TicagrelorNCT03161002
Impact of Biomarkers on Pharmacokinetics and Pharmacodynamics of Ticagrelor
An observational study of Ticagrelor and Pharmacokinetics, run by Cui Yimin at 7 sites in China.
Trial summary
It is general that there are many factors for individual differences of drugs in clinical application, of which genetic factors accounted for more than 20%. Ticagrelor is a new-type receptor antagonist of P2Y12 and it is not affected by the influence of CYP2C19 polymorphism. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ticagrelor, Pharmacokinetics, Pharmacodynamics
- What is being tested?
- detection of genotype
- How many people
- 400 participants
- Where
- 7 sitesChina
- Study dates
- 31 May 2017to Dec 2021
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: (I)Chinese Healthy Volunteers：In accordance with the criteria of each bioequivalence trial of ticagrelor；150-200 cases (II)Chinese Patients：With diagnosis of acute coronary syndrome (ACS)，never received ticagrelor in a month and intend to take ticagrelor or have received ticagrelor for more than one week continuously；200 cases
Who may be able to join
- (I)Chinese Healthy Volunteers
- In accordance with the inclusion criteria for each bioequivalence trial of ticagrelor;
- Sign informed consent of the research;
- Complete to collect indexes of pharmacodynamics and pharmacogenomics in the cycle with control drug.
- (II)Chinese Patients
- With diagnosis of acute coronary syndrome (ACS), included unstable angina, non ST segment elevation myocardial infarction and ST segment elevation myocardial infarction;
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- More than 18 years of age, male or female;
- Never received ticagrelor in a month and intend to take ticagrelor or have received ticagrelor for more than one week continuously；
- sign informed consent.
Who cannot join
- (I)Chinese Healthy Volunteers
- In accordance with the exclusion criteria for each bioequivalence trial of ticagrelor;
- (II)Chinese Patients
- With history of immunodeficiency disease, including positive HIV index;
- Positive Hepatitis B surface antigen (HBsAg) and HCV index;
- Combined therapy of CYP3A potent inhibitors (e.g., ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, Atazanavir, etc.), CYP3A substrate of narrow therapy window (e.g., cyclosporine, quinidine, etc.) and potent inducers of CYP3A (e.g., rifampin, phenytoin, carbamazepine, etc.) in 14 days before treatment with ticagrelor;
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- Severe liver dysfunction and abnormal renal function;
- Uncontrolled hypertension, or systolic blood pressure > 180mmHg or diastolic pressure > 110mmHg during screening;
- Include contraindications of ticagrelor, such as hypersensitivity, active bleeding, moderate or severe liver disease, previous history of intracranial hemorrhage, gastrointestinal hemorrhage in the past 6 months and major operation within 30 days.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites, 4 recruiting
- Recruiting
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Qian Xiang, Ph.D, +86 010 66110802, xiangqz@126.com
- Active, not recruiting
The Third Xiangya Hospital of Central South University
Changsha, Hunan
- Recruiting
900 Hospital of the Joint Logistics Team (Original name: Fuzhou General Hospital of Nanjing Militray Command)
Fuzhou, Fujian
Zhihong Liu, liuzh827@sina.cn
- Recruiting
Anhui Provincial Hospital（The First Affiliated Hospital Of USTC）
Hefei, Anhui, 230001
Zhaoyi Yang, PhD, +86-0551-62283379-800, young2382@163.com
- Recruiting
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230001
Yan Huang, MS, +86-15056922343, hyayd123@126.com
- Active, not recruiting
The Second Affiliated Hospital Of Nanchang University
Nanchang, Jiangxi, 330006
- Active, not recruiting
The 7th People's Hospital Of Zhengzhou
Zhengzhou, Henan, 450006
About this study
It is general that there are many factors for individual differences of drugs in clinical application, of which genetic factors accounted for more than 20%. Ticagrelor is a new-type receptor antagonist of P2Y12 and it is not affected by the influence of CYP2C19 polymorphism. With lack of predicted biomarkers, especially the research data of Chinese, it has the important significance in studying individual differences of ticagrelor in the antiplatelet efficacy and safety, through the pharmacogenomics research.
The aim of this study is to determine the polymorphism of drug metabolizing enzymes, drug transporters and drug target genes in Chinese population. By detecting the gene polymorphism, we intend to study the pharmacokinetic/ pharmacodynamics/ pharmacogenomics (PK-PD-PG) correlation of ticagrelor and provide scientific basis for accurate medication guide for people to use ticagrelor.
