Study on the Registration of Coronary Heart Disease Patients Undergoing PCI

NCT02888652 | Completed DMC

• 2 other identifiers: XY3-CLOP1507A01ChiCTR-OOC-16009006
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Heart Disease

Keywords

Coronary Heart Disease; PCI; Anti-Platelet Agents

Outcome Measures

Primary Outcomes (1)

• Major adverse cardiovascular events

  ischemic and bleeding

  within 1 year after PCI

Secondary Outcomes (3)

• Blood drug concentration

  at 5-7 days, 1month, 3 months, 6 months and 12 months after taking anti-platelet agents

• Mild to moderate adverse events

  within 1 year after PCI

• Platelet activity

  at 12- 24 hours, 1 month, 3 months, 6 months and 12 months after PCI

Interventions

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.

Also known as: Clopidogrel or Ticagrelor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients with coronary artery disease treated with aspirin and clopidogrel after successful stent implantation.

You may qualify if:

• 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.

You may not qualify if:

• 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）

Sponsors & Collaborators

• The Third Xiangya Hospital of Central South University: lead

Study Sites (1)

The Third Xiangya Hospital of Central South University

Changsha, Hunan, 410013, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

gene test

MeSH Terms

Conditions

Coronary Disease

Interventions

Ticagrelor; Clopidogrel

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2016
• First Posted: September 5, 2016
• Study Start: September 1, 2015
• Primary Completion: August 1, 2018
• Study Completion: October 1, 2018
• Last Updated: October 14, 2019

Record last verified: 2019-10

Locations

CN (1)