Clinical trial NCT03552354: Argatroban Combined With Antiplatelet Versus Antiplatelet for Acute Ischemic Stroke
Official title: Argatroban Combined With Antiplatelet Versus Antiplatelet for Acute Mild or Moderate Ischemic Stroke With Large-artery Atherosclerosis: a Prospective, Single Center Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Stroke, Ischemic
Lead sponsor: General Hospital of Shenyang Military Region
Sponsor class: OTHER
First posted: 2018-06-11
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of 1 or more increase in NIHSS
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
measure: Proportion of mRS 0-1
timeFrame: 90±7 days
measure: Proportion of mRS 0-2
timeFrame: 90±7 days
measure: proportion of intracranial haemorrhages
timeFrame: 90±7 days
measure: proportion of organs hemorrhage
timeFrame: 90±7 days
measure: death
timeFrame: 90±7 days
Locations:
city: Shenyang
country: China
facility: General Hospital of Shenyang Military Region
state: Liaoning
Study officials:
References: