Precision Medicine Platform for Novel Oral Anticoagulants

NCT04056143 | Unknown DMC FDA Drug

• 2 other identifiers: KMUHIRB-G(I)-20180026108-2622-B-037-003 -CC1
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Anticoagulant Adverse Reaction

Keywords

Thromboembolism; Oral anticoagulants; Adverse events; Pharmacogenomics; Precision Medicine

Outcome Measures

Primary Outcomes (3)

• Number of major bleeding events during any NOAC treatment

  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.

  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.

• Number of minor bleeding events during any NOAC treatment

  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.

  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.

• Number of thromboembolism events during any NOAC treatment

  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.

  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.

Study Arms (4)

Dabigatran

Subjects who are receiving long-term Dabigatran for certain clinical conditions, and without any contraindication are enrolled for this cohort group.

Diagnostic Test: Pharmacogenomics

Rivaroxaban

Subjects who are receiving long-term Rivaroxaban for certain clinical conditions, and without any contraindication are enrolled for this cohort group.

Diagnostic Test: Pharmacogenomics

Apixaban

Subjects who are receiving long-term Apixaban for certain clinical conditions, and without any contraindication are enrolled for this cohort group.

Diagnostic Test: Pharmacogenomics

Edoxaban

Subjects who are receiving long-term Edoxaban for certain clinical conditions, and without any contraindication are enrolled for this cohort group.

Diagnostic Test: Pharmacogenomics

Interventions

Pharmacogenomics DIAGNOSTIC_TEST

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.

Also known as: Prothrombin time (PT), activated partial thromboplastin time (aPTT), Ecarin-based assay (for dabigatran), chromogenic anti-Xa assays (for rivaroxaban, apixaban, and edoxaban)

Apixaban; Dabigatran; Edoxaban; Rivaroxaban

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kaohsiung Medical University: lead

Study Sites (1)

Kaohsiung Medical University Hospital

Kaohsiung City, 807, Taiwan

RECRUITING

MeSH Terms

Conditions

Thromboembolism

Interventions

Pharmacogenomic Testing; Prothrombin Time; Partial Thromboplastin Time

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Genetic Testing; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Genetic Techniques; Genetic Services; Health Services; Health Care Facilities Workforce and Services; Diagnostic Services; Preventive Health Services; Blood Coagulation Tests; Hematologic Tests; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Hsiang-Chun Lee, MD, PhD

  Kaohsiung Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hsiang-Chun Lee, MD, PhD

CONTACT

886-7-3121101; hclee@kmu.edu.tw

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 30, 2019
• First Posted: August 14, 2019
• Study Start: January 2, 2019
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2022
• Last Updated: September 2, 2021

Record last verified: 2021-08

Locations

TW (1)