Clinical trial NCT02888652: Study on the Registration of Coronary Heart Disease Patients Undergoing PCI
Official title: Multivariate Analysis of Platelet Reactivity Variety in Patients With Coronary Heart Disease After PCI
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Heart Disease
Keywords: Coronary Heart Disease
PCI
Anti-Platelet Agents
Lead sponsor: The Third Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2016-09-05
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with coronary artery disease treated with aspirin and clopidogrel after successful stent implantation.

Brief summary: 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: 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.

Eligibility criteria: 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）

Primary outcomes:
measure: Major adverse cardiovascular events
timeFrame: within 1 year after PCI
Secondary outcomes:
measure: Blood drug concentration
timeFrame: at 5-7 days, 1month, 3 months, 6 months and 12 months after taking anti-platelet agents
measure: Mild to moderate adverse events
timeFrame: within 1 year after PCI
measure: Platelet activity
timeFrame: at 12- 24 hours, 1 month, 3 months, 6 months and 12 months after PCI
Other outcomes:
Locations:
city: Changsha
country: China
facility: The Third Xiangya Hospital of Central South University
state: Hunan
Study officials:
affiliation: The Third Xiangya Hospital of Central South University
name: GuoPing Yang, professor
role: PRINCIPAL_INVESTIGATOR
affiliation: The Third Xiangya Hospital of Central South University
name: Yu Cao, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Third Xiangya Hospital of Central South University
name: Jingle Li, MD
role: PRINCIPAL_INVESTIGATOR
References: