Clopidogrel in High-risk Patients With Acute Non-disabling Cerebrovascular Events

NCT00979589 | Completed Phase 3 DMC

• 1 other identifier: 2008ZX09312-008
• Study Type: interventional
• Target: 5,100
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the effects of a 3-month regimen of clopidogrel initiated with a loading dose (LD) of 300 mg followed by 75 mg/day during the first 21days versus a 3-month regimen of ASA 75 mg/day alone on reducing the 3-month risk of any stroke (both ischemic and hemorrhagic, primary outcome) when initiated within 24 hours of symptom onset in high-risk patients with TIA or minor stroke.

Conditions

Stroke; Transient Ischemic Attack

Keywords

stroke; transient ischemic attack; acute treatment; acute non-disabling cerebrovascular event; clopidogrel; clopidogrel combined with ASA; recurrence of stroke and other vascular events

Outcome Measures

Primary Outcomes (1)

• Percentage of patients with the 3-month new vascular events, defined as any event of the following: Any stroke (ischemic or hemorrhage)

  3 months

Secondary Outcomes (9)

• Percentage of patients with the 3-month new clinical vascular events (ischemic stroke/ hemorrhagic stroke/ TIA/ MI/ vascular death) as a cluster and evaluated individually.

  3 months

• Modified Rankin Scale score changes (continuous) and dichotomized at percentage with score 0-2 vs. 3-6 at 3 month follow-up

  3 months

• Further efficacy exploratory analysis:Impairment (changes in NIHSS scores at 3 month follow-up).

  3 months

• Further efficacy exploratory analysis:Quality of Life (EuroQol EQ-5D scale)

  3 months

• Efficacy endpoint will also be analyzed stratified by etiological subtypes, by time randomization (< 12 hours vs. ≥ 12 hours), by qualifying event (TIA vs. minor stroke), and by age

  3 months

Study Arms (2)

Combination Clopidogrel and asprin

ACTIVE COMPARATOR

Drug: Clopidogrel

Asprin and placebo

PLACEBO COMPARATOR

Drug: Placebo of clopidogrel and Asprin

Interventions

Clopidogrel DRUG

The first group will receive a 300mg loading dose (LD) of clopidogrel on the day of randomization, followed by 75 mg clopidogrel/day from Day 2 to 3 months. ASA will be given in a total dose ranging between 75 mg and 300 mg (open label) on the first day, followed by blinded 75 mg once /day from Day 2 to Day 21st. Between Day 21st and 3-month visits, ASA 75 mg will be replaced by a placebo of ASA 75 mg.

Also known as: Plavix

Combination Clopidogrel and asprin

Placebo of clopidogrel and Asprin DRUG

The second group will receive open label ASA in a total dose ranging between 75 mg and 300 mg on the first day, followed by blinded 75 mg once /day from Day 2 to 3 months. A placebo for clopidogrel will be given from the day of randomization until the 3-month visit.

Also known as: Acetylsalicylic acid

Asprin and placebo

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult subjects (male or female≥40 years)
• Acute non-disabling ischemic stroke (NIHSS≤3 at the time of randomization) that can be treated with study drug within 24 hours of symptoms onset. Symptom onset is defined by the "last see normal" principle
• TIA (Neurological deficit attributed to focal brain ischemia, with resolution of the deficit within 24 hours of symptom onset), that can be treated with study drug within 24 hours of symptoms onset and with moderate-to-high risk of stroke recurrence (ABCD2 score≥4 at the time of randomization).Symptom onset is defined by the "last see normal" principle
• Informed consent signed

You may not qualify if:

• Diagnosis of hemorrhage or other pathology, such as vascular malformation, tumor, abscess or other major non-ischemic brain disease (e.g., multiple sclerosis) on baseline head CT or MRI
• Isolated or pure sensory symptoms (e.g., numbness), isolated visual changes, or isolated dizziness/vertigo without evidence of acute infarction on baseline head CT or MRI
• Modified Rankin Scale Score\>2 at randomization (pre-morbid historical assessment)
• NIH Stroke Score≥4 at randomization
• Clear indication for anticoagulation(presumed cardiac source of embolus, e.g., atrial fibrillation, prosthetic cardiac valves known or suspected endocarditis)
• Contraindication to clopidogrel or ASA
• Known allergy
• Severe renal or hepatic insufficiency
• Severe cardiac failure, asthma
• Hemostatic disorder or systemic bleeding
• History of hemostatic disorder or systemic bleeding
• History of thrombocytopenia or neutropenia
• History of drug-induced hematologic or hepatic abnormalities
• Low white blood cell (\<2 x109/l) or platelet count (\<100 x109/l)
• Use of thrombolysis within 24 hours prior to randomization

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead
• University of California, San Francisco: collaborator

Study Sites (1)

Beijing Tian Tan Hospital, Capital Medical University

Beijing, 100050, China

Location

Related Publications (42)

• Wang Y, Johnston SC; CHANCE Investigators. Rationale and design of a randomized, double-blind trial comparing the effects of a 3-month clopidogrel-aspirin regimen versus aspirin alone for the treatment of high-risk patients with acute nondisabling cerebrovascular event. Am Heart J. 2010 Sep;160(3):380-386.e1. doi: 10.1016/j.ahj.2010.05.017.

  PMID: 20826243 BACKGROUND

• Wang Y, Zhao X, Lin J, Li H, Johnston SC, Lin Y, Pan Y, Liu L, Wang D, Wang C, Meng X, Xu J, Wang Y; CHANCE investigators. Association Between CYP2C19 Loss-of-Function Allele Status and Efficacy of Clopidogrel for Risk Reduction Among Patients With Minor Stroke or Transient Ischemic Attack. JAMA. 2016 Jul 5;316(1):70-8. doi: 10.1001/jama.2016.8662.

  PMID: 27348249 BACKGROUND

• Jing J, Meng X, Zhao X, Liu L, Wang A, Pan Y, Li H, Wang D, Johnston SC, Wang Y, Wang Y. Dual Antiplatelet Therapy in Transient Ischemic Attack and Minor Stroke With Different Infarction Patterns: Subgroup Analysis of the CHANCE Randomized Clinical Trial. JAMA Neurol. 2018 Jun 1;75(6):711-719. doi: 10.1001/jamaneurol.2018.0247.

  PMID: 29582084 BACKGROUND

• Pan Y, Elm JJ, Li H, Easton JD, Wang Y, Farrant M, Meng X, Kim AS, Zhao X, Meurer WJ, Liu L, Dietrich D, Wang Y, Johnston SC. Outcomes Associated With Clopidogrel-Aspirin Use in Minor Stroke or Transient Ischemic Attack: A Pooled Analysis of Clopidogrel in High-Risk Patients With Acute Non-Disabling Cerebrovascular Events (CHANCE) and Platelet-Oriented Inhibition in New TIA and Minor Ischemic Stroke (POINT) Trials. JAMA Neurol. 2019 Dec 1;76(12):1466-1473. doi: 10.1001/jamaneurol.2019.2531.

  PMID: 31424481 BACKGROUND

• Pan Y, Meng X, Jing J, Li H, Zhao X, Liu L, Wang D, Johnston SC, Wang Y, Wang Y; CHANCE Investigators. Association of multiple infarctions and ICAS with outcomes of minor stroke and TIA. Neurology. 2017 Mar 14;88(11):1081-1088. doi: 10.1212/WNL.0000000000003719. Epub 2017 Feb 15.

  PMID: 28202699 BACKGROUND

• Pan Y, Jing J, Chen W, Meng X, Li H, Zhao X, Liu L, Wang D, Johnston SC, Wang Y, Wang Y; CHANCE investigators. Risks and benefits of clopidogrel-aspirin in minor stroke or TIA: Time course analysis of CHANCE. Neurology. 2017 May 16;88(20):1906-1911. doi: 10.1212/WNL.0000000000003941. Epub 2017 Apr 19.

  PMID: 28424269 BACKGROUND

• Li J, Wang A, Zhao X, Liu L, Meng X, Lin J, Jing J, Zou X, Wang Y, Wang Y; CHANCE Investigators. High-sensitive C-reactive protein and dual antiplatelet in intracranial arterial stenosis. Neurology. 2018 Feb 6;90(6):e447-e454. doi: 10.1212/WNL.0000000000004928. Epub 2018 Jan 12.

