Coronary Heart Disease Clinical Trial
Official title:
Effect of Smoking Status and Genetic Risk Factors on Restenosis and Efficacy of Clopidogrel After de Novo Percutaneous Coronary Intervention
NCT number | NCT03613337 |
Other study ID # | PCI71 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | May 1, 2018 |
Est. completion date | August 31, 2020 |
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.
Status | Recruiting |
Enrollment | 120 |
Est. completion date | August 31, 2020 |
Est. primary completion date | July 31, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: 1. Post percutaneous coronary intervention (PCI) patients; 2. 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) . Exclusion Criteria: 1. Patients with cancer, viral hepatitis and other related diseases; 2. The clinical data are incomplete. |
Country | Name | City | State |
---|---|---|---|
China | Peking University First Hospital | Beijing |
Lead Sponsor | Collaborator |
---|---|
Cui Yimin |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Platelet reaction | Platelet reaction (VerifyNow method) 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 the values will be compared by different smoking status. | 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 |
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