NCT03552354

Argatroban Combined With Antiplatelet Versus Antiplatelet for Acute Ischemic Stroke

Argatroban Combined With Antiplatelet Versus Antiplatelet for Acute Mild or Moderate Ischemic Stroke With Large-artery Atherosclerosis: a Prospective, Single Center Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: General Hospital of Shenyang Military Region · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Intravenous thrombolysis is considered as the first choice for ischemic stroke. In the recent years, endovascular therapy is demonstrated to be effective to treat ischemic with big vessel occlusion. However, only a minority of patients can get intravenous thrombolysis or endovascular therapy due to the restricted time window and strict indications. Dual antiplatelet has been demonstrated to be effective in the patients with high risk of TIA or minor ischemic stroke (NIHSS\<4). But there is still stroke progression although dual antiplatelet. The ischemic stroke patients with NIHSS \> 3 has been recommended to give aspirin in most guidelines. Of those patients, mild to moderate stroke patients (3\<NIHSS\<10) will result in the poor outcomes if the progression occurs. In addition, large artery atherosclerosis (LAA) stroke is prone to progress. So, we argue that the mild to moderate stroke with LAA should be give more intensive antiplatelet. In the present study, argatroban combined with antiplatelet therapy (3-5 days) is used to treat the proposed patients to investigate the safety and effectiveness.

Conditions

• Stroke, Ischemic

Interventions

Type	Name	Description
DRUG	Argatroban plus dual antiplatelet	A continuous argatroban infusion of 1.0 ug/kg per minute for 2-5 days adjusted to a target activated partial thromboplastin time of 1.75 X baseline (about 10%). For the first day, clopidogrel with loading dose 300mg, and aspirin 100mg were given, and followed by clopidogrel 75 mg and aspirin 100mg each day

Timeline

• Start date: 2017-10-25
• Primary completion: 2018-10-08
• Completion: 2019-01-08
• First posted: 2018-06-11
• Last updated: 2020-07-22

Locations

1 site across 1 country: China