- Being tested
- detection of genotype
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
detection of genotypeGenetic
detection of genotype by next generation sequencing
| Study group | Role | What they receive |
|---|---|---|
| wild genotype | Through next generation sequencing, distinguish wild genotype of ticagrelor Receives: Genetic: detection of genotype | |
| mutant genotype | Through next generation sequencing, distinguish mutant genotype of ticagrelor Receives: Genetic: detection of genotype |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of major adverse cardiac events (MACE)
During the observation time, record the incidence of MACE after ticagrelor administration by telephone or outpatient clinic , including myocardial infarction, cardiac death, stent stenosis, stent thrombosis, ect.
Measured: At 1 year
Incidence of bleeding events
During the observation time, record the incidence of bleeding events after ticagrelor administration by telephone or outpatient clinic, including subcutaneous bleeding, gingival bleeding, gastrointestinal bleeding, intracranial hemorrhage, etc.
Measured: At 1 year
Secondary outcomes (8)
genotype detected by next generation sequencing
Collect blood specimen before ticagrelor administration, then detect genotype of Ticagrelor by next generation sequencing.
Measured: pre-dose of Ticagrelor
Level of platelet reactivity assessed by ADP aggregation rate
Before and after ticagrelor administration, record the ADP aggregation rate detected by Light Transmittance Aggregometry(LTA).
Measured: At baseline, at 12 hours for Chinese healthy volunteers or at 48 hours for Chinese patients.
Level of platelet reactivity assessed by PRI
Before and after ticagrelor administration, record PRI detected by VerifyNow System.
Measured: At baseline, at 12 hours for Chinese healthy volunteers or at 48 hours for Chinese patients.
Expression level of miRNA
Before and after ticagrelor administration, detect the expression level of miRNA about pharmacodynamics.
Measured: At baseline, at 12 hours for Chinese healthy volunteers or at 48 hours for Chinese patients.
Expression level of proteomics
Before and after ticagrelor administration, detect the expression level of proteomics about pharmacodynamics
Measured: At baseline, at 12 hours for Chinese healthy volunteers or at 48 hours for Chinese patients
Expression level of LncRNA
Before and after ticagrelor administration, detect the expression level of LncRNA about pharmacodynamics.
Measured: At baseline, at 12 hours for Chinese healthy volunteers；at 48 hours for Chinese patients.
Incidence of MACEs in the other observation times
During the other observation time, record the incidence of MACE after ticagrelor administration by telephone or outpatient clinic , including myocardial infarction, cardiac death, stent stenosis, stent thrombosis, ect.
Measured: At 1 month, 6 months and 2 years (according the actual duration of ticagrelor taken in patiens)
Incidence of bleeding events in the other observation times
During the other observation time, record the incidence of bleeding events after ticagrelor administration by telephone or outpatient clinic, including subcutaneous bleeding, gingival bleeding, gastrointestinal bleeding, intracranial hemorrhage, etc.
Measured: At 1 month, 6 months and 2 years (according the actual duration of ticagrelor taken in patiens)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2017
- Study start31 May 2017
- Primary completionOct 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for TicagrelorStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 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
- NCT03161002
- Sponsor's protocol ID
- 2016[1235]
- Status last verified
- Dec 2020
- First submitted
- 9 May 2017
- Last updated
- 22 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Xiang Q, Liu Z, Mu G, Xie Q, Zhang H, Zhou S, Wang Z, Guo N, Huang J, Jiang J, Li J, Yang G, Cui Y. Effect of Genetic Polymorphism Including NUP153 and SVEP1 on the Pharmacokinetics and Pharmacodynamics of Ticagrelor in Healthy Chinese Subjects. Clin Drug Investig. 2022 May;42(5):447-458. doi: 10.1007/s40261-022-01154-6. Epub 2022 Apr 30.
PubMed 35501592Yuan D, Shi X, Gao L, Wan G, Zhang H, Yang Y, Zhao Y, Sun D. Identification of Potential Biological Factors Affecting the Treatment of Ticagrelor After Percutaneous Coronary Intervention in the Chinese Population. Pharmgenomics Pers Med. 2022 Jan 20;15:29-43. doi: 10.2147/PGPM.S338287. eCollection 2022.
PubMed 35082514
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Biomarkers on Pharmacokinetics and Pharmacodynamics of Ticagrelor
- ClinicalTrials.gov ID
- NCT03161002
- Acronym / sponsor ID
- 2016[1235]
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Cui YiminUniversity, hospital or other
- Study start
- 31 May 2017 (actual)
- Primary completion
- Oct 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 19 May 2017 (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.
It is general that there are many factors for individual differences of drugs in clinical application, of which genetic factors accounted for more than 20%. Ticagrelor is a new-type receptor antagonist of P2Y12 and it is not affected by the influence of CYP2C19 polymorphism. With lack of predicted biomarkers, especially the research data of Chinese, it has the important significance in studying individual differences of ticagrelor in the antiplatelet efficacy and safety, through the pharmacogenomics research.
