Argatroban Plus R-tPA for Acute Ischemic Stroke

• Sponsor: General Hospital of Shenyang Military Region (Other)
• Overall Status: Completed
• CT.gov ID: NCT03740958
• Collaborator: (none)
• Enrollment: 808
• Location: 1
• Arms: 2
• Actual Duration (Months): 37.3
• Patients Per Site Per Month: 21.6

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 intravenous thrombolysis as the first treatment of 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 neurological 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 AIS 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 AIS.

Condition or Disease	Intervention/Treatment	Phase
Stroke	Drug: rt-PA; Drug: Argatroban	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 808 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Argatroban Plus R-tPA for Acute Ischemic Stroke: a Prospective, Random, Open Label, Blinded Assessment of Outcome Multi-center Study
• Actual Study Start Date: Dec 21, 2018
• Actual Primary Completion Date: Jan 30, 2022
• Actual Study Completion Date: Jan 30, 2022

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%)	Drug: rt-PA; Intravenous throbolysis with 0.9mg/kg rtPA; Drug: Argatroban; 100 ug/kg bolus over 3 to 5 minutes was administered intravenously, 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.	Drug: rt-PA; Intravenous throbolysis with 0.9mg/kg rtPA

Outcome Measures

Primary Outcome Measures

1. Proportion of mRS (0-1） [90±7 days]

Secondary Outcome Measures

1. Proportion of mRS (0-2） [90±7 days]

2. proportion of more than 2 decrease in NIHSS score [48 hours]

   NIHSS, National Institute of Health stroke scale

3. proportion of early neurological deterioration [48 hours]

   Early neurological deterioration, defined as more than 4 increase in National Institute of Health stroke scale score

4. Vascular Events [90±7 days]

   The occurence of stroke or other vascular events

5. symptomatic intracranial hemorrhage [48 hours]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. 18-80 years old;

2. Time from onset to treatment ≤4.5 hours;

3. NIHSS ≥ 6

4. Diagnosis of ischemic stroke

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	General Hospital of ShenYang Military Region	ShenYang		China

Sponsors and Collaborators

• General Hospital of Shenyang Military Region

Investigators

• Study Chair: Huisheng Chen, Doctor, Neurology Department

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hui-Sheng Chen, Department Chairman, General Hospital of Shenyang Military Region
• ClinicalTrials.gov Identifier: NCT03740958
• Other Study ID Numbers: k （2018）45
• First Posted: Nov 14, 2018
• Last Update Posted: Feb 22, 2022
• Last Verified: Feb 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Stroke; Ischemic Stroke; Argatroban

Study Results

No Results Posted as of Feb 22, 2022