Status:
COMPLETED
Efficacy Argatroban in Ischemic Stroke With Early Deterioration (EASE)
Lead Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Conditions:
Acute Progressive Ischemic Stroke
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Acute ischemic stroke (AIS) has the characteristics of high morbidity, high mortality, high disability rate and high recurrence rate. Progressive cerebral infarction (PIS) is a subtype of AIS, account...
Detailed Description
Acute ischemic stroke (AIS) has the characteristics of high morbidity, high mortality, high disability rate and high recurrence rate. Progressive cerebral infarction (PIS) is a subtype of AIS, account...
Eligibility Criteria
Inclusion
- AIS patients with typical symptoms and signs within 48h, including those who received intravenous thrombolysis for 24 hours.
- The neurologic function deteriorated from 6h to 48h after the onset of the disease, and the NIHSS score increased by ≥ 2 points;
- Sign informed consent.
Exclusion
- The diagnosis was cardiogenic cerebral embolism;
- In the patients with large area cerebral infarction of anterior circulation, the focus area was larger than 2 / 3 of the area of cerebral hemisphere;
- Patients with NIHSS score ≥ 21;
- Patients with conversion of intracranial hemorrhage;
- Patients with tirofiban;
- Patients with blood pressure ≥ 180 / 110mmhg after treatment;
- There were severe heart, liver and kidney dysfunction, such as LVEF \< 40%, serum AST and ALT increased to 3 times of the upper limit of normal, creatinine clearance \< 30ml / min;
- Patients with hematological diseases and those with bleeding tendency;
- In the past 6 months, the patients had a history of severe gastrointestinal hemorrhage;
- Allergic to argatraban;
- Patients (such as those with mental and mental disorders) who are not suitable for the clinical study.
Key Trial Info
Start Date :
March 21 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2023
Estimated Enrollment :
628 Patients enrolled
Trial Details
Trial ID
NCT04275180
Start Date
March 21 2020
End Date
January 31 2023
Last Update
April 19 2023
Active Locations (6)
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1
Min Lou
Hangzhou, Zhejiang, China, 310000
2
People's Hospital of Anji
Anji, China
3
Jiaxing Second Hospital
Jiaxing, China
4
Ninghai First Hospital
Ninghai, China