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

NCT03506009 | Terminated Phase 4 DMC

• 1 other identifier: k(2017)29
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Proportion of mRS (0-1）

  90±7 days

Secondary Outcomes (4)

• 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

Study Arms (2)

Argatroban combined with rt-PA

EXPERIMENTAL

Drug: Argatroban combined with rt-PA

rt-PA

ACTIVE COMPARATOR

Drug: rt-PA

Interventions

Argatroban combined with rt-PA 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%).

Argatroban combined with rt-PA

rt-PA DRUG

Intravenous throbolysis with 0.9mg/kg rtPA.

rt-PA

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• mRS≥2;
• 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;
• Severe disease with a life expectancy of less than 3 months;
• Blood glucose \< 50 mg/dL (2.7mmol/L);
• Patients who have received any other investigational drug or device within 3 months;
• Pregnancy;

Sponsors & Collaborators

• Hui-Sheng Chen: lead

Study Sites (1)

General Hospital of Shenyang Military Region

Shenyang, Liaoning, 10016, China

Location

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 15, 2018
• First Posted: April 23, 2018
• Study Start: July 11, 2018
• Primary Completion: November 13, 2018
• Study Completion: November 13, 2018
• Last Updated: November 14, 2018

Record last verified: 2018-11

Locations

CN (1)