Argatroban Plus R-tPA for Acute Ischemic Stroke
Primary Purpose
Stroke
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
rt-PA
Argatroban
Sponsored by
About this trial
This is an interventional treatment trial for Stroke
Eligibility Criteria
Inclusion Criteria:
- 18-80 years old;
- Time from onset to treatment ≤4.5 hours;
- NIHSS ≥ 6
- Diagnosis of ischemic stroke
- Signed informed consent by patient self or legally authorized representatives.
Exclusion Criteria:
- mRS≥2;
- History of stroke within 3 months;
- History of intracranial hemorrhage;
- Suspected subarachnoid hemorrhage;
- Intracranial tumour, vascular malformation or arterial aneurysm;
- Major surgery within 1 month;
- Systolic pressure ≥180 mmHg or diastolic pressure ≥110 mmHg;
- Platelet count < 105/mm3;
- Heparin therapy or oral anticoagulation therapy within 48 hours;
- Abnormal APTT;
- Thrombin or Xa factor inhibitor;
- Severe disease with a life expectancy of less than 3 months;
- Blood glucose < 50 mg/dL (2.7mmol/L);
- Patients who have received any other investigational drug or device within 3 months;
- Pregnancy;
- Researchers consider patients inappropriate to participate in the registry.
Sites / Locations
- General Hospital of ShenYang Military Region
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Argatroban combined with rt-PA
rt-PA
Arm Description
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%)
Drug: rt-PA Intravenous throbolysis with 0.9mg/kg rtPA.
Outcomes
Primary Outcome Measures
Proportion of mRS (0-1)
Secondary Outcome Measures
Proportion of mRS (0-2)
proportion of more than 2 decrease in NIHSS score
NIHSS, National Institute of Health stroke scale
proportion of early neurological deterioration
Early neurological deterioration, defined as more than 4 increase in National Institute of Health stroke scale score
Vascular Events
The occurence of stroke or other vascular events
symptomatic intracranial hemorrhage
Full Information
NCT ID
NCT03740958
First Posted
November 12, 2018
Last Updated
February 20, 2022
Sponsor
General Hospital of Shenyang Military Region
1. Study Identification
Unique Protocol Identification Number
NCT03740958
Brief Title
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
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
December 21, 2018 (Actual)
Primary Completion Date
January 30, 2022 (Actual)
Study Completion Date
January 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
General Hospital of Shenyang Military Region
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
808 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Argatroban combined with rt-PA
Arm Type
Experimental
Arm Description
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%)
Arm Title
rt-PA
Arm Type
Active Comparator
Arm Description
Drug: rt-PA Intravenous throbolysis with 0.9mg/kg rtPA.
Intervention Type
Drug
Intervention Name(s)
rt-PA
Intervention Description
Intravenous throbolysis with 0.9mg/kg rtPA
Intervention Type
Drug
Intervention Name(s)
Argatroban
Intervention Description
100 ug/kg bolus over 3 to 5 minutes was administered intravenously, 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%)
Primary Outcome Measure Information:
Title
Proportion of mRS (0-1)
Time Frame
90±7 days
Secondary Outcome Measure Information:
Title
Proportion of mRS (0-2)
Time Frame
90±7 days
Title
proportion of more than 2 decrease in NIHSS score
Description
NIHSS, National Institute of Health stroke scale
Time Frame
48 hours
Title
proportion of early neurological deterioration
Description
Early neurological deterioration, defined as more than 4 increase in National Institute of Health stroke scale score
Time Frame
48 hours
Title
Vascular Events
Description
The occurence of stroke or other vascular events
Time Frame
90±7 days
Title
symptomatic intracranial hemorrhage
Time Frame
48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18-80 years old;
Time from onset to treatment ≤4.5 hours;
NIHSS ≥ 6
Diagnosis of ischemic stroke
Signed informed consent by patient self or legally authorized representatives.
Exclusion Criteria:
mRS≥2;
History of stroke within 3 months;
History of intracranial hemorrhage;
Suspected subarachnoid hemorrhage;
Intracranial tumour, vascular malformation or arterial aneurysm;
Major surgery within 1 month;
Systolic pressure ≥180 mmHg or diastolic pressure ≥110 mmHg;
Platelet count < 105/mm3;
Heparin therapy or oral anticoagulation therapy within 48 hours;
Abnormal APTT;
Thrombin or Xa factor inhibitor;
Severe disease with a life expectancy of less than 3 months;
Blood glucose < 50 mg/dL (2.7mmol/L);
Patients who have received any other investigational drug or device within 3 months;
Pregnancy;
Researchers consider patients inappropriate to participate in the registry.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huisheng Chen, Doctor
Organizational Affiliation
Neurology Department
Official's Role
Study Chair
Facility Information:
Facility Name
General Hospital of ShenYang Military Region
City
ShenYang
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
32485328
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.
Results Reference
derived
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Argatroban Plus R-tPA for Acute Ischemic Stroke
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