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OpenTrials
Completed

NCT Number: NCT02888652

Study on the Registration of Coronary Heart Disease Patients Undergoing 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Third Xiangya Hospital of Central South University

Changsha, Hunan, 410013, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

antiplatelet agents(Clopidogrel or Ticagrelor)

Drug

Clinical physicians according to patients condition to give different antiplatelet agents(Clopidogrel or Ticagrelor).We only observe clinical curative effect.

Other names: Clopidogrel or Ticagrelor

Primary outcomes

  1. Major adverse cardiovascular events

    Time frame: within 1 year after PCI

    ischemic and bleeding

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

The Third Xiangya Hospital of Central South University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Sep 5, 2016
Registry last updated
Oct 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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