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Trial record 31 of 1105 for:    pharmacogenomics OR pharmacogenetics

Precision Medicine Platform for Novel Oral Anticoagulants

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ClinicalTrials.gov Identifier: NCT04056143
Recruitment Status : Recruiting
First Posted : August 14, 2019
Last Update Posted : August 27, 2019
Sponsor:
Information provided by (Responsible Party):
Hsiang-Chun Lee, Kaohsiung Medical University

Brief Summary:
The anticoagulants have been developed with new generation for FDA-approved indications including treatment and prevention of venous, pulmonary, and systemic thromboembolism. While the prescription of new oral anticoagulants (NOAC) has increasingly and largely replaced warfarin in accordance of better efficacy and safety, there are still adverse effects, including incidental minor and major bleeding, and inefficacy in thrombosis prevention. The overarching goal of this study is to develop a Pharmacogenomics Platform that is specifically designed for NOACs, in order to optimize and personalize the prescription and to facilitate the precision medicine.

Condition or disease Intervention/treatment
Anticoagulant Adverse Reaction Other: Pharmacogenomics

Detailed Description:

Pharmaceutical companies have developed new oral anticoagulants (NOACs) to replace warfarin for prevention of systemic thrombo-embolization and embolic stroke in patients with atrial fibrillation or other thromboembolism diseases. The sale of NOACs has been increasing globally as the prevalence of atrial fibrillation increases in countries with aging population. Patients with high thromboembolism risk are also at high risk for major bleeding. The conservative strategy is not good for that more patients on reduced dose of NOACs had stroke. The clinical dilemma is how to justify the efficacy of NOACs in stroke prevention without encountering the incidental major bleeding from side effects. In order to solve this dilemma, the comprehensive evaluation of risk for thromboembolism, risk of bleeding, and genetic background on related to drug pharmacokinetics and response is essential. The primary goal of this project is to combine the clinical data and genetic information to develop a drug response evaluation platform to facilitate personalized and precision medicine for NOACs prescription.

Pharmacogenomics elucidates the drug response and side effect on the basis of individual genetic background. This proposed project will enroll clinical patients who have atrial fibrillation and indications for the prescription of NOACs. The information will be collected for clinical demographics, medical history of embolic stroke, thromboembolism events, any bleeding events, and concurrent use of other medicines. Peak level of NOAC in use, and post-drug coagulation test will be performed. The above data will be integrated for the pharmacogenomic analysis with multiple genes (CES1, ABCB1, SLCO1B1, CYP2C9*2, CYP2C9*3, VKORC, CYP3A4, MMP-9, ALOX5AP, MTHFR, FGB and eNOs). The single nucleotide polymorphism (SNPs) of gene clusters will be derived from this clinical study. These output results will be used to optimize the gene-array product that is specifically-designed for NOACs prescription.

The NOACs-specific gene-array for a precision prescription will be developed to help physicians to choose the right NOAC and the best dose for individualized patients. This tool will maximize thromboembolism prevention from the NOACs prescription along with the minimization of NOACs side effects. The product will be commercialized with great potential for the global market.


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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Development of Precision Medicine Platform for Pharmacogenomics of Novel Oral Anticoagulants (NOACs)
Actual Study Start Date : January 2, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Group/Cohort Intervention/treatment
Dabigatran
Subjects who are receiving long-term Dabigatran for certain clinical conditions, and without any contraindication are enrolled for this cohort group.
Other: Pharmacogenomics
Subjects enrolled in this study are providing blood samples for completing a set of laboratory testing and pharmacogenomic analyses. They are requested to comply a Pharmacist interview and complete of assisted questionnaires.
Other Name: Prothrombin time (PT), activated partial thromboplastin time (aPTT), Ecarin-based assay (for dabigatran), chromogenic anti-Xa assays (for rivaroxaban, apixaban, and edoxaban)

Rivaroxaban
Subjects who are receiving long-term Rivaroxaban for certain clinical conditions, and without any contraindication are enrolled for this cohort group.
Other: Pharmacogenomics
Subjects enrolled in this study are providing blood samples for completing a set of laboratory testing and pharmacogenomic analyses. They are requested to comply a Pharmacist interview and complete of assisted questionnaires.
Other Name: Prothrombin time (PT), activated partial thromboplastin time (aPTT), Ecarin-based assay (for dabigatran), chromogenic anti-Xa assays (for rivaroxaban, apixaban, and edoxaban)

