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Trial record 1 of 3 for:    Clopidogrel in High-Risk Patients with Acute Nondisabling Cerebrovascular Events
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Clopidogrel in High-risk Patients With Acute Non-disabling Cerebrovascular Events (CHANCE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00979589
Recruitment Status : Completed
First Posted : September 18, 2009
Last Update Posted : July 15, 2020
Sponsor:
Collaborator:
University of California, San Francisco
Information provided by (Responsible Party):
Yongjun Wang, Beijing Tiantan Hospital

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.

Condition or disease Intervention/treatment Phase
Stroke Transient Ischemic Attack Drug: Clopidogrel Drug: Placebo of clopidogrel and Asprin Phase 3

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).

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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




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  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. [ Time Frame: 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 [ Time Frame: 3 months ]
  3. Further efficacy exploratory analysis:Impairment (changes in NIHSS scores at 3 month follow-up). [ Time Frame: 3 months ]
  4. Further efficacy exploratory analysis:Quality of Life (EuroQol EQ-5D scale) [ Time Frame: 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 [ Time Frame: 3 months ]
  6. Severe bleeding incidence (GUSTO definition), including fatal bleeding and symptomatic intracranial hemorrhage. [ Time Frame: 3 months ]
  7. Incidence symptomatic and asymptomatic intracranial hemorrhagic events at 3 months [ Time Frame: 3 months ]
  8. Intracranial hemorrhage [ Time Frame: 3 months ]
  9. Total mortality [ Time Frame: 3 months ]


Information from the National Library of Medicine

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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
Criteria

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

Information from the National Library of Medicine

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


Locations
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China
Beijing Tian Tan Hospital, Capital Medical University
Beijing, China, 100050
Sponsors and Collaborators
Beijing Tiantan Hospital
University of California, San Francisco
Investigators
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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
Publications of Results:
Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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
Keywords provided by Yongjun Wang, Beijing Tiantan Hospital:
stroke
transient ischemic attack
acute treatment
acute non-disabling cerebrovascular event
clopidogrel
clopidogrel combined with ASA
recurrence of stroke and other vascular events
Additional relevant MeSH terms:
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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