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 designed to evaluate the safety and efficacy of aspirin in patients this enzyme disorder.The primary purpose of the trial is to evaluate the hemolytic effects of a 3-month regimen of aspirin 100mg/d versus a 3-month regimen of clopidogrel 75mg/d.
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 100mg/d or clopidogrel 75mg/d. The primary end point is the proportion of protocol-defined hemolysis at 90 days. Protocol-defined hemolysis is defined as one or more of the following conditions: a) Hemoglobin level declined ≥2.5 g/dL from baseline, meanwhile ruling out bleeding events. b) Hemoglobin level declined ≥25% from baseline, meanwhile ruling out bleeding events. c) Clinically relevant hemolytic events, could manifested as fatigue, back pain, anemia, dark urine and jaundice. The study consists of five visits including the day of randomization, day 4, day10±3days, day27±3days, day90±7days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
440
This group will receive a 100 mg/day aspirin plus clopidogrel placebo for 90 days.
This group will receive a 75 mg/day clopidogrel plus aspirin placebo for 90 days.
Longyan First Hospital
Longyan, Fujian, China
Proportion of protocol-defined hemolysis.
Protocol-defined hemolysis is defined as one or more of the following conditions: a) Hemoglobin level declined ≥2.5 g/dL from baseline, meanwhile ruling out bleeding events. b) Hemoglobin level declined ≥25% from baseline, meanwhile ruling out bleeding events. c) Clinically relevant hemolytic events, could manifested as fatigue, back pain, anemia, dark urine and jaundice, adjudicated by the adjudication committee ultimately.
Time frame: 90±5 days.
Change in hemoglobin.
Time frame: 4 days,10±3 days,27±3 days and 90±5 days.
Change in reticulocyte.
Time frame: 4 days,10±3 days,27±3 days and 90±5 days.
Change in unconjugated bilirubin and total bilirubin.
Time frame: 4 days,10±3 days,27±3 days and 90±5 days.
Change in lactic dehydrogenase.
Time frame: 4 days,10±3 days,27±3 days and 90±5 days.
Proportion of major bleed (GUSTO definition).
Time frame: 90±5 days.
Overall mortality.
Time frame: 90±5 days.
Proportion of new clinical vascular events, defined as the composite of stroke, transient ischemic attack (TIA), myocardial infarction and vascular death.
Time frame: 90±5 days.
Proportion of functional independence defined as modified Rankin Scale score 0-2.
Modified Rankin Scale score ranges from 0 to 6, and lower score means more functional independence.
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Sanming First Hospital
Sanming, Fujian, China
RECRUITINGThe First Affiliated Hospital of Guangdong Pharmaceutical University
Guangzhou, Guangdong, China
RECRUITINGThe First Affiliated Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, China
RECRUITINGThe First Affiliated Hospital of Jinan University
Guangzhou, Guangdong, China
NOT_YET_RECRUITINGJieyang Municipal People's Hospital
Jieyang, Guangdong, China
RECRUITINGMeizhou City People's Hospital
Meizhou, Guangdong, China
RECRUITINGYue Bei People's Hospital
Shaoguan, Guangdong, China
NOT_YET_RECRUITINGYunfu People's Hospital
Yunfu, Guangdong, China
NOT_YET_RECRUITINGPeople's Hospital of Baise
Baise City, Guangxi, China
RECRUITING...and 9 more locations
Time frame: 90±5 days.
Proportion of functional independence defined as Barthel Index 95-100.
Barthel Index ranges from 0 to 100, and higher score means more functional independence.
Time frame: 90±5 days.
Change in National Institutes of Health Stroke Scale
National Institutes of Health Stroke Scale ranges from 0 to 42, and higher scores indicate more severe neurologic deficits.
Time frame: 90±5 days.
Health related quality of life, assessed by EuroQoL-5 Dimensions questionnaire
EuroQoL-5 Dimensions questionnaire contains utility index score and visual analogue scale. Utility index score ranges from 0 to 1, and visual analogue scale ranges from 0 to 100. Higher scores indicate more healthy quality of life.
Time frame: 90±5 days.