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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

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.

Condition or disease Intervention/treatment
Coronary Heart Disease 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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 1500 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Multivariate Analysis of Platelet Reactivity Variety in Patients With Coronary Heart Disease After PCI
Actual Study Start Date : September 2015
Actual Primary Completion Date : August 2018
Actual Study Completion Date : October 2018

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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


Primary Outcome Measures :
  1. Major adverse cardiovascular events [ Time Frame: within 1 year after PCI ]
    ischemic and bleeding


Secondary Outcome Measures :
  1. 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

  2. Mild to moderate adverse events [ Time Frame: within 1 year after PCI ]
    renal function

  3. Platelet activity [ Time Frame: at 12- 24 hours, 1 month, 3 months, 6 months and 12 months after PCI ]
    Platelet activity


Biospecimen Retention:   Samples With DNA
gene test


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients with coronary artery disease treated with aspirin and clopidogrel after successful stent implantation.
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02888652


Locations
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China, Hunan
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China, 410013
Sponsors and Collaborators
The Third Xiangya Hospital of Central South University
Investigators
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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

Additional Information:

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Responsible Party: The Third Xiangya Hospital of Central South University
ClinicalTrials.gov Identifier: NCT02888652     History of Changes
Other Study ID Numbers: XY3-CLOP1507A01
ChiCTR-OOC-16009006 ( Registry Identifier: Chinese Clinical Trial Registry )
First Posted: September 5, 2016    Key Record Dates
Last Update Posted: October 14, 2019
Last Verified: October 2019
Keywords provided by The Third Xiangya Hospital of Central South University:
Coronary Heart Disease
PCI
Anti-Platelet Agents
Additional relevant MeSH terms:
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Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Clopidogrel
Ticagrelor
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs