UnknownPhase 4

Safety and Efficacy of Aspirin in Stroke Patients With Glucose-6-phosphate Dehydrogenase Deficiency (SAST)

China440 participantsStarted 2020-01-22

Plain-language 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 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.

Who can participate

Age range40 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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.

What they're measuring

Proportion of protocol-defined hemolysis.

Timeframe: 90±5 days.

Trial details

NCT IDNCT04088513

SponsorFirst Affiliated Hospital, Sun Yat-Sen University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-31

Contact for this trial

Jinsheng Zeng, MD,PhD

13322800657 zengjs@pub.guangzhou.gd.cn

View on ClinicalTrials.gov More G6PD Deficiency trials