Study on the Registration of Coronary Heart Disease Patients Undergoing PCI

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

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.

Study Overview

• Status: Completed
• Conditions: Coronary Heart Disease
• Intervention / Treatment: Drug: antiplatelet agents(Clopidogrel or Ticagrelor)

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.

• Study Type: Observational
• Enrollment (Actual): 1500

Contacts and Locations

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410013
      • The Third Xiangya Hospital of Central South University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

patients with coronary artery disease treated with aspirin and clopidogrel after successful stent implantation.

Description

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）

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: The Third Xiangya Hospital of Central South University
• Investigators: Principal Investigator: GuoPing Yang, professor, The Third Xiangya Hospital of Central South University; Principal Investigator: Yu Cao, MD, The Third Xiangya Hospital of Central South University; Principal Investigator: Jingle Li, MD, The Third Xiangya Hospital of Central South University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2015
• Primary Completion (Actual): August 1, 2018
• Study Completion (Actual): October 1, 2018

Study Registration Dates

• First Submitted: August 11, 2016
• First Submitted That Met QC Criteria: August 30, 2016
• First Posted (Estimate): September 5, 2016

Study Record Updates

• Last Update Posted (Actual): October 14, 2019
• Last Update Submitted That Met QC Criteria: October 9, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: PCI; Coronary Heart Disease; Anti-Platelet Agents
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Ticagrelor; Clopidogrel; Platelet Aggregation Inhibitors
• Other Study ID Numbers: XY3-CLOP1507A01; ChiCTR-OOC-16009006 (Registry Identifier: Chinese Clinical Trial Registry)