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Completed

NCT Number: NCT03552354

Argatroban Combined With Antiplatelet Versus Antiplatelet for Acute Ischemic Stroke

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.

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Key information

Conditions

Stroke, Ischemic Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

General Hospital of Shenyang Military Region

Shenyang, Liaoning, 10016, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Argatroban plus dual antiplatelet

Drug

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 outcomes

  1. Proportion of 1 or more increase in NIHSS

    Time frame: 7 days

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

Other outcomes

  1. Proportion of mRS 0-1

    Time frame: 90±7 days

    the excellent outcome is defined as modifed Rankin Score (mRS) 0-1 at 90 day

  2. Proportion of mRS 0-2

    Time frame: 90±7 days

    the good outcome is defined as modifed Rankin Score (mRS) 0-2 at 90 day

  3. proportion of intracranial haemorrhages

    Time frame: 90±7 days

    intracranial hemorrhage was defined as acute extravasation of blood into the brain parenchyma or subarachnoid space with associated neurologic symptoms

  4. proportion of organs hemorrhage

    Time frame: 90±7 days

    including gastrointestinal bleeding and mucocutaneous hemorrhage

  5. death

    Time frame: 90±7 days

    death due to any cause

Sponsors and collaborators

Lead sponsor

General Hospital of Shenyang Military Region

Other

Registry information

Official study title

Argatroban Combined With Antiplatelet Versus Antiplatelet for Acute Mild or Moderate Ischemic Stroke With Large-artery Atherosclerosis: a Prospective, Single Center Study

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Jun 11, 2018
Registry last updated
Jul 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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