search
Back to results

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

Primary Purpose

Stroke

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Aspirin
Clopidogrel 75mg
Alteplase
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 Stroke

Eligibility Criteria

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

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;

Sites / Locations

  • Lin Tao

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Aspirin+ clopidogrel

Alteplase

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Proportion of mRS (0-1)

Secondary Outcome Measures

Proportion of mRS (0-2)
change in NIH Stroke Scale score compared with baseline
incidence of early neurological improvement
more than 2 NIH Stroke Scale score decrease compared with baseline
Incidence of early neurological deterioration
more than 2 NIH Stroke Scale score increase (not result of cerebral hemorrhage) compared with baseline
occurrence of stroke or other vascular events
proportion of death of any cause
occurrence of symptomatic intracranial hemorrhage
more than 4 NIHSS score increase caused by intracranial hemorrhage
proportion of any bleeding events

Full Information

First Posted
September 5, 2018
Last Updated
August 1, 2022
Sponsor
General Hospital of Shenyang Military Region
search

1. Study Identification

Unique Protocol Identification Number
NCT03661411
Brief Title
Antiplatelet vs R-tPA for Acute Mild Ischemic Stroke
Acronym
ARAMIS
Official Title
Antiplatelet vs R-tPA for Acute Mild Ischemic Stroke: a Prospective, Random, Blinded Assessment of Outcome and Open Label Multi-center Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
October 17, 2018 (Actual)
Primary Completion Date
July 18, 2022 (Actual)
Study Completion Date
July 18, 2022 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
760 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aspirin+ clopidogrel
Arm Type
Experimental
Arm Description
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.
Arm Title
Alteplase
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Aspirin
Intervention Description
100mg qd
Intervention Type
Drug
Intervention Name(s)
Clopidogrel 75mg
Intervention Description
75mg(after first dose of 300mg)qd
Intervention Type
Drug
Intervention Name(s)
Alteplase
Intervention Description
Iv at 0.9 milligrams per kilogram (mg/kg)
Primary Outcome Measure Information:
Title
Proportion of mRS (0-1)
Time Frame
90±7 days
Secondary Outcome Measure Information:
Title
Proportion of mRS (0-2)
Time Frame
90±7 days
Title
change in NIH Stroke Scale score compared with baseline
Time Frame
24 hours
Title
incidence of early neurological improvement
Description
more than 2 NIH Stroke Scale score decrease compared with baseline
Time Frame
24 hours
Title
Incidence of early neurological deterioration
Description
more than 2 NIH Stroke Scale score increase (not result of cerebral hemorrhage) compared with baseline
Time Frame
7 days
Title
occurrence of stroke or other vascular events
Time Frame
90±7 days
Title
proportion of death of any cause
Time Frame
90±7 days
Title
occurrence of symptomatic intracranial hemorrhage
Description
more than 4 NIHSS score increase caused by intracranial hemorrhage
Time Frame
90±7 days
Title
proportion of any bleeding events
Time Frame
90±7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient age ≥18 years; Study treatment can be started within 4.5h; Ischemic stroke confirmed by head CT or MRI; 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; Premorbid mRS ≤ 1; Signed informed consent Exclusion Criteria: Serious neurological deficits before onset ( mRS ≥ 2); Obvious head injuries or strokes within 3 months; Subarachnoid hemorrhage; History of intracranial hemorrhage; Intracranial tumor, arteriovenous malformation or aneurysm; Intracranial or spinal cord surgery within 3 months; Arterial puncture at a noncompressible site within the previous seven days; Gastrointestinal or urinary tract hemorrhage within the previous 21 days; Major surgery within 1 month; Systolic pressure ≥180 mmHg or diastolic pressure ≥110 mmHg; Blood glucose < 50 mg/dl (2.7mmol/L); Heparin therapy or oral anticoagulation therapy within 48 hours; Platelet count of <100,000/mm3 (This does not need to be verified prior to randomization if clinical abnormality is not suspected); Oral warfarin is being taken and INR>1.6; Abnormal APTT; Pregnancy; Neurological deficit after epileptic seizures; Myocardial infarction within 3 months; Cerebral infarction with definite anticoagulation indications, such as cerebral infarction caused by cardiogenic embolism; Oral administration is not allowed due to dysphagia; allergy to study drugs; Other serious illness that would confound the clinical outcome at 90 days; Participating in other clinical trials within 3 months; patients not suitable for this clinical studies considered by researcher;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huisheng Chen, Doctor
Organizational Affiliation
Neurology Department
Official's Role
Study Chair
Facility Information:
Facility Name
Lin Tao
City
ShenYang
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Antiplatelet vs R-tPA for Acute Mild Ischemic Stroke

We'll reach out to this number within 24 hrs