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

Phase 4

Terminated

• Conditions: Argatroban, Rt-PA
• Interventions: Drug: Argatroban combined with rt-PA; Drug: rt-PA

• Registration Number: NCT03506009
• Lead Sponsor: Hui-Sheng Chen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-04-15
• Study First Submitted QC: 2018-04-15
• Study First Posted: 2018-04-23
• Study Start: 2018-07-11
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-12
• Primary Completion: 2018-11-13
• Study Completion: 2018-11-13
• Last Update Posted: 2018-11-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Argatroban combined with rt-PA	Argatroban combined with rt-PA	-
rt-PA	rt-PA	-

Primary Outcome Measures

Name	Time	Method
Proportion of mRS (0-1）	90±7 days

Secondary Outcome Measures

Name	Time	Method
symptomatic intracranial hemorrhage	36 hours
Early neurological deterioration	48 hours	4 or more increase in NIHSS
Proportion of mRS (0-2）	90±7 days
the occurence of stroke	90±7 days

Trial Locations

Locations (1)

General Hospital of Shenyang Military Region; 🇨🇳 Shenyang, Liaoning, China