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Study on the Registration of Coronary Heart Disease Patients Undergoing PCI

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ClinicalTrials.gov Identifier: NCT02888652
Recruitment Status : Completed
First Posted : September 5, 2016
Last Update Posted : October 14, 2019
Sponsor:
Information provided by (Responsible Party):
The Third Xiangya Hospital of Central South University

Tracking Information
First Submitted Date August 11, 2016
First Posted Date September 5, 2016
Last Update Posted Date October 14, 2019
Actual Study Start Date September 2015
Actual Primary Completion Date August 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 9, 2019)
Major adverse cardiovascular events [ Time Frame: within 1 year after PCI ]
ischemic and bleeding
Original Primary Outcome Measures
 (submitted: August 30, 2016)
Major adverse cardiovascular events [ Time Frame: within 1 year after PCI ]
Change History Complete list of historical versions of study NCT02888652 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: October 9, 2019)
  • 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
Original Secondary Outcome Measures
 (submitted: August 30, 2016)
  • Blood drug concentration [ Time Frame: at 5-7 days, 1month, 3 months, 6 months and 12 months after taking anti-platelet agents ]
  • Mild to moderate adverse events [ Time Frame: within 1 year after PCI ]
  • Platelet activity VASP/P2Y12 [ Time Frame: at 12- 24 hours, 1 month, 3 months, 6 months and 12 months after PCI ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.
Study Type Observational [Patient Registry]
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration 1 Year
Biospecimen Retention:   Samples With DNA
Description:
gene test
Sampling Method Probability Sample
Study Population patients with coronary artery disease treated with aspirin and clopidogrel after successful stent implantation.
Condition Coronary Heart Disease
Intervention 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.
Other Name: Clopidogrel or Ticagrelor
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 9, 2019)
1500
Original Estimated Enrollment
 (submitted: August 30, 2016)
1000
Actual Study Completion Date October 2018
Actual Primary Completion Date August 2018   (Final data collection date for primary outcome measure)
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)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT02888652
Other Study ID Numbers XY3-CLOP1507A01
ChiCTR-OOC-16009006 ( Registry Identifier: Chinese Clinical Trial Registry )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party The Third Xiangya Hospital of Central South University
Study Sponsor The Third Xiangya Hospital of Central South University
Collaborators Not Provided
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
PRS Account The Third Xiangya Hospital of Central South University
Verification Date October 2019