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Antiplatelet vs R-tPA for Acute Mild Ischemic Stroke (ARAMIS)

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. Read our disclaimer for details. Identifier: NCT03661411
Recruitment Status : Completed
First Posted : September 7, 2018
Last Update Posted : August 3, 2022
Information provided by (Responsible Party):
Hui-Sheng Chen, General Hospital of Shenyang Military Region

Brief Summary:

Acute ischemic stroke (AIS) is one of common diseases with significant morbidity, mortality and disability. A wide array of studies confirms that intravenous thrombolytic therapy with alteplase can effectively improve the functional prognosis in acute ischemic stroke. Thus all guidelines recommended the intravenous thrombolytic therapy with alteplase for acute ischemic stroke within 4.5 hours from stroke onset.

Minor stroke is usually defined as NIHSS score ≤ 3 or 5,although it accounts for 1/2-2/3 of AIS, the evidence of thrombolysis is insufficient. A study from Canada shows that 28.5% of patients with minor stroke who have not receive rt-pa thrombolytic therapy are unable to walk independently when discharged. Based on such a consideration,the PRISMS study further compares the efficacy and safety of thrombolytic therapy with antithrombotic therapy in patients with minor stroke. Unfortunately, the study has been early terminated due to the sponsorship reason in 2018, with only 313 cases enrolled. The preliminary results shows that there is no significant difference of the 90-day neurological function between the two groups, while the safety of the treatment group with alteplase has a higher rate of symptomatic intracranial hemorrhage. The patient receiving thrombolysis can not be given antithrombolytic therapy within 24 hours even if the patient's condition has worsened, is clinically more puzzling.

The CHANCE study in 2013 shows that the efficacy of aspirin with clopidogrel is superior to aspirin alone with minor stroke (NIHSS < 3) or TIA(ABCD2 < 4). The POINT study in 2018 further confirmed the efficacy and safety of intensive antithrombotic therapy within 12 hours of onset with minor stroke.

Based on the above discussion, this study aims to explore the efficacy and safety of aspirin with clopidogrel vs alteplase in the treatment of acute minor stroke.

Condition or disease Intervention/treatment Phase
Stroke Drug: Aspirin Drug: Clopidogrel 75mg Drug: Alteplase Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 760 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Antiplatelet vs R-tPA for Acute Mild Ischemic Stroke: a Prospective, Random, Blinded Assessment of Outcome and Open Label Multi-center Study
Actual Study Start Date : October 17, 2018
Actual Primary Completion Date : July 18, 2022
Actual Study Completion Date : July 18, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ischemic Stroke

Arm Intervention/treatment
Experimental: Aspirin+ clopidogrel
aspirin 100mg qd and clopidogrel 75mg(300mg in the first day)qd with a total of 10-14 days, then oral aspirin 100mg or clopidogrel 75mg qd lasting for 90 days.
Drug: Aspirin
100mg qd

Drug: Clopidogrel 75mg
75mg(after first dose of 300mg)qd

Active Comparator: Alteplase
intravenous alteplase (0.9 mg/kg and maximal dose of 90 mg) was given, and followed by antithrombotic protocol 24 hours after thrombolysis based on clinical guideline.
Drug: Alteplase
Iv at 0.9 milligrams per kilogram (mg/kg)

Primary Outcome Measures :
  1. Proportion of mRS (0-1) [ Time Frame: 90±7 days ]

Secondary Outcome Measures :
  1. Proportion of mRS (0-2) [ Time Frame: 90±7 days ]
  2. change in NIH Stroke Scale score compared with baseline [ Time Frame: 24 hours ]
  3. incidence of early neurological improvement [ Time Frame: 24 hours ]
    more than 2 NIH Stroke Scale score decrease compared with baseline

  4. Incidence of early neurological deterioration [ Time Frame: 7 days ]
    more than 2 NIH Stroke Scale score increase (not result of cerebral hemorrhage) compared with baseline

  5. occurrence of stroke or other vascular events [ Time Frame: 90±7 days ]
  6. proportion of death of any cause [ Time Frame: 90±7 days ]
  7. occurrence of symptomatic intracranial hemorrhage [ Time Frame: 90±7 days ]
    more than 4 NIHSS score increase caused by intracranial hemorrhage

  8. proportion of any bleeding events [ Time Frame: 90±7 days ]

Information from the National Library of Medicine

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

Inclusion Criteria:

  1. Patient age ≥18 years;
  2. Study treatment can be started within 4.5h;
  3. Ischemic stroke confirmed by head CT or MRI;
  4. NIHSS score ≤ 5, and ≤ 1 NIHSS score in single item scores such as vision, language, neglect and single limb and no score in consciousness item;
  5. Premorbid mRS ≤ 1;
  6. Signed informed consent

Exclusion Criteria:

  1. Serious neurological deficits before onset ( mRS ≥ 2);
  2. Obvious head injuries or strokes within 3 months;
  3. Subarachnoid hemorrhage;
  4. History of intracranial hemorrhage;
  5. Intracranial tumor, arteriovenous malformation or aneurysm;
  6. Intracranial or spinal cord surgery within 3 months;
  7. Arterial puncture at a noncompressible site within the previous seven days;
  8. Gastrointestinal or urinary tract hemorrhage within the previous 21 days;
  9. Major surgery within 1 month;
  10. Systolic pressure ≥180 mmHg or diastolic pressure ≥110 mmHg;
  11. Blood glucose < 50 mg/dl (2.7mmol/L);
  12. Heparin therapy or oral anticoagulation therapy within 48 hours;
  13. Platelet count of <100,000/mm3 (This does not need to be verified prior to randomization if clinical abnormality is not suspected);
  14. Oral warfarin is being taken and INR>1.6;
  15. Abnormal APTT;
  16. Pregnancy;
  17. Neurological deficit after epileptic seizures;
  18. Myocardial infarction within 3 months;
  19. Cerebral infarction with definite anticoagulation indications, such as cerebral infarction caused by cardiogenic embolism;
  20. Oral administration is not allowed due to dysphagia;
  21. allergy to study drugs;
  22. Other serious illness that would confound the clinical outcome at 90 days;
  23. Participating in other clinical trials within 3 months;
  24. patients not suitable for this clinical studies considered by researcher;

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 identifier (NCT number): NCT03661411

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Lin Tao
ShenYang, China
Sponsors and Collaborators
General Hospital of Shenyang Military Region
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Study Chair: Huisheng Chen, Doctor Neurology Department
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Responsible Party: Hui-Sheng Chen, Director, General Hospital of Shenyang Military Region Identifier: NCT03661411    
Other Study ID Numbers: k(2018)22-1
First Posted: September 7, 2018    Key Record Dates
Last Update Posted: August 3, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ischemic Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Tissue Plasminogen Activator
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
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
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents