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

December 3, 2022 updated by: Hui-Sheng Chen, General Hospital of Shenyang Military Region

Antiplatelet Therapy in Acute Mild-Moderate Ischemic Stroke (ATAMIS): a Parallel Randomized, Open-label, Multicenter, Prospective Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

3000

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Liaoning
      • Shenyang, Liaoning, China
        • General Hospital of Shenyang Military Region

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: Aspirin
Drug: clopidogrel
Other Names:
  • Plavix
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.
Drug: Aspirin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Early neurological deterioration assessed as change of NIHSS
Time Frame: 14 days
14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
new clinical vascular events (ischemic stroke/hemorrhagic stroke/TIA/myocardial infarction/vascular death)
Time Frame: 90 days
90 days
Changes in National Institute of Health stroke scale scores
Time Frame: 14 days
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.
14 days
Total mortality
Time Frame: 90 days
90 days
Adverse events/severe adverse events
Time Frame: 90 days
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

General Hospital of Shenyang Military Region

Investigators

  • Principal Investigator: Xin-Hong Wang, General Hospital of Shenyang Military Region

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2016

Primary Completion (Actual)

October 31, 2022

Study Completion (Actual)

October 31, 2022

Study Registration Dates

First Submitted

August 1, 2016

First Submitted That Met QC Criteria

August 11, 2016

First Posted (Estimate)

August 16, 2016

Study Record Updates

Last Update Posted (Estimate)

December 7, 2022

Last Update Submitted That Met QC Criteria

December 3, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • k2016-06

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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