Study on the Registration of Coronary Heart Disease Patients Undergoing PCI

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Multivariate Analysis of Platelet Reactivity Variety in Patients With Coronary Heart Disease After PCI

Conditions
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Coronary Heart Disease

Intervention / Treatment
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* Drug: antiplatelet agents(Clopidogrel or Ticagrelor)


Participation Criteria
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Eligibility Criteria
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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）

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse cardiovascular events | ischemic and bleeding | within 1 year after PCI | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PCI, Coronary Heart Disease, Anti-Platelet Agents