Argatroban Combined With Antiplatelet Versus Antiplatelet for Acute Ischemic Stroke

Stroke, Ischemic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03552354
• Other study ID #: k(2017)38
• Status: Completed
• Phase: Phase 4
• Start date: October 25, 2017
• Est. completion date: January 8, 2019

Study information

• Verified date: July 2020
• Source: General Hospital of Shenyang Military Region
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: January 8, 2019
• Est. primary completion date: October 8, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Age 18-80 years old;

2. Clear diagnosis of ischemic stroke patients with head CT or MRI examination;

3. The time of onset is less than 72 hours;

4. NIHSS score is less than 12 points;

5. the large artery atherosclerosis etiology

6. Signed informed consent.

Exclusion Criteria:

1. Hemorrhagic stroke or mixed stroke;

2. Patients with planned thrombolytic therapy;

3. Serious diseases such as severe infection or liver, kidney, hematopoietic system, endocrine system, etc.;

4. The history of stroke and had serious sequelae (mRS> 1);

5. Allergic to aspirin/clopidogrel and argatroban;

6. ischemic stroke caused by other causes, such as small vessel lesions, cardiogenic embolism, arterial dissection, vasculitis and other cerebral infarction;

7. Previous history of cerebral hemorrhage;

8. It is expected to use other anti-platelet agents or non-steroidal anti-inflammatory agents that affect platelet function;

9. within 3 months of gastrointestinal bleeding or major surgery;

10. any unqualified patients judged by researchers.

Related Conditions & MeSH terms

• Ischemia
• Stroke
• Stroke, Ischemic

Intervention

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

Locations

Country	Name	City	State
China	General Hospital of Shenyang Military Region	Shenyang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
General Hospital of Shenyang Military Region

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Proportion of mRS 0-1	the excellent outcome is defined as modifed Rankin Score (mRS) 0-1 at 90 day	90±7 days
Other	Proportion of mRS 0-2	the good outcome is defined as modifed Rankin Score (mRS) 0-2 at 90 day	90±7 days
Other	proportion of intracranial haemorrhages	intracranial hemorrhage was defined as acute extravasation of blood into the brain parenchyma or subarachnoid space with associated neurologic symptoms	90±7 days
Other	proportion of organs hemorrhage	including gastrointestinal bleeding and mucocutaneous hemorrhage	90±7 days
Other	death	death due to any cause	90±7 days
Primary	Proportion of 1 or more increase in NIHSS	early neurological deterioration is defined as 1 or more increase in NIHSS	7 days