Argatroban Plus R-tPA for Acute Posterior Circulation Infarction (AR-PCI): a Prospective, Random, Blinded Assessment of Outcome and Open Label Multi-center Study
Overview
- Phase
- Phase 4
- Intervention
- Argatroban combined with rt-PA
- Conditions
- Argatroban, Rt-PA
- Sponsor
- Hui-Sheng Chen
- Enrollment
- 3
- Locations
- 1
- Primary Endpoint
- Proportion of mRS (0-1）
- Status
- Terminated
- Last Updated
- 7 years ago
Overview
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.
Investigators
Hui-Sheng Chen
Professor
General Hospital of Shenyang Military Region
Eligibility Criteria
Inclusion Criteria
- •18-80 years old;
- •Diagnosis of posterior circulation ischemic stroke;
- •Time from onset to treatment ≤6 hours;
- •NIHSS: 4-25;
- •Signed informed consent by patient self or legally authorized representatives.
Exclusion Criteria
- •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;
Arms & Interventions
Argatroban combined with rt-PA
Intervention: Argatroban combined with rt-PA
rt-PA
Intervention: rt-PA
Outcomes
Primary Outcomes
Proportion of mRS (0-1）
Time Frame: 90±7 days
Secondary Outcomes
- Early neurological deterioration(48 hours)
- Proportion of mRS (0-2）(90±7 days)
- the occurence of stroke(90±7 days)
- symptomatic intracranial hemorrhage(36 hours)