Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 6 of 459 for:    ASPIRIN AND clopidogrel AND ischemic

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

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
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

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.

Condition or disease Intervention/treatment Phase
Ischemic Stroke Drug: clopidogrel Drug: Aspirin Early Phase 1

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Antiplatelet Therapy in Acute Mild-Moderate Ischemic Stroke (ATAMIS): a Parallel Randomized, Open-label, Multicenter, Prospective Study
Study Start Date : November 2016
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : April 30, 2020

Resource links provided by the National Library of Medicine


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: clopidogrel
Other Name: Plavix

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.
Drug: Aspirin



Primary Outcome Measures :
  1. Early neurological deterioration assessed as change of NIHSS [ Time Frame: 14 days ]

Secondary Outcome Measures :
  1. new clinical vascular events (ischemic stroke/hemorrhagic stroke/TIA/myocardial infarction/vascular death) [ Time Frame: 90 days ]
  2. Changes in National Institute of Health stroke scale scores [ Time Frame: 14 days ]
  3. moderate to severe bleeding events [ Time Frame: 14 days ]
    cerebral hemorrhage,hemorrhage of digestive tract, or moderate to severe bleeding of other organs.

  4. Total mortality [ Time Frame: 90 days ]
  5. Adverse events/severe adverse events [ Time Frame: 90 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT02869009


Contacts
Layout table for location contacts
Contact: Hui-Sheng Chen 86-24-28897511 chszh@aliyun.com
Contact: Xin-Hong Wang 86-15309885658 450341972@qq.com

Locations
Layout table for location information
China, Liaoning
General Hospital of Shenyang Military Region Recruiting
Shenyang, Liaoning, China
Contact: Hui-Sheng Chen    86-24-28897511    chszh@aliyun.com   
Contact: Xin-hong Wang    86-15309885658    450341972@qq.com   
Sponsors and Collaborators
General Hospital of Shenyang Military Region
Investigators
Layout table for investigator information
Study Director: Hui-Sheng Chen General Hospital of Shenyang Military Region
Principal Investigator: Xin-Hong Wang General Hospital of Shenyang Military Region

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Hui-Sheng Chen, Director of neurological department, General Hospital of Shenyang Military Region
ClinicalTrials.gov Identifier: NCT02869009     History of Changes
Other Study ID Numbers: k2016-06
First Posted: August 16, 2016    Key Record Dates
Last Update Posted: December 5, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Hui-Sheng Chen, General Hospital of Shenyang Military Region:
stroke
clopidogrel
antiplatelets

Additional relevant MeSH terms:
Layout table for MeSH terms
Ischemia
Brain Ischemia
Aspirin
Clopidogrel
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Purinergic P2Y Receptor Antagonists