Argatroban Plus R-tPA for Acute Ischemic Stroke

General Hospital of Shenyang Military Region808 enrolled

Overview

Acute ischemic stroke (AIS) is the most common type of stroke, which has high rate of morbidity, mortality and disability. A large number of studies have confirmed that the thrombolytic therapy can effectively open blood vessels and improve the functional prognosis of acute ischemic stroke. Therefore, all guidelines recommend intravenous thrombolysis as the first treatment of ischemic stroke patients within 4.5 hours of onset. However, about 1/3 patients receiving thrombolysis will have good prognosis, while a large number of patients will still be disabled and even dead. How to improve the neurological prognosis of thrombolytic patients has been a hot topic in the world. Recent studies have found that the combined application of argatroban and rt-PA in the treatment of AIS might improve the clinical prognosis and not significantly increase bleeding. Some studies have reported that the combined application of argatroban and rt-PA could improve the blood vessel opening rate, and prevent re-occlusion after opening. Based on the discussion, the present study is designed to explore the efficacy and safety of argatroban plus rt-PA in the treatment of AIS.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

808

Conditions

Stroke

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. 18-80 years old; 2. Time from onset to treatment ≤4.5 hours; 3. NIHSS ≥ 6 4. Diagnosis of ischemic stroke 5. Signed informed consent by patient self or legally authorized representatives. Exclusion Criteria: 1. mRS≥2; 2. History of stroke within 3 months; 3. History of intracranial hemorrhage; 4. Suspected subarachnoid hemorrhage; 5. Intracranial tumour, vascular malformation or arterial aneurysm; 6. Major surgery within 1 month; 7. Systolic pressure ≥180 mmHg or diastolic pressure ≥110 mmHg; 8. Platelet count \< 105/mm3; 9. Heparin therapy or oral anticoagulation therapy within 48 hours; 10. Abnormal APTT; 11. Thrombin or Xa factor inhibitor; 12. Severe disease with a life expectancy of less than 3 months; 13. Blood glucose \< 50 mg/dL (2.7mmol/L); 14. Patients who have received any other investigational drug or device within 3 months; 15. Pregnancy; 16. Researchers consider patients inappropriate to participate in the registry.

Outcomes

Primary Outcomes

Proportion of mRS (0-1）

Time frame: 90±7 days

Secondary Outcomes

Proportion of mRS (0-2）

Time frame: 90±7 days

proportion of more than 2 decrease in NIHSS score

NIHSS, National Institute of Health stroke scale

Time frame: 48 hours

proportion of early neurological deterioration

Early neurological deterioration, defined as more than 4 increase in National Institute of Health stroke scale score

Time frame: 48 hours

Vascular Events

The occurence of stroke or other vascular events

Time frame: 90±7 days

symptomatic intracranial hemorrhage

Time frame: 48 hours

Argatroban Plus R-tPA for Acute Ischemic Stroke

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes