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Argatroban Combined With Antiplatelet Versus Antiplatelet for Acute Ischemic Stroke

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03552354
Recruitment Status : Completed
First Posted : June 11, 2018
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Hui-Sheng Chen, General Hospital of Shenyang Military Region

Brief Summary:
Intravenous thrombolysis is considered as the first choice for ischemic stroke. In the recent years, endovascular therapy is demonstrated to be effective to treat ischemic with big vessel occlusion. However, only a minority of patients can get intravenous thrombolysis or endovascular therapy due to the restricted time window and strict indications. Dual antiplatelet has been demonstrated to be effective in the patients with high risk of TIA or minor ischemic stroke (NIHSS<4). But there is still stroke progression although dual antiplatelet. The ischemic stroke patients with NIHSS > 3 has been recommended to give aspirin in most guidelines. Of those patients, mild to moderate stroke patients (3<NIHSS<10) will result in the poor outcomes if the progression occurs. In addition, large artery atherosclerosis (LAA) stroke is prone to progress. So, we argue that the mild to moderate stroke with LAA should be give more intensive antiplatelet. In the present study, argatroban combined with antiplatelet therapy (3-5 days) is used to treat the proposed patients to investigate the safety and effectiveness.

Condition or disease Intervention/treatment Phase
Stroke, Ischemic Drug: Argatroban plus dual antiplatelet Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Argatroban Combined With Antiplatelet Versus Antiplatelet for Acute Mild or Moderate Ischemic Stroke With Large-artery Atherosclerosis: a Prospective, Single Center Study
Actual Study Start Date : October 25, 2017
Actual Primary Completion Date : October 8, 2018
Actual Study Completion Date : January 8, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Argatroban

Arm Intervention/treatment
Experimental: Argatroban combined with antiplatelet Drug: Argatroban plus dual antiplatelet
A continuous argatroban infusion of 1.0 ug/kg per minute for 2-5 days adjusted to a target activated partial thromboplastin time of 1.75 X baseline (about 10%). For the first day, clopidogrel with loading dose 300mg, and aspirin 100mg were given, and followed by clopidogrel 75 mg and aspirin 100mg each day




Primary Outcome Measures :
  1. Proportion of 1 or more increase in NIHSS [ Time Frame: 7 days ]

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

Other Outcome Measures:
  1. proportion of intracranial haemorrhages [ Time Frame: 7 days ]


Information from the National Library of Medicine

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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. Age 18-80 years old;
  2. Clear diagnosis of ischemic stroke patients with head CT or MRI examination;
  3. The time of onset is less than 72 hours;
  4. NIHSS score is less than 12 points;
  5. the large artery atherosclerosis etiology
  6. Signed informed consent.

Exclusion Criteria:

  1. Hemorrhagic stroke or mixed stroke;
  2. Patients with planned thrombolytic therapy;
  3. Serious diseases such as severe infection or liver, kidney, hematopoietic system, endocrine system, etc.;
  4. The history of stroke and had serious sequelae (mRS> 1);
  5. Allergic to aspirin/clopidogrel and argatroban;
  6. ischemic stroke caused by other causes, such as small vessel lesions, cardiogenic embolism, arterial dissection, vasculitis and other cerebral infarction;
  7. Previous history of cerebral hemorrhage;
  8. It is expected to use other anti-platelet agents or non-steroidal anti-inflammatory agents that affect platelet function;
  9. within 3 months of gastrointestinal bleeding or major surgery;
  10. any unqualified patients judged by researchers.

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): NCT03552354


Locations
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China, Liaoning
General Hospital of Shenyang Military Region
Shenyang, Liaoning, China, 10016
Sponsors and Collaborators
General Hospital of Shenyang Military Region

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Responsible Party: Hui-Sheng Chen, Director of the Department, General Hospital of Shenyang Military Region
ClinicalTrials.gov Identifier: NCT03552354    
Other Study ID Numbers: k(2017)38
First Posted: June 11, 2018    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019

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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
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Argatroban
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants
Platelet Aggregation Inhibitors