The aim of this study is to determine the polymorphism of drug metabolizing enzymes, drug transporters and drug target genes in Chinese population. By detecting the gene polymorphism, we intend to study the pharmacokinetic/ pharmacodynamics/ pharmacogenomics (PK-PD-PG) correlation of ticagrelor and provide scientific basis for accurate medication guide for people to use ticagrelor.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| wild genotype | – | Genetic: detection of genotypeThrough next generation sequencing, distinguish wild genotype of ticagrelor |
| mutant genotype | – | Genetic: detection of genotypeThrough next generation sequencing, distinguish mutant genotype of ticagrelor |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- (I)Chinese Healthy Volunteers：In accordance with the criteria of each bioequivalence trial of ticagrelor；150-200 cases (II)Chinese Patients：With diagnosis of acute coronary syndrome (ACS)，never received ticagrelor in a month and intend to take ticagrelor or have received ticagrelor for more than one week continuously；200 cases
Key inclusion criteria (9 listed)
- (I)Chinese Healthy Volunteers
- In accordance with the inclusion criteria for each bioequivalence trial of ticagrelor;
- Sign informed consent of the research;
- Complete to collect indexes of pharmacodynamics and pharmacogenomics in the cycle with control drug.
- (II)Chinese Patients
Key exclusion criteria (9 listed)
- (I)Chinese Healthy Volunteers
- In accordance with the exclusion criteria for each bioequivalence trial of ticagrelor;
- (II)Chinese Patients
- With history of immunodeficiency disease, including positive HIV index;
- Positive Hepatitis B surface antigen (HBsAg) and HCV index;
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 |
|---|---|---|
| detection of genotypedetection of genotype by next generation sequencing | Genetic | mutant genotype, wild genotype |
Primary outcome
Incidence of major adverse cardiac events (MACE)
Time frame: At 1 year
During the observation time, record the incidence of MACE after ticagrelor administration by telephone or outpatient clinic , including myocardial infarction, cardiac death, stent stenosis, stent thrombosis, ect.
Incidence of bleeding events
Time frame: At 1 year
During the observation time, record the incidence of bleeding events after ticagrelor administration by telephone or outpatient clinic, including subcutaneous bleeding, gingival bleeding, gastrointestinal bleeding, intracranial hemorrhage, etc.
8 secondary outcomes
genotype detected by next generation sequencing
Time frame: pre-dose of Ticagrelor
Level of platelet reactivity assessed by ADP aggregation rate
Time frame: At baseline, at 12 hours for Chinese healthy volunteers or at 48 hours for Chinese patients.
Level of platelet reactivity assessed by PRI
Time frame: At baseline, at 12 hours for Chinese healthy volunteers or at 48 hours for Chinese patients.
Expression level of miRNA
Time frame: At baseline, at 12 hours for Chinese healthy volunteers or at 48 hours for Chinese patients.
Expression level of proteomics
Time frame: At baseline, at 12 hours for Chinese healthy volunteers or at 48 hours for Chinese patients
Expression level of LncRNA
Time frame: At baseline, at 12 hours for Chinese healthy volunteers；at 48 hours for Chinese patients.
Incidence of MACEs in the other observation times
Time frame: At 1 month, 6 months and 2 years (according the actual duration of ticagrelor taken in patiens)
Incidence of bleeding events in the other observation times
Time frame: At 1 month, 6 months and 2 years (according the actual duration of ticagrelor taken in patiens)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2020.
- Derived from this study: PubMed 35501592Xiang Q, Liu Z, Mu G, Xie Q, Zhang H, Zhou S, Wang Z, Guo N, Huang J, Jiang J, Li J, Yang G, Cui Y. Effect of Genetic Polymorphism Including NUP153 and SVEP1 on the Pharmacokinetics and Pharmacodynamics of Ticagrelor in Healthy Chinese Subjects. Clin Drug Investig. 2022 May;42(5):447-458. doi: 10.1007/s40261-022-01154-6. Epub 2022 Apr 30.
- Derived from this study: PubMed 35082514Yuan D, Shi X, Gao L, Wan G, Zhang H, Yang Y, Zhao Y, Sun D. Identification of Potential Biological Factors Affecting the Treatment of Ticagrelor After Percutaneous Coronary Intervention in the Chinese Population. Pharmgenomics Pers Med. 2022 Jan 20;15:29-43. doi: 10.2147/PGPM.S338287. eCollection 2022.
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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.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ticagrelor and Pharmacokinetics, run by Cui Yimin at 7 sites 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 9 inclusion and 9 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 22 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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 Xiang, 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?
Incidence of major adverse cardiac events (MACE) (time frame: At 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03161002, which also lists 2 linked publications.
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 22 Dec 2020.