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

Sponsor

Hui-Sheng Chen (Other)

Overall Status

Terminated

CT.gov ID

NCT03506009

Collaborator

(none)

Enrollment

Location

Arms

4.1

Actual Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Argatroban, Rt-PA	Drug: Argatroban combined with rt-PA Drug: rt-PA	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

3 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jul 11, 2018

Actual Primary Completion Date :

Nov 13, 2018

Actual Study Completion Date :

Nov 13, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Argatroban combined with rt-PA	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%).
Active Comparator: rt-PA	Drug: rt-PA Intravenous throbolysis with 0.9mg/kg rtPA.

Arm

Intervention/Treatment

Experimental: Argatroban combined with rt-PA

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%).

Active Comparator: rt-PA

Drug: rt-PA

Intravenous throbolysis with 0.9mg/kg rtPA.

Outcome Measures

Primary Outcome Measures

Proportion of mRS (0-1） [90±7 days]

Secondary Outcome Measures

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]
symptomatic intracranial hemorrhage [36 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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:

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;
Researchers consider patients inappropriate to participate in the registry.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	General Hospital of Shenyang Military Region	Shenyang	Liaoning	China	10016

Sponsors and Collaborators

Hui-Sheng Chen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hui-Sheng Chen, Professor, General Hospital of Shenyang Military Region

ClinicalTrials.gov Identifier:

NCT03506009

Other Study ID Numbers:

k(2017)29

First Posted:

Apr 23, 2018

Last Update Posted:

Nov 14, 2018

Last Verified:

Nov 1, 2018

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Infarction

Tissue Plasminogen Activator

Argatroban

Study Results

No Results Posted as of Nov 14, 2018