Smoking StatusNCT03613337
Effect of Smoking Status and Genetic Risk Factors on Restenosis and Efficacy of Clopidogrel After de Novo Percutaneous Coronary Intervention
An observational study of Smoking Status and Genetic Risk Factors, run by Cui Yimin at 1 site in China.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Smoking Status, Genetic Risk Factors, Restenosis
- What is being tested?
- clinical restenosis
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2018to 31 Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- 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) .
Who cannot join
- Patients with cancer, viral hepatitis and other related diseases;
- The clinical data are incomplete.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University First Hospital
Beijing, 100034
Qian Xiang, PhD
About this study
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.
Read the detailed 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.
- Conditions
- Smoking Status, Genetic Risk Factors, Restenosis, Clopidogrel, Coronary Heart Disease, Percutaneous Coronary Intervention
- Being tested
- clinical restenosis
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clinical restenosisOther
The primary endpoints is clinical restenosis, the investigators will compared the incidence of clinical restenosis by different smoking status.
| Study group | Role | What they receive |
|---|---|---|
| current smokers | Current smokers are those who continued smoking cigarettes more than 1 cigarette pre month after first percutaneous coronary intervention (PCI) . Receives: Other: clinical restenosis | |
| nonsmokers | Nonsmokers are those who never smoked in their lifetime. Receives: Other: clinical restenosis | |
| 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) Receives: Other: clinical restenosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: follow up time from 1 to 5 years
Secondary outcomes (1)
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2018
- Study start1 May 2018
- Primary completion31 Jul 2020 (estimated)
- Study completion31 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking StatusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cui Yimin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Cui Yimin, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03613337
- Sponsor's protocol ID
- PCI71
- Status last verified
- Mar 2020
- First submitted
- 11 Jul 2018
- Last updated
- 3 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Smoking Status and Genetic Risk Factors on Restenosis and Efficacy of Clopidogrel After de Novo Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT03613337
- Acronym / sponsor ID
- PCI71
- Conditions
- Smoking Status, Genetic Risk Factors, Restenosis, Clopidogrel, Coronary Heart Disease, Percutaneous Coronary Intervention
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Cui YiminUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 31 Jul 2020 (estimated)
- Study completion
- 31 Aug 2020 (estimated)
- First posted
- 3 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| current smokers | – | Other: clinical restenosisCurrent smokers are those who continued smoking cigarettes more than 1 cigarette pre month after first percutaneous coronary intervention (PCI) . |
| nonsmokers | – | Other: clinical restenosisNonsmokers are those who never smoked in their lifetime. |
| former smokers | – | Other: clinical restenosisFormer 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) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (2 listed)
- 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) .
Key exclusion criteria (2 listed)
- Patients with cancer, viral hepatitis and other related diseases;
- The clinical data are incomplete.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| clinical restenosisThe primary endpoints is clinical restenosis, the investigators will compared the incidence of clinical restenosis by different smoking status. | Other | current smokers, former smokers, nonsmokers |
Primary outcome
clinical restenosis
Time frame: follow up time from 1 to 5 years
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.
1 secondary outcome
Platelet reaction
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Smoking Status and Genetic Risk Factors, run by Cui Yimin at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qian Xaing, Ph.D (+86 010 66110802, xiangqz@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical restenosis (time frame: follow up time from 1 to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2020.