ischemic stroke. The primary purpose of this study is to evaluate the efficacy and safety of intensive antiplatelet therapy versus standard antiplatelet therapy and immediate high-intensity statin therapy (80mg atorvastatin) versus delayed high-intensity statin therapy (40mg atorvastatin) and intensive antiplatelet combined with immediate high-intensity statin therapy (80mg atorvastatin) versus standard antiplatelet combined with delayed high-intensity statin therapy (40mg atorvastatin) in reducing the risk of stroke at 90 days in patients with acute and high-risk symptomatic extracranial or intracranial arterial stenosis.

Read the detailed description

Large-artery atherosclerotic stenosis is the main cause of ischemic stroke, especially in Asian population. However, targeted treatment evidence for large-artery atherosclerotic stenosis is limited according to the current guidelines. And also, randomized trial for statin therapy in patients with acute large arterial stenosis at early stage is still limited. The primary purpose of this study is to evaluate the efficacy and safety of intensive antiplatelet therapy versus standard antiplatelet therapy in reducing the risk of stroke at 90 days in patients with acute and high-risk symptomatic extracranial or intracranial arterial stenosis; the efficacy and safety of immediate high-intensity statin therapy (80mg atorvastatin) versus delayed high-intensity statin therapy (40mg atorvastatin) in reducing the risk of stroke at 90 days in patients with acute and high-risk symptomatic extracranial or intracranial arterial stenosis; and the efficacy and safety of intensive antiplatelet combined with immediate high-intensity statin therapy (80mg atorvastatin) versus standard antiplatelet combined with delayed high-intensity statin therapy (40mg atorvastatin) in reducing the risk of stroke at 90 days in patients with acute and high-risk symptomatic extracranial or intracranial arterial stenosis.

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.

Being tested
Intensive antiplatelet, Standard antiplatelet, Immediate high-intensity statin, Delayed high-intensity statin
Keywords
Acute Stroke, Transient Ischemic Attack, Antiplatelet Therapy, Randomized Controlled Trial, Double Blind Study, Multicenter Study, Symptomatic Extracranial or Intracranial Arterial Stenosis, Statin Therapy, Clinical Trial
Medical subject headings
Stroke, Ischemic Attack, Transient

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intensive antiplateletDrug

    Also called Dual 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 antiplateletDrug

    Also called Aspirin

    Day 1: Aspirin 100-300mg/day + clopidogrel placebo

    Day 2 - 90: Aspirin 100mg/day+ clopidogrel placebo

  • Immediate high-intensity statinDrug

    Also called Immediate Atorvastatin

    Day 1 - 21：Atorvastatin calcium 80mg/day

    Day 22 - 90：Atorvastatin calcium 40mg/day

  • Delayed high-intensity statinDrug

    Also called Delayed Atorvastatin

    Day 1 - 3：Atorvastatin calcium placebo

    Day 4 - 21：Atorvastatin calcium 40mg/day + Atorvastatin calcium placebo

    Day 22 - 90：Atorvastatin calcium 40mg/day

Study groups in NCT03635749
Study groupRoleWhat they receive
DAPT + immediate high-intensity statinActive comparatorThis group will receive active clopidogrel and active aspirin (Dual antiplatelet therapy, DAPT); active atorvastatin calcium with high dosage in the early phase.
Receives: Drug: Intensive antiplatelet; Drug: Immediate high-intensity statin
DAPT + delayed high-intensity statinOtherThis 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.
Receives: Drug: Intensive antiplatelet; Drug: Delayed high-intensity statin
Aspirin+immediate high-intensity statinOtherThis group will receive active aspirin and clopidogrel placebo; active atorvastatin calcium with high dosage in the early phase.
Receives: Drug: Standard antiplatelet; Drug: Immediate high-intensity statin
Aspirin+delayed high-intensity statinPlacebo comparatorThis group will receive active aspirin and clopidogrel placebo; atorvastatin calcium placebo and active atorvastatin calcium with moderate dosage in the early phase.
Receives: Drug: Standard antiplatelet; Drug: Delayed high-intensity statin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Stroke

    Symptoms and signs of acute neurological deficits caused by sudden focal or whole brain, spinal cord or retinal vascular damage, which are related to cerebral circulatory disorders, including hemorrhagic and ischemic stroke

    Measured: 90 days

Secondary outcomes (11)

  1. Composite vascular events

    stroke (including hemorrhagic and ischemic stroke), myocardial infarction, and cardiovascular death.

    Measured: 90 days

  2. Ischemic stroke

    An acute focal infarction of the brain or retina. Criteria:(1) acute onset of a new focal neurological deficit with clinical or imaging evidence of infarction lasting more than 24 hours and not attributable to a non-ischemic etiology (not associated with brain infection, trauma, tumor, seizure, severe metabolic disease, or degenerative neurological disease); or (2) acute onset of a new focal neurological deficit and not attributable to a non-ischemic etiology lasting less than 24 hours, but accompanied by neuroimaging evidence of new brain infarction; or, (3) rapid worsening of an existing focal neurological deficit (an increase in NIHSS of ≥4 on the basis of a primary ischemic stroke, excluding hemorrhagic transformation or symptomatic cranial disease after infarction) lasting more than 24 hours and not attributable to a non-ischemic etiology, and accompanied by new ischemic changes on brain MRI or CT.

