Effect of Smoking Status and Genetic Risk Factors on Restenosis and Efficacy of Clopidogrel After de Novo Percutaneous Coronary Intervention
1 other identifier
observational
120
1 country
1
Brief Summary
Restenosis occurs for many different reasons. Over the years, many predictive clinical, biological, genetic, epigenetic, lesion-related, and procedural risk factors for restenosis have been identified. Smoking is one of most important factors, however the results were contradictory. And the genetic factors of restenosis have been studied mostly in European populations. Based on literature review, study of candidate genes for restenosis in Chinese population was insufficient. With due attention to this matter mentioned above, the investigators aim to preliminary explore genetic variation and smoking effect on clinical restenosis in patients diagnosed with after percutaneous coronary intervention in the Chinese population, with correlation analysis of factors and gene-set analysis of biological pathways related to restenosis and platelet approach were widely used in this study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2018
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2018
CompletedFirst Submitted
Initial submission to the registry
July 11, 2018
CompletedFirst Posted
Study publicly available on registry
August 3, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2020
CompletedMarch 3, 2020
March 1, 2020
2.3 years
July 11, 2018
March 1, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
clinical restenosis
Clinical restenosis, defined as unplaned revascularization including arget vessel revascularization (TVR) or target lesion revascularization (TLR) , either by repeated percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG). The investigators will record the incidence of clinical restenosis events above through the medical record system, and compared the incidence through different smoking status.
follow up time from 1 to 5 years
Secondary Outcomes (1)
Platelet reaction
Platelet function was detected after the clopidogrel efficiency reached homeostasis (clopidogrel 75mg daily for more than 7 days, or 300mg loading dose and 75mg daily for 5 days, or 600mg loading dose with 75mg for 3 days, and within 1 year after PCI
Study Arms (3)
current smokers
Current smokers are those who continued smoking cigarettes more than 1 cigarette pre month after first percutaneous coronary intervention (PCI) .
nonsmokers
Nonsmokers are those who never smoked in their lifetime.
former smokers
Former smokers are those who had quit smoking after percutaneous coronary intervention (PCI) , and smoked less than 1 cigarette pre month after first percutaneous coronary intervention (PCI)
Interventions
The primary endpoints is clinical restenosis, the investigators will compared the incidence of clinical restenosis by different smoking status.
Eligibility Criteria
The design of the study was retrospective study using secondary data from medical records of coronary heart disease patients who taking antiplatelet drugs and had genetic test at Peking University First Hospital.
You may qualify if:
- Post percutaneous coronary intervention (PCI) patients;
- Patients received Dual antiplatelet therapy consisted of 100mg of aspirin daily and 75 mg of clopidogrel for at least 1 year after de novo percutaneous coronary intervention (PCI) ; If the end point occurred within 1 years, patients should use dual antiplatelet therapy during the period from the first to second percutaneous coronary intervention (PCI) .
You may not qualify if:
- Patients with cancer, viral hepatitis and other related diseases;
- The clinical data are incomplete.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cui Yiminlead
Study Sites (1)
Peking University First Hospital
Beijing, 100034, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Director of pharmacy，M.D & Ph.D
Study Record Dates
First Submitted
July 11, 2018
First Posted
August 3, 2018
Study Start
May 1, 2018
Primary Completion
July 31, 2020
Study Completion
August 31, 2020
Last Updated
March 3, 2020
Record last verified: 2020-03