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Effect of TXA Oral Sol 5% in Patients Treated With DOACs or VKA and Undergoing a Single or Multiple Tooth Extraction

Sponsor
Hyloris Developments (Industry)
Overall Status
Recruiting
CT.gov ID
NCT06143787
Collaborator
(none)
280
Enrollment
19
Locations
2
Arms
7.7
Anticipated Duration (Months)
14.7
Patients Per Site
1.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the effect of Tranexamic Acid Oral Solution 5% in patients treated with direct oral anticoagulants or vitamin K antagonists and undergoing a single or multiple tooth extraction.

Condition or Disease Intervention/Treatment Phase
  • Drug: Tranexamic acid
 Phase 3

Detailed Description

The purpose of this study is to compare the efficacy, acceptability, and safety of Tranexamic Acid Oral Solution 5% with placebo in the prevention of clinically relevant bleeding events in subjects treated with direct oral anticoagulants or vitamin K antagonists and undergoing a single or multiple tooth extraction.

A total of approximately 280 subjects will be randomized in two equal treatment groups (approximately 140 subjects per group) to receive Tranexamic Acid Oral Solution 5% or placebo solution for 7 days. Following screening, eligible subjects can be randomized within 14 days when all eligibility criteria are confirmed. Randomized subjects will undergo tooth extraction(s) and treatment period. The treatment period ends at Visit 5 followed by the follow-up period. The maximal study duration is about 4 weeks.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
280 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
randomized, double-blind, multi-center, placebo-controlled, parallel-grouprandomized, double-blind, multi-center, placebo-controlled, parallel-group
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
double-blind
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-blind, Multi-center, Placebo-controlled, Parallel-group Phase 3 Study to Compare the Efficacy, Acceptability, and Safety of Tranexamic Acid Oral Solution 5% With Placebo in the Prevention of Clinically Relevant Bleeding Events in Subjects Treated With Direct Oral Anticoagulants or Vitamin K Antagonists and Undergoing a Single or Multiple Tooth Extraction.
Actual Study Start Date :
Nov 7, 2023
Anticipated Primary Completion Date :
Jun 27, 2024
Anticipated Study Completion Date :
Jun 27, 2024

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Treatment (T1)

Standard hemostatic measures + Placebo matching with Tranexamic Acid Oral Solution 5%

Drug: Tranexamic acid
7 days Oral rinsing following tooth extraction
Other Names:
  • Tranexamic Acid Oral Solution 5%

    		•
    Experimental: Treatment (T2)

    Standard hemostatic measures + Tranexamic Acid Oral Solution 5%

    Drug: Tranexamic acid
    7 days Oral rinsing following tooth extraction
    Other Names:
  • Tranexamic Acid Oral Solution 5%

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of clinically relevant postoperative oral bleeding episodes [7 days]

      Number of clinically relevant postoperative oral bleeding episodes (including clinically relevant orofacial hematomas)

    Secondary Outcome Measures

    1. Number of not clinically relevant postoperative oral bleeding episodes [7 days]

      Number of not clinically relevant postoperative oral bleeding episodes (including not clinically relevant orofacial hematomas)

    2. Number of delayed postoperative oral bleeding episodes [7 days]

      Number of delayed postoperative oral bleeding episodes, both clinically relevant and not clinically relevant, in all subjects.

    3. Number of early postoperative oral bleeding episodes [7 days]

      Number of early (less than 24 h post-tooth extraction) postoperative oral bleeding episodes, both clinically relevant and not clinically relevant, in all subjects

    4. Perioperative and immediate post-operative duration [7 days]

      Perioperative and immediate post-operative (procedural bleeding) duration (min, all types of oral bleeding).

    5. Medication Acceptability Questionnaire (MAQ) completed [7 days]

      Medication Acceptability Questionnaire (MAQ) for Tranexamic Acid Oral Solution 5% use completed in all subjects

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Provide their signed study informed consent to participate.

    2. Male or female ≥ 18 years of age at screening.

    3. Body mass index (BMI) between 18.5 kg/m2 and 35 kg/m2, inclusively and body weight ≥ 50 kg.

    4. Treated regularly for ≥ 3 months with direct oral anticoagu19lant (e.g., edoxaban, apixaban, rivaroxaban, dabigatran) or vitamin K antagonists (e.g., acenocoumarol, warfarin, etc.).

    5. Subjects on VKAs can be enrolled if the subject's International Normalized Ratio (INR) at screening, but not more than 5 days before the dental extraction procedure is within the range of 2.0-3.5.

    6. Subjects taking VKAs or DOACs can be enrolled if these are prescribed and used according to the approved product label.

    7. Scheduled to undergo a single or multiple tooth extraction.

    8. Considered as reasonably healthy to follow the study procedures as documented by the medical history, physical examination, and vital sign assessments.

