Argatroban Combined With Antiplatelet Versus Antiplatelet for Acute Ischemic Stroke

NCT03552354 | Completed Phase 4

• 1 other identifier: k(2017)38
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Proportion of 1 or more increase in NIHSS

  early neurological deterioration is defined as 1 or more increase in NIHSS

  7 days

Other Outcomes (5)

• Proportion of mRS 0-1

  90±7 days

• Proportion of mRS 0-2

  90±7 days

• proportion of intracranial haemorrhages

  90±7 days

Study Arms (1)

Argatroban combined with antiplatelet

EXPERIMENTAL

Drug: Argatroban plus dual antiplatelet

Interventions

Argatroban plus dual antiplatelet DRUG

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

Argatroban combined with antiplatelet

Eligibility Criteria

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

You may qualify if:

• Age 18-80 years old;
• Clear diagnosis of ischemic stroke patients with head CT or MRI examination;
• The time of onset is less than 72 hours;
• NIHSS score is less than 12 points;
• the large artery atherosclerosis etiology
• Signed informed consent.

You may not qualify if:

• Hemorrhagic stroke or mixed stroke;
• Patients with planned thrombolytic therapy;
• Serious diseases such as severe infection or liver, kidney, hematopoietic system, endocrine system, etc.;
• The history of stroke and had serious sequelae (mRS\> 1);
• Allergic to aspirin/clopidogrel and argatroban;
• ischemic stroke caused by other causes, such as small vessel lesions, cardiogenic embolism, arterial dissection, vasculitis and other cerebral infarction;
• Previous history of cerebral hemorrhage;
• It is expected to use other anti-platelet agents or non-steroidal anti-inflammatory agents that affect platelet function;
• within 3 months of gastrointestinal bleeding or major surgery;
• any unqualified patients judged by researchers.

Sponsors & Collaborators

• General Hospital of Shenyang Military Region: lead

Study Sites (1)

General Hospital of Shenyang Military Region

Shenyang, Liaoning, 10016, China

Location

MeSH Terms

Conditions

Ischemic Stroke

Interventions

argatroban

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Department

Study Record Dates

• First Submitted: April 27, 2018
• First Posted: June 11, 2018
• Study Start: October 25, 2017
• Primary Completion: October 8, 2018
• Study Completion: January 8, 2019
• Last Updated: July 22, 2020

Record last verified: 2020-07

Locations

CN (1)