Safety and Efficacy of Aspirin in Stroke Patients With Glucose-6-phosphate Dehydrogenase Deficiency (SAST)
NCT ID: NCT04088513
Last Updated: 2022-03-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
440 participants
INTERVENTIONAL
2020-01-22
2024-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Aspirin
Drugs:Aspirin
Aspirin
This group will receive a 100 mg/day aspirin plus clopidogrel placebo for 90 days.
Clopidogrel
Drugs:Clopidogrel
Clopidogrel
This group will receive a 75 mg/day clopidogrel plus aspirin placebo for 90 days.
Interventions
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Aspirin
This group will receive a 100 mg/day aspirin plus clopidogrel placebo for 90 days.
Clopidogrel
This group will receive a 75 mg/day clopidogrel plus aspirin placebo for 90 days.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Acute ischemic stroke within 14 days of symptoms onset;
3. Glucose-6-phosphate dehydrogenase deficiency screened in G6PD enzyme activity
4. Had not received aspirin 7 days prior to randomization
5. Informed consent signed
Exclusion Criteria
2. Concomitant infections at the time of randomization
3. mRS\>2 prior to the presenting stroke
4. Hemoglobin\<10 g/dL prior to randomization
5. Received intravenous thrombolytic therapy or neurointervention treatment before randomization
6. Clear indication for anticoagulation (presumed cardioembolism, eg, atrial fibrillation, prosthetic cardiac valves or suspected endocarditis)
7. Clear indication for dual antiplatelet therapy (eg, minor stroke in 24h (NIHSS ≤3) or endovascular therapy for the indexed event)
8. Anticipated concomitant antiplatelets other than aspirin or clopidogrel (eg, GPIIb/IIIa inhibitors, ticlopidine, prasugrel, dipyridamole, ozagrel, cilostazol, ticagrelor) and other antithrombotic agents with antiplatelet effects, including traditional/herbal medicine agents.
9. Anticipated concomitant therapy with long-term (\>7 days) NSAIDs affecting platelet function
10. Contraindication to clopidogrel or aspirin (1)Known allergic reactions (2)Severe hepatic or renal dysfunction (Severe hepatic dysfunction is defined as serum ALT or AST \>2 times the upper limit of the normal group；Severe renal dysfunction is defined as serum creatinine \> 1.5 times the upper limit of the normal group) (3)Severe cardiac failure（NYHA class Ⅲ or Ⅳ) (4)Asthma (5)Any history of Hemostatic disorder or systemic bleeding (6)Any history of thrombocytopenia or neutropenia (7)Any history of drug-induced hematologic or hepatic insufficiency (8)Low white blood cell (\<2×10\^9/L) or platelet count (\<100×10\^9/L)
11. Any history of thalassemia, autoimmune hemolytic disease, aplastic anemia or other severe hematologic diseases
12. Anticipated concomitant therapy with other contraindicated drugs for G6PD deficiency
13. Severe dysphagia to unable swallow the drugs
14. Concomitant infections and need for antimicrobial therapy
15. Intracranial hemorrhage or gastrointestinal bleed within 3 months, or major surgery within 30 days
16. Stomach tumor or any other malignant tumor
17. Planed surgery or interventional treatment that may affect the study procedure
18. Severe non-cardiovascular comorbidity with life expectancy \<3 m
19. Female who is pregnant or lactating
20. Currently receiving an investigational drug or device
21. Inability to understand and/or comply with study procedures due to psychosis, cognition impairment or emotion disturbance.
40 Years
ALL
No
Sponsors
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First Affiliated Hospital, Sun Yat-Sen University
OTHER
Responsible Party
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Jinsheng Zeng, MD, PhD
Professor
Principal Investigators
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Jinsheng Zeng, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
First Affiliated Hospital, Sun Yat-Sen University
Locations
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Longyan First Hospital
Longyan, Fujian, China
Sanming First Hospital
Sanming, Fujian, China
The First Affiliated Hospital of Guangdong Pharmaceutical University
Guangzhou, Guangdong, China
The First Affiliated Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, China
The First Affiliated Hospital of Jinan University
Guangzhou, Guangdong, China
Jieyang Municipal People's Hospital
Jieyang, Guangdong, China
Meizhou City People's Hospital
Meizhou, Guangdong, China
Yue Bei People's Hospital
Shaoguan, Guangdong, China
Yunfu People's Hospital
Yunfu, Guangdong, China
People's Hospital of Baise
Baise City, Guangxi, China
The Forth Affiliated Hospital of Guangxi Medical Hospital
Liuzhou, Guangxi, China
The First Affiliated Hospital of Guangxi Medical Hospital
Nanning, Guangxi, China
Beiliu People's Hospital
Yulin, Guangxi, China
The Second Affiliated Hospital of Hainan Medical University
Haikou, Hainan, China
Fengcheng People's Hospital
Fengcheng, Jiangxi, China
Ganzhou Municipal Hospital
Ganzhou, Jiangxi, China
First Affiliated Hospital of Gannan Medical University
Ganzhou, Jiangxi, China
Ganzhou People' Hospital
Ganzhou, Jiangxi, China
The Forth Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Countries
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Central Contacts
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Facility Contacts
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Yangui Chen
Role: primary
Weimin Hong
Role: primary
Jiakai Li
Role: primary
Dengrong Ban
Role: primary
Bin Chen
Role: primary
Hongxing Huang
Role: primary
Zheng Liu
Role: primary
Xianghong Liu
Role: primary
Other Identifiers
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2018001
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
SAST
Identifier Type: -
Identifier Source: org_study_id
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