Early Antiplatelet for Minor Stroke Following Thrombolysis (EAST)

Ischemic Stroke Clinical Trial

Official title:

Early Antiplatelet for Minor Stroke Following Thrombolysis (EAST): a Prospective, Random, Double Blinded and Multi-center Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05193071
• Other study ID #: y (2021) 109
• Status: Recruiting
• Phase: Phase 4
• Start date: July 8, 2022
• Est. completion date: July 28, 2024

Study information

• Verified date: August 2023
• Source: General Hospital of Shenyang Military Region
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1022
• Est. completion date: July 28, 2024
• Est. primary completion date: July 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ischemic Stroke
• Stroke

Intervention

Drug:
• Aspirin 100mg; Clopidogrel 300mg
Aspirin 100mg plus Clopidogrel 300mg will be orally administrated after randomization

Locations

Country	Name	City	State
China	Department of Neurology, General Hospital of Northern Theater Command	Shenyang
China	Hui-sheng Chen	ShenYang	None Selected

Sponsors (1)

Lead Sponsor	Collaborator
General Hospital of Shenyang Military Region

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Day 90
Secondary	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.	Day 90
Secondary	Distribution of modified Rankin Score (mRS)	The minimum and maximum values of mRS are 0 and 6, respectively; higher score mean a worse outcome.	Day 90
Secondary	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.	24 hours, 48 hours, and 10 days
Secondary	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	24 hours
Secondary	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)	36 hours
Secondary	The incidence of any intracerebral hemorrhage	the evidence of bleeding on the head CT or MRI scan	36 hours
Secondary	The incidence of stroke recurrence and other vascular events		Day 90
Secondary	The death due to any cause		Day 90