Apixaban
Subjects who are receiving long-term Apixaban for certain clinical conditions, and without any contraindication are enrolled for this cohort group.
Other: Pharmacogenomics
Subjects enrolled in this study are providing blood samples for completing a set of laboratory testing and pharmacogenomic analyses. They are requested to comply a Pharmacist interview and complete of assisted questionnaires.
Other Name: Prothrombin time (PT), activated partial thromboplastin time (aPTT), Ecarin-based assay (for dabigatran), chromogenic anti-Xa assays (for rivaroxaban, apixaban, and edoxaban)

Edoxaban
Subjects who are receiving long-term Edoxaban for certain clinical conditions, and without any contraindication are enrolled for this cohort group.
Other: Pharmacogenomics
Subjects enrolled in this study are providing blood samples for completing a set of laboratory testing and pharmacogenomic analyses. They are requested to comply a Pharmacist interview and complete of assisted questionnaires.
Other Name: Prothrombin time (PT), activated partial thromboplastin time (aPTT), Ecarin-based assay (for dabigatran), chromogenic anti-Xa assays (for rivaroxaban, apixaban, and edoxaban)




Primary Outcome Measures :
  1. Number of major bleeding events during any NOAC treatment [ Time Frame: From date of enrollment until the date of first major bleeding events of any type or date of death, whichever came first, assessed up to 36 months. ]
    Any gastrointestinal, retroperitoneal, urinary tract, abnormal uterine bleeding, intracranial, intra-ocular or intra-spinal bleeding events that are noted in medical records or examination reports, or demonstrated by images studies including a computer tomography scan or a magnetic resonance imaging, or a sonography or an ophthalmoscope; or bleeding requiring surgery; or transfusion of ≥ 2 units (i.e. ≥ 500 mL) of packed red blood cells) or associated with a decrease in hemoglobin of ≥ 2.0 g/L episodes.

  2. Number of minor bleeding events during any NOAC treatment [ Time Frame: From date of enrollment until the date of first major bleeding events of any type or date of death, whichever came first, assessed up to 36 months. ]
    Any gastrointestinal, urinary tract, abnormal uterine, soft tissue, skin, conjunctival, nasopharyngeal, oral cavity bleeding events that are noted in medical records or examination reports, or demonstrated by images studies including an endoscopic examination, or a sonography or an ophthalmoscope; or requirement of blood transfusion of < 2 units (i.e. less than 500 mL) of packed red blood cells or associated with a decrease in hemoglobin of < 2.0 g/L episodes.

  3. Number of thromboembolism events during any NOAC treatment [ Time Frame: From date of enrollment until the date of first thromboembolism events of any type or date of death, whichever came first, assessed up to 36 months. ]
    Any clinical evident events of venous, pulmonary, or systemic thromboembolism that are noted in medical records or examination records, or demonstrated by images of an angiography, or a sonography, or a computer tomography scan, or an isotope phlebography.



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who have one of the indications to use long-term anticoagulants, including atrial fibrillation, deep venous thrombosis, and pulmonary embolism.
Criteria

Inclusion Criteria:

  • Long-term indication for use of dabigatran
  • Long-term indication for use of rivaroxaban
  • Long-term indication for use of apixaban
  • Long-term indication for use of edoxaban

Exclusion Criteria:

  • Any contraindication for use of anticoagulants
  • Prisoners
  • pregnancy
  • mental disorders
  • history of any mechanical or prosthetic valve replacement
  • hemodialysis or other renal replacement therapy
  • congenital coagulation abnormalities
  • autoimmune diseases

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): NCT04056143


Contacts
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Contact: Hsiang-Chun Lee, MD, PhD 886-7-3121101 ext 2293 hclee@kmu.edu.tw

Locations
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Taiwan
Kaohsiung Medical University Hospital Recruiting
Kaohsiung, Taiwan, 807
Contact: Hsiang-Chun Lee, MD, PhD    886-7-3121101 ext 2293    hclee@kmu.edu.tw   
Sponsors and Collaborators
Kaohsiung Medical University
Investigators
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Principal Investigator: Hsiang-Chun Lee, MD, PhD Kaohsiung Medical University

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Responsible Party: Hsiang-Chun Lee, Assistant Professor, Kaohsiung Medical University
ClinicalTrials.gov Identifier: NCT04056143     History of Changes
Other Study ID Numbers: KMUHIRB-G(I)-20180026
108-2622-B-037-003 -CC1 ( Other Grant/Funding Number: Taiwan Ministry of Science and Technology )
First Posted: August 14, 2019    Key Record Dates
Last Update Posted: August 27, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Keywords provided by Hsiang-Chun Lee, Kaohsiung Medical University:
Thromboembolism
Oral anticoagulants
Adverse events
Pharmacogenomics
Precision Medicine
Additional relevant MeSH terms:
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Rivaroxaban
Apixaban
Edoxaban
Dabigatran
Anticoagulants
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action