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The efficacy and safety of aspirin in ischemic stroke with G6PD deficiency: a prospective, multi-center, and randomized controlled trial

The efficacy and safety of aspirin in ischemic stroke with G6PD deficiency: a prospective, multi-center, and randomized controlled trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800020026
Enrollment
Unknown
Registered
2018-12-12
Start date
2019-03-01
Completion date
Unknown
Last updated
2018-12-18

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

Conditions

G6PD deficiency

Interventions

One:aspirin (100 mg/d)
Two:clopidogrel (75 mg/d)

Sponsors

The First Affiliated Hospital, Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Aged =18 years old; 2. Ischemic stroke within 14 days from symptom onset; 3. First-ever ischemic stroke or recurrent event with modified Rankin Scale (mRS) score =1 before onset; 4. G6PD deficiency; 5. Providing written informed consent.

Exclusion criteria

Exclusion criteria: 1. Definite indications for anticoagulation therapy; 2. mRS =2 before onset; 3. Having taken aspirin or clopidogrel 30 days before randomization; 4. With autoimmune hemolytic disease; 5. With thalassemia, megaloblastic anemia, iron-deficiency anemia and other hematological diseases; 6. With contraindication for aspirin or clopidogrel; 7. Expect to use of drugs banned or carefully used in G6PD deficiency patients other than aspirin; 8. Hemorrhagic stroke or other brain pathological diseases; 9. Severe liver diseases (transaminase elevation up to 1.5 times the upper limit of normal value) and malignant tumors; 10. A history of gastrointestinal bleeding or major surgery within 3 months prior to randomization; 11. Surgical or endovascular treatment is expected in the next three months; 12. Other planned surgical or interventional treatments may require discontinuation of the use of experimental drugs; 13. With severe non-cardio-cerebrovascular diseases, the expected survival time is less than 3 months; 14. Pregnant or lactating women; 15. Participating in other experimental drugs or instruments trials; 16. Participated in other clinical drug research in the past 30 days; 17. Failure to understand and comply with research procedures and follow-up due to mental disorders, cognitive or emotional disorders.

Design outcomes

Primary

MeasureTime frame
Stroke;acute hemolysis;

Secondary

MeasureTime frame
Combined vascular events (ischemic stroke, hemorrhagic stroke, transient ischemic attack, myocardial infarction and vascular death);modified Rankin Scale score;Changes of hemolysis-related hematological parameters (erythrocyte count, hemoglobin, total bilirubin, direct bilirubin and indirect bilirubin);Major bleeding;intracranial hemorrhage;all-cause death;

Countries

China

Contacts

Public ContactZeng Jinsheng

The First Affiliated Hospital, Sun Yat-sen University

zengjs@pub.guangzhou.gd.cn+86 13322800657

Outcome results

None listed

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