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

Argatroban, Rt-PA Clinical Trial

Official title:

Argatroban Plus R-tPA for Acute Posterior Circulation Infarction (AR-PCI): a Prospective, Random, Blinded Assessment of Outcome and Open Label Multi-center Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03506009
• Other study ID #: k(2017)29
• Status: Terminated
• Phase: Phase 4
• Start date: July 11, 2018
• Est. completion date: November 13, 2018

Study information

• Verified date: November 2018
• Source: General Hospital of Shenyang Military Region
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: November 13, 2018
• Est. primary completion date: November 13, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Argatroban, Rt-PA
• Infarction

Intervention

Drug:
• 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%).
• rt-PA
Intravenous throbolysis with 0.9mg/kg rtPA.

Locations

Country	Name	City	State
China	General Hospital of Shenyang Military Region	Shenyang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
Hui-Sheng Chen

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of mRS (0-1)		90±7 days
Secondary	Early neurological deterioration	4 or more increase in NIHSS	48 hours
Secondary	Proportion of mRS (0-2)		90±7 days
Secondary	the occurence of stroke		90±7 days
Secondary	symptomatic intracranial hemorrhage		36 hours