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Antiplatelet Therapy in Acute Mild-Moderate Ischemic Stroke (ATAMIS)

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ClinicalTrials.gov Identifier: NCT02869009
Recruitment Status : Recruiting
First Posted : August 16, 2016
Last Update Posted : December 5, 2018
Sponsor:
Information provided by (Responsible Party):
Hui-Sheng Chen, General Hospital of Shenyang Military Region

Tracking Information
First Submitted Date  ICMJE August 1, 2016
First Posted Date  ICMJE August 16, 2016
Last Update Posted Date December 5, 2018
Study Start Date  ICMJE November 2016
Estimated Primary Completion Date December 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 1, 2016)
Early neurological deterioration assessed as change of NIHSS [ Time Frame: 14 days ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 11, 2016)
Early neurological deterioration assessed as no change of NIHSS [ Time Frame: 14 days ]
Early neurological deterioration assessed as no change of the National Institute of Health Stroke Scale (NIHSS) in 14 days
Change History Complete list of historical versions of study NCT02869009 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 11, 2016)
  • new clinical vascular events (ischemic stroke/hemorrhagic stroke/TIA/myocardial infarction/vascular death) [ Time Frame: 90 days ]
  • Changes in National Institute of Health stroke scale scores [ Time Frame: 14 days ]
  • moderate to severe bleeding events [ Time Frame: 14 days ]
    cerebral hemorrhage,hemorrhage of digestive tract, or moderate to severe bleeding of other organs.
  • Total mortality [ Time Frame: 90 days ]
  • Adverse events/severe adverse events [ Time Frame: 90 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Antiplatelet Therapy in Acute Mild-Moderate Ischemic Stroke
Official Title  ICMJE Antiplatelet Therapy in Acute Mild-Moderate Ischemic Stroke (ATAMIS): a Parallel Randomized, Open-label, Multicenter, Prospective Study
Brief Summary The risk of early recurrence or progression of acute ischemic stroke is very high, even in patients treated with aspirin. The Chance study show that clopidogrel plus aspirin treatment reduced the risk of recurrent stroke in patients with transient ischemic attack (TIA) or minor ischemic stroke (NIHSS ≤ 3) within 24 hour onset and was not associated with increased hemorrhage events, compared with aspirin monotherapy. However, it is not known whether the dual antiplatelet treatment could reduce the risk of early recurrence or progression in patients with acute mild to moderate ischemic stroke (4 ≤ NIHSS ≤ 10). The investigators hypothesise that clopidogrel-aspirin treatment will be superior to aspirin monotherapy in this group of patients.
Detailed Description

The ATAMIS study is a multicentre, prospective, randomised, open-label, controlled trial with a target enrollment of 3,000 patients from 60 centres of the Northeast China. Eligible patients are as follows: (1) definite acute ischemic stroke; (2) neurological deficit: 4 ≤ NIHSS ≤ 10; (3) time from onset to drug treatment: within 48 hours.

Patients in the clopidogrel-aspirin group will receive a 300mg loading dose of clopidogrel, followed by clopidogrel 75 mg/d and aspirin 75 mg/d from day 2 to day 14, and followed by clopidogrel 75 mg/d or aspirin 100 mg/d from day 15 to day 90.

Patients in the aspirin-alone group will receive 100-300 mg aspirin from day 1 to day 14, followed by aspirin 100 mg/d from day 15 to day 90.

The primary efficacy end point is early neurological deterioration assessed as a change of NIHSS: no change of NIHSS within 14 days.

Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Ischemic Stroke
Intervention  ICMJE
  • Drug: clopidogrel
    Other Name: Plavix
  • Drug: Aspirin
Study Arms  ICMJE
  • Experimental: clopidogrel plus aspirin group
    the group will receive a 300mg loading dose of clopidogrel plus aspirin 100 mg, followed by clopidogrel 75 mg/d and aspirin 100 mg/d from day 2 to day 14, and followed by clopidogrel 75 mg/d or aspirin 100 mg/d from day 15 to day 90.
    Interventions:
    • Drug: clopidogrel
    • Drug: Aspirin
  • Experimental: aspirin group
    the group will receive 100-300 mg aspirin from day 1 to day 14, followed by aspirin 100 mg/d from day 15 to day 90.
    Intervention: Drug: Aspirin
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 11, 2016)
3000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 30, 2020
Estimated Primary Completion Date December 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age ≥ 18 years
  • Acute ischemic stroke that can be randomized within 48 hours of symptoms onset
  • neurological deficit: 4 ≤ NIHSS ≤ 10
  • CT or MRI scan ruling out hemorrhage or other pathology
  • the first onset of ischemic stroke or previous stroke with no obvious sequelae (mRS≤1)
  • Signed informed consent by patient self or legally authorized representatives

Exclusion Criteria:

  • intracranial hemorrhage and hemorrhagic cerebral infarction
  • Thrombolysis for ischemic stroke
  • Allergy to clopidogrel and/or aspirin
  • History of stroke with serious sequelae
  • Severe systemic disease (such as severe infection, severe hepatic and renal dysfunction)
  • Clear indication for anticoagulation (atrial fibrillation, mechanical cardiac valves, deep venous thrombosis, pulmonary embolism)
  • History of intracranial hemorrhage
  • Planned treatment with nonsteroidal anti-inflammatory drugs to affect platelet function
  • Anticoagulation within 10 days
  • Gastrointestinal bleed or major surgery within 3 months
  • Planned or likely revascularization (any angioplasty or vascular surgery) within the next 3 months
  • Planned surgery or intervention to stop antiplatelet therapy
  • Ischemic stroke induced by angiography or surgery
  • Pregnancy or childbirth within the previous 4 weeks
  • Patients who have been treated with any other investigational drug within 3 months of enrollment
  • Severe noncardiovascular comorbidity with life expectancy <3 months
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Hui-Sheng Chen 86-24-28897511 chszh@aliyun.com
Contact: Xin-Hong Wang 86-15309885658 450341972@qq.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02869009
Other Study ID Numbers  ICMJE k2016-06
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Hui-Sheng Chen, General Hospital of Shenyang Military Region
Study Sponsor  ICMJE General Hospital of Shenyang Military Region
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Hui-Sheng Chen General Hospital of Shenyang Military Region
Principal Investigator: Xin-Hong Wang General Hospital of Shenyang Military Region
PRS Account General Hospital of Shenyang Military Region
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP