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Early Antiplatelet for Minor Stroke Following Thrombolysis (EAST)

Primary Purpose

Ischemic Stroke

Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Aspirin 100mg; Clopidogrel 300mg
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 thrombolysis, minor stroke, early antiplatelet

Eligibility Criteria

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

Inclusion Criteria:

  • Age ≥ 18 years old;
  • Acute ischemic stroke patients who received intravenous thrombolysis within 4.5 hours of onset;
  • NIHSS ≤ 5 within 6 hours after the end of intravenous thrombolysis, and no bleeding transformation was found in head CT examination;
  • Premorbid mRS ≤ 1;
  • Signed informed consent.

Exclusion Criteria:

  • Premorbid mRS≥2;
  • Uncontrolled severe hypertension (systolic pressure >180 mmHg or diastolic pressure >110 mmHg after drug treatment);
  • Antithrombotic treatment within 24 hours before randomization;
  • Significant dysphagia and inability to take the experimental drug orally;
  • Allergy or contraindication to study drugs;
  • Comorbidity with any serious diseases and life expectancy is less than half a year;
  • Participating in other clinical trials within three months;
  • Patients not suitable for this clinical study considered by researcher

Sites / Locations

  • Hui-sheng ChenRecruiting
  • Department of Neurology, General Hospital of Northern Theater CommandRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

double antiplatelet group

control group

Arm Description

aspirin 100mg plus clopidogrel 300mg

aspirin placebo plus clopidogrel placebo

Outcomes

Primary Outcome Measures

The proportion of excellent prognosis
excellent prognosis is defined as modified Rankin Score (mRS) 0-1. The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome

Secondary Outcome Measures

The proportion of favorable prognosis
Favorable prognosis is defined as modified Rankin Score (mRS) 0-2. The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome.
Distribution of modified Rankin Score (mRS)
The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome.
Changes in National Institute of Health stroke scale (NIHSS)
the minimum and maximum values of NIHSS are 0 and 42, respectively; higher NIHSS mean a worse outcome.
Occurrence of early neurologyical deterioration (END)
END is defined as more than 2 point increase, but not result of cerebral hemorrhage, compared with baseline at 24 hours
The incidence of symptomatic intracerebral hemorrhage
any evidence of bleeding on the head CT scan associated with clinically significant neurological deterioration (NIHSS score ≥4 points increase)
The incidence of any intracerebral hemorrhage
the evidence of bleeding on the head CT or MRI scan
The incidence of stroke recurrence and other vascular events
The death due to any cause

Full Information

First Posted
December 31, 2021
Last Updated
August 20, 2023
Sponsor
General Hospital of Shenyang Military Region
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1. Study Identification

Unique Protocol Identification Number
NCT05193071
Brief Title
Early Antiplatelet for Minor Stroke Following Thrombolysis (EAST)
Official Title
Early Antiplatelet for Minor Stroke Following Thrombolysis (EAST): a Prospective, Random, Double Blinded and Multi-center Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 8, 2022 (Actual)
Primary Completion Date
July 28, 2024 (Anticipated)
Study Completion Date
July 28, 2024 (Anticipated)

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
The current guideline recommends to give antithrombotic treatment 24 hours after intravenous thrombolysis in acute ischemic stroke. However, early neurological deterioration will occur in some patients due to no antithrombotic treatment, which is closely associated with poor outcome. The current trial aims to investigate the effectiveness and safety of early antithrombotic treatment after intravenous thrombolysis in minor stroke.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke
Keywords
thrombolysis, minor stroke, early antiplatelet

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1022 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
double antiplatelet group
Arm Type
Experimental
Arm Description
aspirin 100mg plus clopidogrel 300mg
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
aspirin placebo plus clopidogrel placebo
Intervention Type
Drug
Intervention Name(s)
Aspirin 100mg; Clopidogrel 300mg
Intervention Description
Aspirin 100mg plus Clopidogrel 300mg will be orally administrated after randomization
Primary Outcome Measure Information:
Title
The proportion of excellent prognosis
Description
excellent prognosis is defined as modified Rankin Score (mRS) 0-1. The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome
Time Frame
Day 90
Secondary Outcome Measure Information:
Title
The proportion of favorable prognosis
Description
Favorable prognosis is defined as modified Rankin Score (mRS) 0-2. The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome.
Time Frame
Day 90
Title
Distribution of modified Rankin Score (mRS)
Description
The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome.
Time Frame
Day 90
Title
Changes in National Institute of Health stroke scale (NIHSS)
Description
the minimum and maximum values of NIHSS are 0 and 42, respectively; higher NIHSS mean a worse outcome.
Time Frame
24 hours, 48 hours, and 10 days
Title
Occurrence of early neurologyical deterioration (END)
Description
END is defined as more than 2 point increase, but not result of cerebral hemorrhage, compared with baseline at 24 hours
Time Frame
24 hours
Title
The incidence of symptomatic intracerebral hemorrhage
Description
any evidence of bleeding on the head CT scan associated with clinically significant neurological deterioration (NIHSS score ≥4 points increase)
Time Frame
36 hours
Title
The incidence of any intracerebral hemorrhage
Description
the evidence of bleeding on the head CT or MRI scan
Time Frame
36 hours
Title
The incidence of stroke recurrence and other vascular events
Time Frame
Day 90
Title
The death due to any cause
Time Frame
Day 90

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years old; Acute ischemic stroke patients who received intravenous thrombolysis within 4.5 hours of onset; NIHSS ≤ 5 within 6 hours after the end of intravenous thrombolysis, and no bleeding transformation was found in head CT examination; Premorbid mRS ≤ 1; Signed informed consent. Exclusion Criteria: Premorbid mRS≥2; Uncontrolled severe hypertension (systolic pressure >180 mmHg or diastolic pressure >110 mmHg after drug treatment); Antithrombotic treatment within 24 hours before randomization; Significant dysphagia and inability to take the experimental drug orally; Allergy or contraindication to study drugs; Comorbidity with any serious diseases and life expectancy is less than half a year; Participating in other clinical trials within three months; Patients not suitable for this clinical study considered by researcher
Facility Information:
Facility Name
Hui-sheng Chen
City
ShenYang
State/Province
None Selected
ZIP/Postal Code
110840
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hui-sheng Chen
Phone
+862428897511
Email
chszh@aliyun.com
Facility Name
Department of Neurology, General Hospital of Northern Theater Command
City
Shenyang
ZIP/Postal Code
110016
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hui-Sheng Chen, Ph.D.
Phone
+86 13352452086
Email
chszh@aliyun.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Early Antiplatelet for Minor Stroke Following Thrombolysis (EAST)

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