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Investigation on the effects of genetic polymorphisms and epigenetic modifications in gene encoding P2Y12 receptor signaling molecule on antiplatelet activity and clinical efficacy of clopidogrel

Investigation on the effects of genetic polymorphisms and epigenetic modifications in gene encoding P2Y12 receptor signaling molecule on antiplatelet activity and clinical efficacy of clopidogrel

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OPN-15006260
Enrollment
Unknown
Registered
2015-04-13
Start date
2015-05-18
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

acute coronary syndromes

Interventions

Patients with acute coronary syndrome:Patients were administered 300mg loading dose of clopidogrel before PCI and received a 75-mg/d maintenance dosage of clopidogrel and 100 mg/d of aspirin for a yea

Sponsors

Institute of Clinical Pharmacology, Central South University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. diagnosed with acute coronary syndrome (medium to high risk) and schduled for primary PCI; 2. received combined therapy with aspirin and clopidogrel at least for 12 months after PCI; 3. male or non pregnant women aged 18-80 years old; 4. signed informed consent and agree to follow the requirements of study.

Exclusion criteria

Exclusion criteria: 1. Cardiogenic shock at the time of randomization; 2. Refractory ventricular arrhythmias; 3. New York Heart Association class IV congestive heart failure; 4. Fibrin-specific fibrinolytic therapy less than 24 h before randomization; 5. Non-fibrin-specific fibrinolytic therapy less than 48 h before randomization; 6. Active internal bleeding or history of bleeding diathesis; 7. Clinical findings, in the judgment of the investigator, associated with an increased risk of bleeding; 8. Any of the following: a) History of hemorrhagic stroke; b) Intracranial neoplasm, arteriovenous malformation, or aneurysm; c) Ischemic stroke within 3 months prior to screening; 9. International normalized ratio known to be greater than 1.5 at the time of screening; 10. Platelet count of less than 100000/mm3 at the time of screening; 11. Anemia (hemoglobin <10 g/dL) at the time of screening; 12. Oral anticoagulation or other antiplatelet therapy that cannot be safely discontinued for the duration of the study; 13. Daily treatment with nonsteroidal antiinflammatory drugs or cyclooxygenase-2 inhibitors; 14. Women who are known to be pregnant, have given birth within the past 90 d, or are breast-feeding; 15. Known severe hepatic dysfunction; 16. Any condition associated with poor treatment compliance, including alcoholism, mental illness, or drug dependence; 17. Intolerance of or allergy to aspirin or ticagrelor; 18. May be unable to cooperate with protocol requirements and follow-up procedures.

Design outcomes

Primary

MeasureTime frame
cardiovascular death;nonfatal myocardial infarction;nonfatal stroke;urgent target vessel revascularization;stent thrombosis;Platelet aggregation;VASP-P;

Countries

China

Contacts

Public ContactChen Xiao-Ping
chenxp74@hotmail.com+86 13875803018

Outcome results

None listed

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