Argatroban Plus R-tPA for Acute Ischemic Stroke

Phase 4

Completed

• Conditions: Stroke
• Interventions: Drug: rt-PA; Drug: Argatroban

• Registration Number: NCT03740958
• Lead Sponsor: General Hospital of Shenyang Military Region

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-11-12
• Study First Submitted QC: 2018-11-12
• Study First Posted: 2018-11-14
• Study Start: 2018-12-21
• Primary Completion: 2022-01-30
• Study Completion: 2022-01-30
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-20
• Last Update Posted: 2022-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 808

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Argatroban combined with rt-PA	Argatroban	Drug: Argatroban combined with rt-PA Argatroban as a 100 ug/kg bolus over 3 to 5 minutes was administered intravenously within 1 hour of the tPA bolus followed by a continuous Argatroban infusion of 1.0 ug/kg per minute for 48 hours adjusted to a target activated partial thromboplastin time of 1.75 X baseline (about 10%)
Argatroban combined with rt-PA	rt-PA	Drug: Argatroban combined with rt-PA Argatroban as a 100 ug/kg bolus over 3 to 5 minutes was administered intravenously within 1 hour of the tPA bolus followed by a continuous Argatroban infusion of 1.0 ug/kg per minute for 48 hours adjusted to a target activated partial thromboplastin time of 1.75 X baseline (about 10%)
rt-PA	rt-PA	Drug: rt-PA Intravenous throbolysis with 0.9mg/kg rtPA.

Primary Outcome Measures

Name	Time	Method
Proportion of mRS (0-1）	90±7 days

Secondary Outcome Measures

Name	Time	Method
Proportion of mRS (0-2）	90±7 days
proportion of more than 2 decrease in NIHSS score	48 hours	NIHSS, National Institute of Health stroke scale
proportion of early neurological deterioration	48 hours	Early neurological deterioration, defined as more than 4 increase in National Institute of Health stroke scale score
Vascular Events	90±7 days	The occurence of stroke or other vascular events
symptomatic intracranial hemorrhage	48 hours

Trial Locations

Locations (1)

General Hospital of ShenYang Military Region; 🇨🇳 ShenYang, China