Skip to content

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02888652
Enrollment
1500
Registered
2016-09-05
Start date
2015-09-30
Completion date
2018-10-31
Last updated
2019-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Heart Disease

Keywords

Coronary Heart Disease, PCI, Anti-Platelet Agents

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.

Interventions

DRUGantiplatelet agents(Clopidogrel or Ticagrelor)

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

Sponsors

The Third Xiangya Hospital of Central South University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Major adverse cardiovascular eventswithin 1 year after PCIischemic and bleeding

Secondary

MeasureTime frameDescription
Blood drug concentrationat 5-7 days, 1month, 3 months, 6 months and 12 months after taking anti-platelet agentsClopidogrel and Ticagrelor
Mild to moderate adverse eventswithin 1 year after PCIrenal function
Platelet activityat 12- 24 hours, 1 month, 3 months, 6 months and 12 months after PCIPlatelet activity

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026