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Argatroban Plus R-tPA for Acute Ischemic Stroke

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ClinicalTrials.gov Identifier: NCT03740958
Recruitment Status : Recruiting
First Posted : November 14, 2018
Last Update Posted : December 25, 2018
Sponsor:
Information provided by (Responsible Party):
Hui-Sheng Chen, 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.


Condition or disease Intervention/treatment Phase
Stroke Drug: rt-PA Drug: Argatroban Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 808 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Argatroban Plus R-tPA for Acute Ischemic Stroke: a Prospective, Random, Open Label, Blinded Assessment of Outcome Multi-center Study
Actual Study Start Date : December 21, 2018
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Argatroban combined with 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%)
Drug: rt-PA
Intravenous throbolysis with 0.9mg/kg rtPA

Drug: Argatroban
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%)

Active Comparator: rt-PA
Drug: rt-PA Intravenous throbolysis with 0.9mg/kg rtPA.
Drug: rt-PA
Intravenous throbolysis with 0.9mg/kg rtPA




Primary Outcome Measures :
  1. Proportion of mRS (0-1) [ Time Frame: 90±7 days ]

Secondary Outcome Measures :
  1. Proportion of mRS (0-2) [ Time Frame: 90±7 days ]
  2. proportion of more than 2 decrease in NIHSS score [ Time Frame: 48 hours ]
    NIHSS, National Institute of Health stroke scale

  3. proportion of early neurological deterioration [ Time Frame: 48 hours ]
    Early neurological deterioration, defined as more than 4 increase in National Institute of Health stroke scale score

  4. Vascular Events [ Time Frame: 90±7 days ]
    The occurence of stroke or other vascular events

  5. symptomatic intracranial hemorrhage [ Time Frame: 48 hours ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03740958


Contacts
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Contact: Xinhong Wang, Doctor 15309885658 ext 024-28897512 450341972@qq.com
Contact: Yu Cui, Master 18842398646 ext 024-28897512 314486939@qq.com

Locations
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China
General Hospital of ShenYang Military Region Recruiting
ShenYang, China
Contact: Zhong-He Zhou, Ph.D       zhouz.h@tom.com   
Sponsors and Collaborators
General Hospital of Shenyang Military Region
Investigators
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Study Chair: Huisheng Chen, Doctor Neurology Department

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Responsible Party: Hui-Sheng Chen, Department Chairman, General Hospital of Shenyang Military Region
ClinicalTrials.gov Identifier: NCT03740958     History of Changes
Other Study ID Numbers: k (2018)45
First Posted: November 14, 2018    Key Record Dates
Last Update Posted: December 25, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Tissue Plasminogen Activator
Argatroban
Thromboplastin
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Anticoagulants
Platelet Aggregation Inhibitors
Hemostatics
Coagulants