Study on the Registration of Coronary Heart Disease Patients Undergoing PCI

Overview

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 Title of Study: “Multivariate Analysis of Platelet Reactivity Variety in Patients With Coronary Heart Disease After PCI”

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: August 2018

Detailed 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.

Interventions

  • Drug: antiplatelet agents(Clopidogrel or Ticagrelor)
    • Clinical physicians according to patients condition to give different antiplatelet agents(Clopidogrel or Ticagrelor).We only observe clinical curative effect.

Clinical Trial Outcome Measures

Primary Measures

  • Major adverse cardiovascular events
    • Time Frame: within 1 year after PCI
    • ischemic and bleeding

Secondary Measures

  • Blood drug concentration
    • Time Frame: at 5-7 days, 1month, 3 months, 6 months and 12 months after taking anti-platelet agents
    • Clopidogrel and Ticagrelor
  • Mild to moderate adverse events
    • Time Frame: within 1 year after PCI
    • renal function
  • Platelet activity
    • Time Frame: at 12- 24 hours, 1 month, 3 months, 6 months and 12 months after PCI
    • Platelet activity

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • The Third Xiangya Hospital of Central South University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • GuoPing Yang, professor, Principal Investigator, The Third Xiangya Hospital of Central South University
    • Yu Cao, MD, Principal Investigator, The Third Xiangya Hospital of Central South University
    • Jingle Li, MD, Principal Investigator, The Third Xiangya Hospital of Central South University

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