Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

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

Study information

Verified date March 2020
Source Peking University First Hospital
Contact Qian Xaing, Ph.D
Phone +86 010 66110802
Email xiangqz@126.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

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. These patients were enrolled in a previous study, which was approved by the ethics committee of Peking University First Hospital (NO. 2013 [634]). The study investigated the association between genetic polymorphism and clopidogrel pharmacodynamics and drug adverse effect, and enrolled total 168 patients.

The primary endpoints 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 platelet function was assessed using VerifyNow® P2Y12 (VN-P2Y12) assay (Accumetrics, San Diego, California, USA).

To analysis the association of SNP with unplaned revascularization and PRU, the investigators investigated pathways related to known platelet reaction (platelet production, platelet apoptosis, platelet activity, antiplatelet, platelet resistance, platelet adhesion, and etc.) and restenosis-related processes (inflammation, vascular function, proliferation and transcription) from the KEGG, BioCarta and Gene Cards .

The genetic statistical analyses were performed using the set-based test of PLINK v1.07 adjusted by smoking statues. During the set-based test of PLINK the joint effect of all genetic variation, fulfilling the test constraints, within the set of genes of pathway of interest is evaluated. First a single SNP analysis of all SNPs within the pathway set was performed, SNPs with the lowest p-value in the single SNP analysis were selected. This analysis was repeated 10,000 times in simulated datasets, subsequently, a mean SNP statistic was calculated from the single SNP statistics of a maximum amount of independent SNP with a p-value <0.01 SNPs are considered independent when the LD expressed in R2 is lower than 0.5. Analysis of gene mutation distribution conforms to the genetic equilibrium law of Hardy-Weinberg by chi-square test, P <0.05 is considered possible deviations of population distribution. The investigators use the result of 30 month as a replication, SNPs both significant in 18 month and 30 month were reported in the study.


Recruitment information / eligibility

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.

Study Design


Intervention

Other:
clinical restenosis
The primary endpoints is clinical restenosis, the investigators will compared the incidence of clinical restenosis by different smoking status.

Locations

Country Name City State
China Peking University First Hospital Beijing

Sponsors (1)

Lead Sponsor Collaborator
Cui Yimin

Country where clinical trial is conducted

China, 

Outcome

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
See also
  Status Clinical Trial Phase
Recruiting NCT05196659 - Collaborative Quality Improvement (C-QIP) Study N/A
Completed NCT05088291 - Application of a New X-ray Protective Device in Coronary Interventional Therapy
Completed NCT03076801 - Does Choral Singing Help imprOve Stress in Patients With Ischemic HeaRt Disease? N/A
Completed NCT04584645 - A Digital Flu Intervention for People With Cardiovascular Conditions N/A
Not yet recruiting NCT04995159 - Optimized Antiplatelet Therapy in Patients With CHD After Implantation of NeoVas™ BRS System N/A
Recruiting NCT02967718 - Innovation Research of Differentiation and Treatment Methods Based on CHD Phlegm and Blood Stasis Syndrome N/A
Completed NCT02888652 - Study on the Registration of Coronary Heart Disease Patients Undergoing PCI
Completed NCT02163044 - The Hellenic Postprandial Lipemia Study (HPLS)
Terminated NCT02045134 - Supplementation With Polyphenol-Rich Foods and Atrial Fibrillation After a Cardiac Surgery N/A
Active, not recruiting NCT02244853 - Heart Rate and Cardiovascular Diseases Prognosis in People With Stable Coronary Artery Disease N/A
Completed NCT01920009 - Impact of Motivational Interviews Within Pharmacy Care Upon Adherence to Cardiovascular Medicines N/A
Completed NCT02753829 - Home-based Cardiovascular Rehabilitation, Maintenance Phase, in Subjects With Coronary Artery Disease N/A
Completed NCT02440893 - Understanding the Effect of Metformin on Corus CAD (or ASGES)
Terminated NCT01906957 - Cognition and Exercise Training N/A
Completed NCT01826552 - Comparison of the Angiographic Result of the Orsiro Hybrid Stent With Resolute Integrity Stent Phase 4
Recruiting NCT01689688 - Healing Response to Everolimus-eluting Stent Implantation; Serial Assessment With opticaL Coherence Tomography N/A
Completed NCT01779401 - Clopidogrel Response Evaluation and AnTi-Platelet InterVEntion in High Thrombotic Risk PCI Patients N/A
Recruiting NCT01456364 - Intracoronary Stenting and Antithrombotic Regimen: ADjusting Antiplatelet Treatment in PatienTs Based on Platelet Function Testing Phase 4
Recruiting NCT01462799 - COR-PRIM: Problem-based Learning (PBL) After Coronary Heart Disease (CHD) - Long-term Evaluation in Primary Care of Self-care N/A
Completed NCT01486030 - Effect of Exercise Stress Testing on Peripheral Gene Expression Using Corus CAD (or ASGES) Diagnostic Test