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Comparison of Cilostazol versus Clopidogrel in Addition to Aspirin in Patients with cute minor ischemic stroke with CYP2C19 gene function deficiency: A multicenter, open label, and efficacy randomized controlled study

Comparison of Cilostazol versus Clopidogrel in Addition to Aspirin in Patients with cute minor ischemic stroke with CYP2C19 gene function deficiency: A multicenter, open label, and efficacy randomized controlled study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400091121
Enrollment
Unknown
Registered
2024-10-21
Start date
2024-10-22
Completion date
Unknown
Last updated
2024-10-28

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

Conditions

Ischemic stroke

Interventions

Control group:Clopidogrel+Aspirin
Experimental group:Cilostazol +aspirin

Sponsors

Affiliated Hospital of Guangdong Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. 18 = Age<80 years old, gender not limited; 2. Clinical and imaging (CT and MRI), except for cerebral hemorrhage or space occupying lesions; 3. (1) Non cardiogenic acute cerebral infarction with onset time less than 24 hours and NIHSS score = 5 points; (2) Patients who have not received intravenous thrombolysis and/or mechanical thrombectomy; 4. First onset or previous stroke without significant sequelae (mRS = 1); 5.Understand and sign the informed consent form

Exclusion criteria

Exclusion criteria: 1) Coma (patients with NIHSS 1a consciousness level score>1); 2) Moderate to severe stroke symptoms (NIHSS>6 points); 3) Pseudo medullary paralysis with swallowing difficulties; 4) Intracranial hemorrhagic diseases seen on head CT: cerebral hemorrhage, intraventricular hemorrhage, subarachnoid hemorrhage, subdural or epidural hematoma; 5) History of cerebral hemorrhage, subarachnoid hemorrhage, cerebral arteriovenous malformation or cerebral aneurysm, or brain tumor in the past; 6) The following serious internal medicine complications: uncontrolled hypertension, consistently above 200/110mmHg; Severe liver disease (ALT or AST>2 times the upper limit of normal, or total bilirubin>20mmol/L, or acute hepatitis, chronic active hepatitis, cirrhosis); Severe kidney disease (renal insufficiency) 7) Contraindications for clopidogrel, cilostazol, or aspirin: including allergies, severe renal or liver dysfunction, history of thrombocytopenia or platelet count<100 x10 9/L, history of coagulation disorders or systemic bleeding disorders; 8) Patients with cardiogenic ischemic stroke, or those currently taking anticoagulant drugs and requiring anticoagulant therapy during the study period; 9) Gastrointestinal bleeding, urinary system bleeding, or major surgical procedures in the past 3 months; 10) Pregnant or lactating women, as well as those planning to become pregnant during the entire trial period and women in their menstrual cycle; 11) Individuals with mental symptoms who are unable to cooperate; 12) Have participated in other clinical trials within 30 days prior to the date of obtaining informed consent, or are currently participating in other clinical trials; 13) Other researchers believe that it is not suitable to participate in this clinical trial.

Design outcomes

Primary

MeasureTime frame
The proportion of new stroke events (ischemic or hemorrhagic) occurring within 3 months;

Secondary

MeasureTime frame
The proportion of patients with good neurological function prognosis (mRS 0-1) after 3 months;3-month EQ-VAS scale score;3-month BI Score;Proportion of early neurological function improvement (NIHSS score reduction = 2 points) within 48 hours;Proportion of early neurological function improvement (NIHSS score increase = 4 points) within 48 hours;

Countries

China

Contacts

Public ContactZhong Wangtao

Affiliated Hospital of Guangdong Medical University

158980116@qq.com+86 759 239 8427

Outcome results

None listed

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