Clinical Study of Argatroban in the Treatment of Acute Progressive Ischemic Stroke
Status:
Recruiting
Trial end date:
2022-03-31
Target enrollment:
Participant gender:
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
Details
Lead Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University