Study on the Registration of Coronary Heart Disease Patients Undergoing PCI

Coronary Heart Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02888652
• Other study ID #: XY3-CLOP1507A01
• Secondary ID: ChiCTR-OOC-16009
• Status: Completed
• Start date: September 2015
• Est. completion date: October 2018

Study information

• Verified date: October 2019
• Source: The Third Xiangya Hospital of Central South University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1500
• Est. completion date: October 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Myocardial Ischemia

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.

Locations

Country	Name	City	State
China	The Third Xiangya Hospital of Central South University	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
The Third Xiangya Hospital of Central South University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major adverse cardiovascular events	ischemic and bleeding	within 1 year after PCI
Secondary	Blood drug concentration	Clopidogrel and Ticagrelor	at 5-7 days, 1month, 3 months, 6 months and 12 months after taking anti-platelet agents
Secondary	Mild to moderate adverse events	renal function	within 1 year after PCI
Secondary	Platelet activity	Platelet activity	at 12- 24 hours, 1 month, 3 months, 6 months and 12 months after PCI