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

NCT ID: NCT03506009

Last Updated: 2018-11-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-11
• Study Completion Date: 2018-11-13

Brief Summary

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.

Conditions

Argatroban, Rt-PA

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Argatroban combined with rt-PA

Group Type: EXPERIMENTAL

Argatroban combined with rt-PA

Intervention Type: DRUG

Argatroban as a 100-ug/kg bolus over 3 to 5 minutes was administered intravenously within 1 hour of the tPA bolus 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%).

rt-PA

Group Type: ACTIVE_COMPARATOR

rt-PA

Intervention Type: DRUG

Intravenous throbolysis with 0.9mg/kg rtPA.

Interventions

Argatroban combined with rt-PA

Argatroban as a 100-ug/kg bolus over 3 to 5 minutes was administered intravenously within 1 hour of the tPA bolus 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%).

Intervention Type: DRUG

rt-PA

Intravenous throbolysis with 0.9mg/kg rtPA.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hui-Sheng Chen

OTHER

Sponsor Role: lead

Responsible Party

Hui-Sheng Chen

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

General Hospital of Shenyang Military Region

Shenyang, Liaoning, China

Countries

China

Other Identifiers

k(2017)29

Identifier Type: -

Identifier Source: org_study_id