Status:
UNKNOWN
Safety and Efficacy of Aspirin in Stroke Patients With Glucose-6-phosphate Dehydrogenase Deficiency (SAST)
Lead Sponsor:
First Affiliated Hospital, Sun Yat-Sen University
Conditions:
G6PD Deficiency
Stroke
Eligibility:
All Genders
40+ years
Phase:
PHASE4
Brief Summary
Aspirin was reported to induce hemolysis in patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency on some occasions, while still widely uesd for stroke prevention. The SAST trial is design...
Detailed Description
This SAST trial is a prospective, multicenter, randomized, double-blind trial.440 acute ischemic stroke (AIS) patients with G6PD deficiency will be randomized to receive a 3-month regimen of aspirin 1...
Eligibility Criteria
Inclusion
- Age≥40 years(no upper limit)
- Acute ischemic stroke within 14 days of symptoms onset;
- Glucose-6-phosphate dehydrogenase deficiency screened in G6PD enzyme activity
- Had not received aspirin 7 days prior to randomization
- Informed consent signed
Exclusion
- Diagnosis of hemorrhage or other pathology, such as vascular malformation, tumor, abscess or other non-ischemic brain disease, base on head CT or MRI
- Concomitant infections at the time of randomization
- mRS\>2 prior to the presenting stroke
- Hemoglobin\<10 g/dL prior to randomization
- Received intravenous thrombolytic therapy or neurointervention treatment before randomization
- Clear indication for anticoagulation (presumed cardioembolism, eg, atrial fibrillation, prosthetic cardiac valves or suspected endocarditis)
- Clear indication for dual antiplatelet therapy (eg, minor stroke in 24h (NIHSS ≤3) or endovascular therapy for the indexed event)
- 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.
- Anticipated concomitant therapy with long-term (\>7 days) NSAIDs affecting platelet function
- 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)
- Any history of thalassemia, autoimmune hemolytic disease, aplastic anemia or other severe hematologic diseases
- Anticipated concomitant therapy with other contraindicated drugs for G6PD deficiency
- Severe dysphagia to unable swallow the drugs
- Concomitant infections and need for antimicrobial therapy
- Intracranial hemorrhage or gastrointestinal bleed within 3 months, or major surgery within 30 days
- Stomach tumor or any other malignant tumor
- Planed surgery or interventional treatment that may affect the study procedure
- Severe non-cardiovascular comorbidity with life expectancy \<3 m
- Female who is pregnant or lactating
- Currently receiving an investigational drug or device
- Inability to understand and/or comply with study procedures due to psychosis, cognition impairment or emotion disturbance.
Key Trial Info
Start Date :
January 22 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
440 Patients enrolled
Trial Details
Trial ID
NCT04088513
Start Date
January 22 2020
End Date
December 31 2024
Last Update
March 16 2022
Active Locations (19)
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1
Longyan First Hospital
Longyan, Fujian, China
2
Sanming First Hospital
Sanming, Fujian, China
3
The First Affiliated Hospital of Guangdong Pharmaceutical University
Guangzhou, Guangdong, China, 510080
4
The First Affiliated Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, China, 510080