Antiplatelet Therapy in Acute Mild-Moderate Ischemic Stroke

  • STATUS
    Recruiting
  • End date
    Apr 30, 2022
  • participants needed
    3000
  • sponsor
    General Hospital of Shenyang Military Region
Updated on 15 February 2021
aspirin
stroke
clopidogrel
deficit
transient ischemic attack

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.

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.

Details
Condition Ischemic Stroke
Treatment Clopidogrel, Aspirin
Clinical Study IdentifierNCT02869009
SponsorGeneral Hospital of Shenyang Military Region
Last Modified on15 February 2021

Eligibility

Yes No Not Sure

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 (mRS1)
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
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

0/250
Preferred Language
Other Language
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note