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

Primary Purpose

Ischemic Stroke

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
clopidogrel
Aspirin
Sponsored by
General Hospital of Shenyang Military Region
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Stroke focused on measuring stroke, clopidogrel, antiplatelets

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • General Hospital of Shenyang Military Region

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

clopidogrel plus aspirin group

aspirin group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Early neurological deterioration assessed as change of NIHSS

Secondary Outcome Measures

new clinical vascular events (ischemic stroke/hemorrhagic stroke/TIA/myocardial infarction/vascular death)
Changes in National Institute of Health stroke scale scores
moderate to severe bleeding events
cerebral hemorrhage，hemorrhage of digestive tract, or moderate to severe bleeding of other organs.
Total mortality
Adverse events/severe adverse events

Full Information

First Posted
August 1, 2016
Last Updated
December 3, 2022
Sponsor
General Hospital of Shenyang Military Region
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1. Study Identification

Unique Protocol Identification Number
NCT02869009
Brief Title
Antiplatelet Therapy in Acute Mild-Moderate Ischemic Stroke
Acronym
ATAMIS
Official Title
Antiplatelet Therapy in Acute Mild-Moderate Ischemic Stroke (ATAMIS): a Parallel Randomized, Open-label, Multicenter, Prospective Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
November 2016 (Actual)
Primary Completion Date
October 31, 2022 (Actual)
Study Completion Date
October 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
General Hospital of Shenyang Military Region

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke
Keywords
stroke, clopidogrel, antiplatelets

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3000 (Actual)

8. Arms, Groups, and Interventions

Arm Title
clopidogrel plus aspirin group
Arm Type
Experimental
Arm Description
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.
Arm Title
aspirin group
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
clopidogrel
Other Intervention Name(s)
Plavix
Intervention Type
Drug
Intervention Name(s)
Aspirin
Primary Outcome Measure Information:
Title
Early neurological deterioration assessed as change of NIHSS
Time Frame
14 days
Secondary Outcome Measure Information:
Title
new clinical vascular events (ischemic stroke/hemorrhagic stroke/TIA/myocardial infarction/vascular death)
Time Frame
90 days
Title
Changes in National Institute of Health stroke scale scores
Time Frame
14 days
Title
moderate to severe bleeding events
Description
cerebral hemorrhage，hemorrhage of digestive tract, or moderate to severe bleeding of other organs.
Time Frame
14 days
Title
Total mortality
Time Frame
90 days
Title
Adverse events/severe adverse events
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hui-Sheng Chen
Organizational Affiliation
General Hospital of Shenyang Military Region
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Xin-Hong Wang
Organizational Affiliation
General Hospital of Shenyang Military Region
Official's Role
Principal Investigator
Facility Information:
Facility Name
General Hospital of Shenyang Military Region
City
Shenyang
State/Province
Liaoning
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23803136
Citation
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Results Reference
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20335070
Citation
Wong KS, Chen C, Fu J, Chang HM, Suwanwela NC, Huang YN, Han Z, Tan KS, Ratanakorn D, Chollate P, Zhao Y, Koh A, Hao Q, Markus HS; CLAIR study investigators. Clopidogrel plus aspirin versus aspirin alone for reducing embolisation in patients with acute symptomatic cerebral or carotid artery stenosis (CLAIR study): a randomised, open-label, blinded-endpoint trial. Lancet Neurol. 2010 May;9(5):489-97. doi: 10.1016/S1474-4422(10)70060-0. Epub 2010 Mar 22.
Results Reference
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PubMed Identifier
17931979
Citation
Kennedy J, Hill MD, Ryckborst KJ, Eliasziw M, Demchuk AM, Buchan AM; FASTER Investigators. Fast assessment of stroke and transient ischaemic attack to prevent early recurrence (FASTER): a randomised controlled pilot trial. Lancet Neurol. 2007 Nov;6(11):961-9. doi: 10.1016/S1474-4422(07)70250-8. Epub 2007 Oct 10.
Results Reference
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PubMed Identifier
15851601
Citation
Markus HS, Droste DW, Kaps M, Larrue V, Lees KR, Siebler M, Ringelstein EB. Dual antiplatelet therapy with clopidogrel and aspirin in symptomatic carotid stenosis evaluated using doppler embolic signal detection: the Clopidogrel and Aspirin for Reduction of Emboli in Symptomatic Carotid Stenosis (CARESS) trial. Circulation. 2005 May 3;111(17):2233-40. doi: 10.1161/01.CIR.0000163561.90680.1C. Epub 2005 Apr 25.
Results Reference
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PubMed Identifier
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Citation
Bhatt DL, Fox KA, Hacke W, Berger PB, Black HR, Boden WE, Cacoub P, Cohen EA, Creager MA, Easton JD, Flather MD, Haffner SM, Hamm CW, Hankey GJ, Johnston SC, Mak KH, Mas JL, Montalescot G, Pearson TA, Steg PG, Steinhubl SR, Weber MA, Brennan DM, Fabry-Ribaudo L, Booth J, Topol EJ; CHARISMA Investigators. Clopidogrel and aspirin versus aspirin alone for the prevention of atherothrombotic events. N Engl J Med. 2006 Apr 20;354(16):1706-17. doi: 10.1056/NEJMoa060989. Epub 2006 Mar 12.
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Citation
Diener HC, Bogousslavsky J, Brass LM, Cimminiello C, Csiba L, Kaste M, Leys D, Matias-Guiu J, Rupprecht HJ; MATCH investigators. Aspirin and clopidogrel compared with clopidogrel alone after recent ischaemic stroke or transient ischaemic attack in high-risk patients (MATCH): randomised, double-blind, placebo-controlled trial. Lancet. 2004 Jul 24-30;364(9431):331-7. doi: 10.1016/S0140-6736(04)16721-4.
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Results Reference
derived

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Antiplatelet Therapy in Acute Mild-Moderate Ischemic Stroke

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