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A Research in Pharmacogenomics and Accurate Medication of New Antiplatelet Drug Ticagrelor

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ClinicalTrials.gov Identifier: NCT03161002
Recruitment Status : Recruiting
First Posted : May 19, 2017
Last Update Posted : May 16, 2018
Sponsor:
Information provided by (Responsible Party):
Cui Yimin, Peking University First Hospital

Brief 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. 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.


Condition or disease Intervention/treatment
Ticagrelor Pharmacokinetics Pharmacodynamics Pharmacogenomics Accurate Medication Genetic: detection of genotype

Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Research in Pharmacogenomics and Accurate Medication of New Antiplatelet Drug Ticagrelor
Actual Study Start Date : May 31, 2017
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners
Drug Information available for: Ticagrelor

Group/Cohort Intervention/treatment
wild genotype
Through next generation sequencing, distinguish wild genotype of ticagrelor
Genetic: detection of genotype
detection of genotype by next generation sequencing

mutant genotype
Through next generation sequencing, distinguish mutant genotype of ticagrelor
Genetic: detection of genotype
detection of genotype by next generation sequencing




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. genotype detected by next generation sequencing [ Time Frame: pre-dose of Ticagrelor ]
    Collect blood specimen before ticagrelor administration, then detect genotype of Ticagrelor by next generation sequencing.

  2. 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. ]
    Before and after ticagrelor administration, record the ADP aggregation rate detected by Light Transmittance Aggregometry(LTA).

  3. 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. ]
    Before and after ticagrelor administration, record PRI detected by VerifyNow System.

  4. Expression level of miRNA [ Time Frame: At baseline, at 12 hours for Chinese healthy volunteers or at 48 hours for Chinese patients. ]
    Before and after ticagrelor administration, detect the expression level of miRNA about pharmacodynamics.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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
Criteria

Inclusion Criteria:

(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;
  • 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.

Exclusion Criteria:

(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;
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03161002


Contacts
Contact: Qian Xiang, Ph.D +86 010 66110802 xiangqz@126.com

Locations
China, Anhui
Anhui Provincial Hospital(The First Affiliated Hospital Of USTC) Recruiting
Hefei, Anhui, China, 230001
Contact: Zhaoyi Yang, PhD    +86-0551-62283379-800    young2382@163.com   
The First Affiliated Hospital of Anhui Medical University Not yet recruiting
Hefei, Anhui, China, 230001
Contact: Yan Huang, MS    +86-15056922343    hyayd123@126.com   
China, Beijing
Peking University First Hospital Recruiting
Beijing, Beijing, China, 100034
Contact: Qian Xiang, Ph.D    +86 010 66110802    xiangqz@126.com   
China, Henan
The 7th People's Hospital Of Zhengzhou Recruiting
Zhengzhou, Henan, China, 450006
Contact: Dongdong Yuan, MS    +86-0371-89905878    44676878@qq.com   
China, Jiangxi
The Second Affiliated Of Nanchang University Enrolling by invitation
Nanchang, Jiangxi, China, 330006
Sponsors and Collaborators
Cui Yimin

Responsible Party: Cui Yimin, Director of pharmacy,M.D & Ph.D, Peking University First Hospital
ClinicalTrials.gov Identifier: NCT03161002     History of Changes
Other Study ID Numbers: 2016[1235]
First Posted: May 19, 2017    Key Record Dates
Last Update Posted: May 16, 2018
Last Verified: May 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Ticagrelor
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs