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Argatroban Combined With Antiplatelet Versus Antiplatelet for Acute Ischemic Stroke

Primary Purpose

Stroke, Ischemic

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Argatroban plus dual antiplatelet
Sponsored by
General Hospital of Shenyang Military Region
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke, Ischemic

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • General Hospital of Shenyang Military Region

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Argatroban combined with antiplatelet

Arm Description

Outcomes

Primary Outcome Measures

Proportion of 1 or more increase in NIHSS
early neurological deterioration is defined as 1 or more increase in NIHSS

Secondary Outcome Measures

Full Information

First Posted
April 27, 2018
Last Updated
July 20, 2020
Sponsor
General Hospital of Shenyang Military Region
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1. Study Identification

Unique Protocol Identification Number
NCT03552354
Brief Title
Argatroban Combined With Antiplatelet Versus Antiplatelet for Acute Ischemic Stroke
Official Title
Argatroban Combined With Antiplatelet Versus Antiplatelet for Acute Mild or Moderate Ischemic Stroke With Large-artery Atherosclerosis: a Prospective, Single Center Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
October 25, 2017 (Actual)
Primary Completion Date
October 8, 2018 (Actual)
Study Completion Date
January 8, 2019 (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
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Ischemic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Argatroban combined with antiplatelet
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Argatroban plus dual antiplatelet
Intervention Description
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 Measure Information:
Title
Proportion of 1 or more increase in NIHSS
Description
early neurological deterioration is defined as 1 or more increase in NIHSS
Time Frame
7 days
Other Pre-specified Outcome Measures:
Title
Proportion of mRS 0-1
Description
the excellent outcome is defined as modifed Rankin Score (mRS) 0-1 at 90 day
Time Frame
90±7 days
Title
Proportion of mRS 0-2
Description
the good outcome is defined as modifed Rankin Score (mRS) 0-2 at 90 day
Time Frame
90±7 days
Title
proportion of intracranial haemorrhages
Description
intracranial hemorrhage was defined as acute extravasation of blood into the brain parenchyma or subarachnoid space with associated neurologic symptoms
Time Frame
90±7 days
Title
proportion of organs hemorrhage
Description
including gastrointestinal bleeding and mucocutaneous hemorrhage
Time Frame
90±7 days
Title
death
Description
death due to any cause
Time Frame
90±7 days

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: Age 18-80 years old; Clear diagnosis of ischemic stroke patients with head CT or MRI examination; The time of onset is less than 72 hours; NIHSS score is less than 12 points; the large artery atherosclerosis etiology Signed informed consent. Exclusion Criteria: Hemorrhagic stroke or mixed stroke; Patients with planned thrombolytic therapy; Serious diseases such as severe infection or liver, kidney, hematopoietic system, endocrine system, etc.; The history of stroke and had serious sequelae (mRS> 1); Allergic to aspirin/clopidogrel and argatroban; ischemic stroke caused by other causes, such as small vessel lesions, cardiogenic embolism, arterial dissection, vasculitis and other cerebral infarction; Previous history of cerebral hemorrhage; It is expected to use other anti-platelet agents or non-steroidal anti-inflammatory agents that affect platelet function; within 3 months of gastrointestinal bleeding or major surgery; any unqualified patients judged by researchers.
Facility Information:
Facility Name
General Hospital of Shenyang Military Region
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
10016
Country
China

12. IPD Sharing Statement

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Argatroban Combined With Antiplatelet Versus Antiplatelet for Acute Ischemic Stroke

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