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Completed

NCT Number: NCT03740958

Argatroban Plus R-tPA for Acute Ischemic Stroke

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.

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Key information

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, China

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

rt-PA

Drug

Intravenous throbolysis with 0.9mg/kg rtPA

Argatroban

Drug

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 outcomes

  1. Proportion of mRS (0-1)

    Time frame: 90±7 days

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

General Hospital of Shenyang Military Region

Other

Registry information

Official study title

Argatroban Plus R-tPA for Acute Ischemic Stroke: a Prospective, Random, Open Label, Blinded Assessment of Outcome Multi-center Study

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Nov 14, 2018
Registry last updated
Feb 22, 2022

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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