Argatroban Plus r-tPA for Posterior Circulation Infarction(AR-PCI)

H

Hui-Sheng Chen

Status and phase

Terminated
Phase 4

Conditions

Argatroban, Rt-PA

Treatments

Drug: rt-PA
Drug: Argatroban combined with rt-PA

Study type

Interventional

Funder types

Other

Identifiers

NCT03506009
k(2017)29

Details and patient eligibility

About

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 giving thrombolysis treatment to acute 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 neurofunction 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 acute anterior circulation infarction 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 acute posterior circulation infarction.

Enrollment

3 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. 18-80 years old;
  2. Diagnosis of posterior circulation ischemic stroke;
  3. Time from onset to treatment ≤6 hours;
  4. NIHSS: 4-25;
  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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

3 participants in 2 patient groups

Argatroban combined with rt-PA
Experimental group
Treatment:
Drug: Argatroban combined with rt-PA
rt-PA
Active Comparator group
Treatment:
Drug: rt-PA

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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