Clopidogrel in High-risk Patients With Acute Non-disabling Cerebrovascular Events (CHANCE)
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ClinicalTrials.gov Identifier: NCT00979589 |
Recruitment Status :
Completed
First Posted : September 18, 2009
Last Update Posted : July 15, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Stroke Transient Ischemic Attack | Drug: Clopidogrel Drug: Placebo of clopidogrel and Asprin | Phase 3 |
Inclusion criteria:
- 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
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).
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 5100 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
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 |
Study Start Date : | December 2009 |
Actual Primary Completion Date : | March 2012 |
Actual Study Completion Date : | June 2012 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Combination Clopidogrel and asprin |
Drug: Clopidogrel
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.
Other Name: Plavix |
Placebo Comparator: Asprin and placebo |
Drug: Placebo of clopidogrel and Asprin
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.
Other Name: Acetylsalicylic acid |
- 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 ]
- 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. [ Time Frame: 3 months ]
- Modified Rankin Scale score changes (continuous) and dichotomized at percentage with score 0-2 vs. 3-6 at 3 month follow-up [ Time Frame: 3 months ]
- Further efficacy exploratory analysis:Impairment (changes in NIHSS scores at 3 month follow-up). [ Time Frame: 3 months ]
- Further efficacy exploratory analysis:Quality of Life (EuroQol EQ-5D scale) [ Time Frame: 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 [ Time Frame: 3 months ]
- Severe bleeding incidence (GUSTO definition), including fatal bleeding and symptomatic intracranial hemorrhage. [ Time Frame: 3 months ]
- Incidence symptomatic and asymptomatic intracranial hemorrhagic events at 3 months [ Time Frame: 3 months ]
- Intracranial hemorrhage [ Time Frame: 3 months ]
- Total mortality [ Time Frame: 3 months ]

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Ages Eligible for Study: | 40 Years to 90 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
- 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
Exclusion Criteria:
- 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
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00979589
China | |
Beijing Tian Tan Hospital, Capital Medical University | |
Beijing, China, 100050 |
Principal Investigator: | 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 |
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Yongjun Wang, Executive Vice-President, Beijing Tiantan Hospital |
ClinicalTrials.gov Identifier: | NCT00979589 |
Other Study ID Numbers: |
2008ZX09312-008 |
First Posted: | September 18, 2009 Key Record Dates |
Last Update Posted: | July 15, 2020 |
Last Verified: | July 2020 |
stroke transient ischemic attack acute treatment acute non-disabling cerebrovascular event |
clopidogrel clopidogrel combined with ASA recurrence of stroke and other vascular events |
Cerebrovascular Disorders Clopidogrel Stroke Ischemic Attack, Transient Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases Brain Ischemia Aspirin Platelet Aggregation Inhibitors Purinergic P2Y Receptor Antagonists Purinergic P2 Receptor Antagonists Purinergic Antagonists |
Purinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Anti-Inflammatory Agents Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents Cyclooxygenase Inhibitors Enzyme Inhibitors |