Clinical Study of Argatroban in the Treatment of Acute Progressive Ischemic Stroke

• Status: Recruiting
• Trial end date: 2022-03-31
• Target enrollment: 0
• Participant gender: All

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, accounting for 10% - 40%. Because of the gradual aggravation of neurological deficit symptoms, it has a higher rate of disability and death, which brings heavy mental and economic burden to families, society and the country.

The progress of acute cerebral infarction is generally within 6 hours to 1 week after the onset of the disease. At present, it is considered that thrombus prolongation is one of the important pathogenesis of PIS. Heparin can reduce the incidence of post-stroke embolism, but its benefits are offset by the risk of hemorrhage due to the high risk of hemorrhage. The 2013AHA guidelines in the United States do not recommend it as a routine anticoagulant therapy. Therefore, reducing the risk of bleeding is the key to the anticoagulation therapy of PIS.

Argatroban is a new thrombin inhibitor. Its mechanism of action is to bind and inactivate thrombin (factor Ⅱ a) directly.Compared with traditional anticoagulants, argatroban not only has the advantages of good anticoagulant effect and rapid onset, but also has high safety. Therefore, this study aims to verify the clinical efficacy of Argatroban in the treatment of PIS in a large population.

In this study, 628 patients are expected to be enrolled into the study group. The experimental group and the control group are selected by dynamic random method. Both groups are given standard medical treatment, including routine antiplatelet, blood pressure control, statins to stabilize plaque, etc. The control group is only given standard medical treatment. In the experimental group, Argatroban is used on the basis of standard medical treatment. Both groups are treated for 7 days, and the second-class prevention standard medical treatment is given from the 8th to the 90th day. The main outcome measure is the good prognosis rate at the third month after PIS. The good prognosis was defined as the modified Rankin Scale (mRS) ≤ 3.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Treatments: Argatroban

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.