Study on the Registration of Coronary Heart Disease Patients Undergoing PCI

Central South University

Status: Completed

Conditions: Coronary Heart Disease

Treatments: Drug: antiplatelet agents(Clopidogrel or Ticagrelor)

Study type: Observational

Funder types: Other

Identifiers

NCT02888652

XY3-CLOP1507A01

ChiCTR-OOC-16009006 (Registry Identifier)

Details and patient eligibility

About

Study on the registration of coronary heart disease patients undergoing PCI in Chinese's population. Get the incidence of adverse events in these patients after PCI, a clear type of adverse reaction, forms, influencing factors, to establish risk management processes, clinical safety and reasonable treatment, and provide the basis for further research and reference.

Full description

Dual antiplatelet therapy, comprising a low-dose aspirin and a kind of P2Y12 Receptor Inhibitors, has been the mainstay of the management in patients with acute coronary syndromes and/or undergoing Percutaneous Coronary Intervention (PCI). While variability to P2Y12 receptor inhibitors is common in patients and is a major cause of adverse cardiovascular events. Low response to P2Y12 receptor inhibitors will result high platelet reactivity (HPR) and patients who exhibit HPR are at increased risk of atherothrombotic occlusion events. Vice versa, high response to P2Y12 receptor inhibitors will lead to low platelet reactivity (LPR) and increase the risk of hemorrhage.Now, the absence of a universal definition of therapeutic window for different racial and actual clinical situations and lacking the gold standard test to quantify it limit the use in clinic practice.So this clinical trial try to use patient's platelet reactivity combine with type of adverse reaction, forms, influencing factors to find a proper therapeutic windows for P2Y12 receptor inhibitors in Chinese people.

Enrollment: 1,500 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Chinese's patients diagnosed with coronary heart disease and accept stent implantation.
• Accept aspirin and P2Y12 receptor inhibitors (clopidogrel or ticagrelorwere）after stent implantation.
• Willingness and ability to sign informed consent.
• Can communicate effectively and complete the trial.

Exclusion criteria

• Occurrence of a major complication during the procedure of percutaneous coronary intervention or before platelet function testing.
• Allergy or intolerance to aspirin or P2Y12 receptor inhibitors (Clopidogrel or Ticagrelor）