Clinical trial NCT03740958: Argatroban Plus R-tPA for Acute Ischemic Stroke
Official title: Argatroban Plus R-tPA for Acute Ischemic Stroke: a Prospective, Random, Open Label, Blinded Assessment of Outcome Multi-center Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Stroke
Lead sponsor: General Hospital of Shenyang Military Region
Sponsor class: OTHER
First posted: 2018-11-14
Enrollment: 808
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of mRS (0-1）
timeFrame: 90±7 days
Secondary outcomes:
measure: Proportion of mRS (0-2）
timeFrame: 90±7 days
measure: proportion of more than 2 decrease in NIHSS score
timeFrame: 48 hours
measure: proportion of early neurological deterioration
timeFrame: 48 hours
measure: Vascular Events
timeFrame: 90±7 days
measure: symptomatic intracranial hemorrhage
timeFrame: 48 hours
Other outcomes:
Locations:
city: ShenYang
country: China
facility: General Hospital of ShenYang Military Region
Study officials:
affiliation: Neurology Department
name: Huisheng Chen, Doctor
role: STUDY_CHAIR
References:
citation: Yang Y, Zhou Z, Pan Y, Chen H, Wang Y; ARAIS Protocol Steering Group. Randomized trial of argatroban plus recombinant tissue-type plasminogen activator for acute ischemic stroke (ARAIS): Rationale and design. Am Heart J. 2020 Jul;225:38-43. doi: 10.1016/j.ahj.2020.04.003. Epub 2020 Apr 8.