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• Wang Y, Wang Y, Zhao X, Liu L, Wang D, Wang C, Wang C, Li H, Meng X, Cui L, Jia J, Dong Q, Xu A, Zeng J, Li Y, Wang Z, Xia H, Johnston SC; CHANCE Investigators. Clopidogrel with aspirin in acute minor stroke or transient ischemic attack. N Engl J Med. 2013 Jul 4;369(1):11-9. doi: 10.1056/NEJMoa1215340. Epub 2013 Jun 26.

  PMID: 23803136 RESULT

• Han C, Yang M, Pan Y, Li H, Liu L, Meng X, Wang Y, Wang Y. Disabling Neurologic Deficits and Antiplatelet Therapy in Acute Minor Stroke. J Am Heart Assoc. 2025 Apr 15;14(8):e029734. doi: 10.1161/JAHA.122.029734. Epub 2025 Apr 7.

  PMID: 40194961 DERIVED

• Qiu X, Jiang Y, Gu HQ, Jiang Y, Huang X, Meng X, Wang Y, Li Z. Polygenic Risk Score for the Efficacy of Clopidogrel in Patients With Minor Stroke or Transient Ischemic Attack: A Post Hoc Analysis of the CHANCE Trial. Stroke. 2025 Apr;56(4):818-827. doi: 10.1161/STROKEAHA.124.049140. Epub 2025 Mar 7.

  PMID: 40052280 DERIVED

• Yang M, Xu J, Xue J, Pan Y, Cheng A, Gao F, Meng X, Miao Z, Wang Y, Wang Y; CHANCE Investigators. Efficacy of dual antiplatelet therapy after ischemic stroke according to hsCRP levels and CYP2C19 genotype. Am Heart J. 2025 Feb;280:89-97. doi: 10.1016/j.ahj.2024.10.017. Epub 2024 Nov 12.

  PMID: 39536847 DERIVED

• Qiu X, Zhang Y, Gu H, Jiang Y, Pan Y, Jiang Y, Meng X, Wang Y, Zhao X, Li H, Wang X, Wang Y, Li Z; CHANCE Investigators. Association Between CYP2B6 Polymorphisms and Efficacy of Clopidogrel in Minor Stroke or Transient Ischemic Attack. Stroke. 2023 Jul;54(7):1770-1776. doi: 10.1161/STROKEAHA.122.040507. Epub 2023 Jun 2.

  PMID: 37264909 DERIVED

• Chen P, Wu Q, Xie X, Jing J, Gu H, Wang X, Meng X, Liu L, Wang Y, Wang Y; CHANCE Investigators. Systolic blood pressure and recurrent stroke in patients with different lesion patterns on diffusion weighted imaging. J Clin Hypertens (Greenwich). 2022 Oct;24(10):1350-1357. doi: 10.1111/jch.14543. Epub 2022 Aug 12.

  PMID: 35959564 DERIVED

• Zhang X, Jing J, Zhao X, Liu L, Wang A, Pan Y, Wang D, Johnston SC, Wang Y, Wang Y, Meng X. No rebound effect after a course of clopidogrel in patients with acute TIA or minor stroke. Neurol Res. 2022 Nov;44(11):957-963. doi: 10.1080/01616412.2022.2075660. Epub 2022 Jun 13.

  PMID: 35695332 DERIVED

• Pan Y, Wangqin R, Li H, Jin A, Li J, Lin J, Meng X, Xian Y, Laskowitz DT, Wang Y. LDL-C levels, lipid-lowering treatment and recurrent stroke in minor ischaemic stroke or TIA. Stroke Vasc Neurol. 2022 Aug;7(4):276-284. doi: 10.1136/svn-2021-001317. Epub 2022 Mar 7.

  PMID: 35256525 DERIVED

• Natale P, Palmer SC, Saglimbene VM, Ruospo M, Razavian M, Craig JC, Jardine MJ, Webster AC, Strippoli GF. Antiplatelet agents for chronic kidney disease. Cochrane Database Syst Rev. 2022 Feb 28;2(2):CD008834. doi: 10.1002/14651858.CD008834.pub4.

