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An efficacy study of argatroban and combination antiplatelet in patients with acute ischemic cerebrovascular disease

An efficacy study of argatroban and combination antiplatelet in patients with acute ischemic cerebrovascular disease

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-13003384
Enrollment
Unknown
Registered
2013-07-02
Start date
2013-07-31
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute ischemic cerebrovascular disease

Interventions

argatroban:argatroban
antiplatelet therapy:antiplatelet therapy

Sponsors

Department of neurology of Hospital of Shenyang military area command of Chinese PLA
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. The patients with clear consciousness should sign informed consent,or the legal representative of the patients should sign informed consent; 2. The patients should be diagnosed as acute ischemic stroke within 48 hours of onset.Diagnostic criteria should meet the diagnosis standard revised in the Fourth National Academic Conference on cerebrovascular disease; 3. The age of the patients regardless of gender should be between 18-80; 4. Neurological deficits include NIHSS scores of 3-15 for anterior circulation cerebral infarction,and non-coma for posterior circulation cerebral infarction, and ABCD2 scores above 3 for TIA; 5. The blood pressure should be less than 180/110mmHg; 6. There is no bleeding in brain CT;7.The patients should have the first stroke attack, or the patients should have the second stroke attack with no sequel of the first stroke attack, or the patients should have the second stroke attack with clear NIHSS scores.

Exclusion criteria

Exclusion criteria: 1.Patients with serious heart diseases,liver diseases(glutamic pyruciv transaminase or aspartate aminotransferase is higher than the normal value of 1~1.5 times),kidney diseases(urea or creatinine is greater than the normal range above 10%), hematologic diseases and bleeding tendency should be excluded; 2.Uncontrolled hypertension(blood pressure>180/110mmHg)should be excluded; 3.Laboratory examination revealing dysfunction of blood coagulation should be excluded; 4.Hemorrhagic stroke, essential thrombopenia, bleeding tendency caused by abnormal vascular function,hemophilia,other coagulation disorders, menstrual period, operation period, hemorrhage of digestive tract, hemorrhage of urinary tract, hemoptysis, and genital bleeding after childbirth or abortion should be excluded; 5.Massive cerebral infarction or cerebral hernia should be excluded; 6.Stroke with severe disorders of consciousness(NIHSS scores=20), mental disease, dementia, and other uncooperative patients should be excluded; 7.Patients with aneurysm,vascular malformation, cerebral cysticercosis, intracerebral schistosomiasis, encephalitis,meningitis,hydrocephalus or post-traumatic brain syndrome should be excluded; 8. Patients with milignant tumor,intracranial tumor, hematologic disease or HIV should be excluded; 9.Patients suffering from operation or trauma within 3 months should be excluded; 10.Patients having a history of allergy to this class of drugs should be excluded; 11.Pregnant women, pregnancy planners in 5 drug half-life after this study, or breastfeeding should be excluded; 12.Patients treated with vasodilators, other durgs with this study does not specify, anticoagulants or fibrinolytic drugs should be excluded; 13.Patients treated with heparin or low molecular weight heparin should be excluded. Heparin induced thrombocytopenia patients should be excluded; 14.Patients treated with antiplatelet drugs, whose effective concentration in vivo is not eliminated, should be excluded; 15.Patients who participated in other clinical trials within 3 months should be excluded; 16.Patients with dysphagia should be excluded.

Design outcomes

Primary

MeasureTime frame
NIHSS score;

Secondary

MeasureTime frame
muscle force;

Countries

China

Contacts

Public ContactChen Huisheng
chszh@aliyun.com+86 13352452086

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026