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StrokePhase 3CHANCENCT00979589

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

A Phase 3 study testing Clopidogrel in people with Stroke and Transient Ischemic Attack, run by Beijing Tiantan Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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)… Read more about this study

Who is it for?
Ages 40 to 90 years
Conditions the study is for
Stroke, Transient Ischemic Attack
What is being tested?
Clopidogrel
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
5,100 participants
Where
1 siteChina
Study dates
Dec 2009to Jun 2012
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 40 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 25Show fewer
  • 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
  • History of intracranial hemorrhage
  • Anticipated requirement for long-term non-study antiplatelet drugs, or NSAIDs affecting platelet function
  • Current treatment (last dose given within 10 days before randomization) with heparin therapy or oral anti coagulation
  • Gastrointestinal bleed or major surgery within 3 months
  • Planned or likely revascularization (any angioplasty or vascular surgery) within the next 3 months (if clinically indicated, vascular imaging should be performed prior to randomization whenever possible)
  • Scheduled for surgery or interventional treatment requiring study drug cessation
  • Qualifying TIA or minor stroke induced by angiography or surgery
  • Severe non-cardiovascular comorbidity with life expectancy < 3 months
  • Women of childbearing age not practicing reliable contraception who do not have a documented negative pregnancy test
  • Currently receiving an investigational drug or device

Trial locations and contacts

1 site in 1 country.

China1 site
  • Beijing Tian Tan Hospital, Capital Medical University

    Beijing, 100050

Other trials in China

About this study

Official title: Randomized,Double-blind Trial Comparing the Effects of a 3-month Clopidogrel Regimen,Combined With ASA During the First 21days,Versus ASA Alone for the Acute Treatment of TIA or Minor Stroke

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.

Read the detailed description

Inclusion criteria:

  1. Adult subjects (male or female ≥ 40 years)
  2. 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.
  3. 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.
  4. Informed consent signed

Primary Efficacy Endpoint:

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

Being tested
Clopidogrel, Placebo of clopidogrel and Asprin
Keywords
stroke, transient ischemic attack, acute treatment, acute non-disabling cerebrovascular event, clopidogrel, clopidogrel combined with ASA, recurrence of stroke and other vascular events
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.

  • ClopidogrelDrug

    Also called Plavix

    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.

  • Placebo of clopidogrel and AsprinDrug

    Also called Acetylsalicylic acid

    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.

Study groups in NCT00979589
Study groupRoleWhat they receive
Combination Clopidogrel and asprinActive comparatorNot described
Receives: Drug: Clopidogrel
Asprin and placeboPlacebo comparatorNot described
Receives: Drug: Placebo of clopidogrel and Asprin

What is being measured

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

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

    Measured: 3 months

Secondary outcomes (9)
  1. 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.

    Measured: 3 months

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

    Measured: 3 months

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

    Measured: 3 months

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

    Measured: 3 months

  5. 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

    Measured: 3 months

  6. Severe bleeding incidence (GUSTO definition), including fatal bleeding and symptomatic intracranial hemorrhage.

    Measured: 3 months

  7. Incidence symptomatic and asymptomatic intracranial hemorrhagic events at 3 months

    Measured: 3 months

  8. Intracranial hemorrhage

    Measured: 3 months

  9. Total mortality

    Measured: 3 months

Timeline

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

  1. First posted18 Sep 2009 (estimated)
  2. Study startDec 2009
  3. Primary completionMar 2012
  4. Study completionJun 2012

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
5,100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00979589
Sponsor's protocol ID
2008ZX09312-008
Acronym
CHANCE
Status last verified
Jul 2020
First submitted
17 Sep 2009
Last updated
15 Jul 2020
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 20826243
  • 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.

    PubMed 27348249
  • 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.

    PubMed 29582084
  • 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.

    PubMed 31424481
  • 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.

    PubMed 28202699
  • 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.

    PubMed 28424269
  • 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.

    PubMed 29330312
  • 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.

    PubMed 23803136
  • 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.

    PubMed 40194961
  • 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.

    PubMed 40052280
  • 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.

    PubMed 39536847
  • 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.

    PubMed 37264909
  • 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.

    PubMed 35959564
  • 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.

    PubMed 35695332
  • 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.

    PubMed 35256525

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Clopidogrel in people with Stroke and Transient Ischemic Attack, run by Beijing Tiantan Hospital at 1 site 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 4 inclusion and 25 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: finished, as of the sponsor's last update on 15 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Percentage of patients with the 3-month new vascular events, defined as any event of the following: Any stroke (ischemic or hemorrhage) (time frame: 3 months). 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 NCT00979589, which also lists 42 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 15 Jul 2020.

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