Study on the Registration of Coronary Heart Disease Patients Undergoing PCI

NCT ID: NCT02888652

Last Updated: 2019-10-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2018-10-31

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.

Conditions

Coronary Heart Disease

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Clopidogrel or Ticagrelor

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）

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Third Xiangya Hospital of Central South University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GuoPing Yang, professor

Role: PRINCIPAL_INVESTIGATOR

The Third Xiangya Hospital of Central South University

Yu Cao, MD

Role: PRINCIPAL_INVESTIGATOR

The Third Xiangya Hospital of Central South University

Jingle Li, MD

Role: PRINCIPAL_INVESTIGATOR

The Third Xiangya Hospital of Central South University

Locations

The Third Xiangya Hospital of Central South University

Changsha, Hunan, China

Countries

China

Other Identifiers

ChiCTR-OOC-16009006

Identifier Type: REGISTRY

Identifier Source: secondary_id

XY3-CLOP1507A01

Identifier Type: -

Identifier Source: org_study_id