    Measured: 90 days

  3. Transient ischemic attack

    A neurological deficit of sudden onset, resolving completely, attributed to focal brain or retinal ischemia without evidence of associated acute focal infarction of the brain. Criteria: rapid onset of a focal neurological deficit that is without evidence of acute focal infarction of the brain, and is not attributable to a non-ischemic etiology (brain infection, trauma, tumor, seizure, severe metabolic disease, or degenerative neurological disease)

    Measured: 90 days

  4. Myocardial infarction

    Acute myocardial infarction is diagnosed by the third edition of the international general diagnostic criteria (Glob Heart. 2012 Dec;7(4):275-95)

    Measured: 90 days

  5. Vascular death

    Vascular death includes stroke, sudden cardiac death, acute myocardial infarction, heart failure, pulmonary embolism, heart / cerebrovascular intervention or surgery (death unrelated to acute MI) and other cardiovascular causes of death [such as: Arrhythmia irrelevant with sudden cardiac death, aortic aneurysm rupture, or peripheral artery disease. Any death of unknown/unclear cause that occurs within 30 days after stroke, myocardial infarction, or cardio-cerebrovascular operation/surgery will be regarded as death due to stroke, myocardial infarction, or cardio-cerebrovascular operation/surgery, respectively.

    Measured: 90 days

  6. All-cause death

    All-cause death

    Measured: 90 days

  7. Poor functional outcome

    The modified Rankin Scale (mRS)= 2-6

    Measured: 90 days

  8. Quality of life (EQ-5D scale)

    EQ-5D scale index score ≤0.5

    Measured: 90 days

  9. Change of atherosclerotic plaque using high-resolution magnetic resonance imaging (HR-MRI)

    Change of atherosclerotic plaque using high-resolution magnetic resonance 。 Patients in HR-MRI subgroup only

    Measured: 90 days

  10. Early Neurological Deficits

    NIHSS score increase of no less than 2points

    Measured: 7 days

  11. Ordinal stroke or TIA

    The new stroke or TIA is classified on a six-level ordered category scale combined vascular events with mRS score at 90 days or at 1year, respectively: fatal stroke (stroke with subsequent death), severe stroke (stroke followed by mRS of 4-5), moderate stroke (stroke followed by mRS of 2-3), mild stroke (stroke followed by mRS of 0-1), TIA and no stroke/TIA.

    Measured: 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Aug 2018
  2. Study start17 Sep 2018
  3. Primary completion15 Jan 2023
  4. Study completion30 Oct 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Model description
The subjects are randomly assigned to the following four groups: 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)
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
6,100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03635749
Sponsor's protocol ID
2017YFC1307905
Acronym
INSPIRES
Status last verified
Jul 2023
First submitted
15 Aug 2018
Last updated
18 Jul 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Xia Z, Gao Y, Chen W, Johnston SC, Amarenco P, Bath PM, Wang X, Gao P, Yan H, Wang T, Yang Y, Zhang Y, Wang Y, Wang Y, Pan Y. Efficacy and safety of dual antiplatelet treatment up to 72 hours after mild ischemic stroke or transient ischemic attack in patients with established cardiovascular disease. Neurotherapeutics. 2026 Jul 10;23(4):e00963. doi: 10.1016/j.neurot.2026.e00963. Online ahead of print.

    PubMed 42430849

  • Li X, Gao Y, Yan H, Wang Y, Pan Y, Guan L, Wang Y. Efficacy and safety of clopidogrel and aspirin initiated within 72 hours after mild ischemic stroke or high-risk TIA by sex: a prespecified subgroup analysis of the INSPIRES trial. Expert Rev Cardiovasc Ther. 2026 Jul;24(7):663-673. doi: 10.1080/14779072.2026.2696285. Epub 2026 Jul 2.

    PubMed 42390058

  • Pan Y, Gao Y, Chen W, Johnston SC, Amarenco P, Bath PM, Jing J, Wang C, Jiang L, Yan H, Wang X, Yang Y, Wang T, Meng X, Lin J, Zhao X, Liu L, Wang Y, Wang Y. Dual Antiplatelet Therapy and Immediate Intensive Statin in Mild Ischemic Stroke: A Randomized Trial. Neurology. 2026 Jul 28;107(2):e218128. doi: 10.1212/WNL.0000000000218128. Epub 2026 Jun 25.

    PubMed 42348803

  • Cheng M, Li H, Gao Y, Yan H, Liu X, Yang Y, Chen W, Wang Y, Pan Y, Wang Y. White matter hyperintensities and 90-day outcomes in patients with mild ischaemic stroke or high-risk TIA. Stroke Vasc Neurol. 2026 Apr 16:svn-2025-004529. doi: 10.1136/svn-2025-004529. Online ahead of print.

    PubMed 41991239

  • Liu C, Li Y, Liu Z, Gao Y, Zhang Q, Wabnitz AM, Pan Y, Yan H, Chen W, Johnston SC, Wang D, Amarenco P, Bath PM, Wang Y, Wang Y, Guan L. The effect of dual antiplatelet therapy in different patterns of watershed infarction: Subgroup analysis of the INSPIRES trial. Cell Rep Med. 2026 Feb 17;7(2):102596. doi: 10.1016/j.xcrm.2026.102596. Epub 2026 Feb 5.

    PubMed 41650951

  • 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 Nov;56(11):3108-3117. doi: 10.1161/STROKEAHA.125.052167. Epub 2025 Sep 18.

    PubMed 40964718

  • 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.

    PubMed 40673545

  • 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.

    PubMed 40251953

  • 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.

    PubMed 40190261

  • 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.

    PubMed 39931900

  • 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.

    PubMed 39705390

  • 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.

    PubMed 39270151

  • 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.

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  • 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.

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Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Intensive antiplatelet, Standard antiplatelet and Immediate high-intensity statin in people with Acute Stroke and Transient Ischemic Attack, run by Beijing Tiantan Hospital at 113 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 18 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 113 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Stroke (time frame: 90 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03635749, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2023; AzTrials last refreshed its copy on 8 Nov 2026.

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