  PMID: 35224730 DERIVED

• Pan Y, Wangqin R, Li H, Wang Y, Meng X, Johnston SC, Simon T, Lin J, Zhao X, Liu L, Wang D, Wang Y. F2R Polymorphisms and Clopidogrel Efficacy and Safety in Patients With Minor Stroke or TIA. Neurology. 2021 Jan 5;96(1):e1-e9. doi: 10.1212/WNL.0000000000011078. Epub 2020 Oct 22.

  PMID: 33093222 DERIVED

• Wang G, Jing J, Li J, Pan Y, Yan H, Meng X, Zhao X, Liu L, Li H, Wang DZ, Wang Y, Wang Y. Association of elevated hs-CRP and multiple infarctions with outcomes of minor stroke or TIA: subgroup analysis of CHANCE randomised clinical trial. Stroke Vasc Neurol. 2021 Mar;6(1):80-86. doi: 10.1136/svn-2020-000369. Epub 2020 Sep 21.

  PMID: 32958697 DERIVED

• Chen H, Pan Y, Zong L, Jing J, Meng X, Xu Y, Yan H, Zhao X, Liu L, Li H, Johnston SC, Wang Y, Wang Y. Cerebral small vessel disease or intracranial large vessel atherosclerosis may carry different risk for future strokes. Stroke Vasc Neurol. 2020 Jun;5(2):128-137. doi: 10.1136/svn-2019-000305. Epub 2020 Apr 15.

  PMID: 32606085 DERIVED

• Xu YY, Zong LX, Zhang CQ, Pan YS, Jing J, Meng X, Li H, Zhao XQ, Liu LP, Wang D, Wang YL, Wang YJ; CHANCE Investigators. The association of white matter hyperintensities with stroke outcomes and antiplatelet therapy in minor stroke patients. Ann Transl Med. 2020 Mar;8(6):331. doi: 10.21037/atm.2020.02.137.

  PMID: 32355775 DERIVED

• Li J, Wang Y, Li H, Zuo Z, Lin J, Wang A, Zhao X, Liu L, Wang Y; CHANCE Investigators. Homocysteine Level Predicts Response to Dual Antiplatelet in Women With Minor Stroke or Transient Ischemic Attack: Subanalysis of the CHANCE Trial. Arterioscler Thromb Vasc Biol. 2020 Mar;40(3):839-846. doi: 10.1161/ATVBAHA.119.313741. Epub 2020 Jan 16.

  PMID: 31941381 DERIVED

• Yang M, Wang A, Li J, Zhao X, Liu L, Meng X, Jing J, Zhang N, Johnston SC, Wang Y, Wang Y. Lp-PLA2 and dual antiplatelet agents in intracranial arterial stenosis. Neurology. 2020 Jan 14;94(2):e181-e189. doi: 10.1212/WNL.0000000000008733. Epub 2019 Dec 10.

  PMID: 31822574 DERIVED

• Mo J, Chen Z, Xu J, Wang A, Dai L, Cheng A, Meng X, Li H, Wang Y; CHANCE Investigators. Efficacy of Clopidogrel-Aspirin Therapy for Stroke Does Not Exist in CYP2C19 Loss-of-Function Allele Noncarriers With Overweight/Obesity. Stroke. 2020 Jan;51(1):224-231. doi: 10.1161/STROKEAHA.119.026845. Epub 2019 Nov 15.

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  PMID: 25957224 DERIVED

MeSH Terms

Conditions

Stroke; Ischemic Attack, Transient

Interventions

Clopidogrel; Aspirin

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Ischemia

Intervention Hierarchy (Ancestors)

Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Yongjun NA Wang, M.D

  Beijing Tian Tan Hospital, Capital Medical University, Beijing, China

  PRINCIPAL INVESTIGATOR

• S.Claiborne NA Johnston, M.D, Ph.D

  Departments of Neurology, Epidemiology, University of California, San Francisco, USA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Executive Vice-President

Study Record Dates

• First Submitted: September 17, 2009
• First Posted: September 18, 2009
• Study Start: December 1, 2009
• Primary Completion: March 1, 2012
• Study Completion: June 1, 2012
• Last Updated: July 15, 2020

Record last verified: 2020-07

Locations

CN (1)