    9. Subjects with a platelet count of 100,000-500,000 (inclusive) platelets per microliter.

    10. Subject with hemoglobin ≥ 12.0 g/dL (male) or ≥ 11.0 g/dL (female).

    11. Willing to avoid alcohol consumption for the duration of the study.

    12. Willing and able to adhere to the study assessment schedule and other protocol requirements as evidenced by a written informed consent.

    13. Negative pregnancy test in females of childbearing potential at Screening and Day 1 visit.

    14. Women must be post-menopausal (defined as no menses for 12 months without an alternative medical cause), surgically sterile, or willing to use highly effective method of birth control which is defined as those which result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly (refer to Table 4 for further information on acceptable and unacceptable birth control methods). The Investigator is responsible for determining whether the subject has adequate birth control for study participation.

    Exclusion Criteria:

    1. Any coagulation disorders requiring TXA.

    2. Requires tooth extraction for orthodontic reason.

    3. History of severe allergy or allergic reactions or hypersensitivity to the study drug or any component of its formulations or related drugs or heparin

    4. Subjects with type II, III and IV periodontitis (as per American Dental Association Classification) (see Appendix 1).

    5. History of subarachnoid hemorrhage.

    6. Active intravascular clotting (defined as a history of thrombosis within the past 3 months).

    7. Blood in the urine (macroscopic hematuria) at Screening.

    8. Renal function test result of estimated glomerular filtration rate ≤ 15 mL/min/1.73 m² at Screening.

    9. Any ongoing or planned dual anti-platelet treatment for the duration of subject's participation in the study (any 2 of the following: aspirin, dipyridamole, or any thienopyridine, i.e., clopidogrel, prasugrel, ticlopidine, ticagrelor). However, subjects receiving a very low dose aspirin (≤ 160 mg) may be enrolled.

    10. Any ongoing or planned oncological treatment for the duration of subject's participation in the study.

    11. Any immunocompromising condition.

    12. Use of any recreational drugs or history of drug addiction.

    13. Positive alcohol breath test at Screening and Day 1.

    14. Participating in any other clinical study or has received treatment with any investigational drug or device within 3 months prior to screening.

    15. History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of the investigational drug, might affect interpretation of the results of the study, or renders the subject at high risk for treatment complications (including but not limited to diseases such as uncontrolled diabetes, any haemato-oncological condition [e.g., leukemia], any congenital hematological condition [e.g., hemophilia]).

    16. Severe uncontrolled arterial hypertension, e.g., > 200 mmHg systolic or > 110 mmHg diastolic blood pressure at two consecutive readings.

    17. Subjects who are found positive to human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) serological tests.

    18. Use of hormonal methods of birth control that increase the risk of thrombosis (e.g., estrogen-containing contraceptives). Refer to Table 4 in protocol Section 8.2.11 for further information on acceptable and unacceptable birth control methods.

    19. Women with intended pregnancy or breast-feeding.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Loma Linda University School of Dentistry Loma Linda California United States 92350
    2 JBR Clinical Research (CenExel) Millcreek Utah United States 84107
    3 Roseman University of Health Sciences, College of Dental Medicine South Jordan Utah United States 84107
    4 Hyloris Development Liège Belgium 4000
    5 Clinical Hospital Center Rijeka, Dental clinic Rijeka Croatia 51000
    6 University Hospital of Split Department of Oral surgery Split Croatia 21000
    7 Dental Clinic Zagreb Zagreb Croatia 10000
    8 University hospital Dubrava Department of oral surgery Zagreb Croatia 10000
    9 Semmelweis Egyetem, Fogorvostudományi Kar, Arc-Állcsont-Szájsebészeti És Fogászati Klinika Budapest Hungary 1085
    10 SZTE SZAKK Arc-, Állcsont- és Szájsebészeti Klinika Szeged Hungary 6722
    11 Arc-, Állcsont-, Szájsebészeti Osztály Veszprém Hungary 8200
    12 "Dr. Carol Davila" Central Military Emergency University Hospital Bucharest Bucuresti Romania 010825
    13 Trident Clinic Bucuresti Romania 050533
    14 SCJU Craiova Craiova Romania 200642
    15 Medicine and Healthcare Science Faculty of Barcelona University (Campus Bellvitge Barcelona Spain 08907
    16 Puerta del Mar University Hospital Cadiz Spain 11009
    17 Jerez Center Health Center Jerez de la Frontera Spain 11403
    18 Hospital Universitario La Paz Madrid Spain 28046
    19 Institute of Biotechnology of Seville (IBIS) Sevilla Spain 41009

    Sponsors and Collaborators

    • Hyloris Developments

    Investigators

    • Principal Investigator: Todd Bertoch, Dr., JBR Clinical Research (CenExcel)

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hyloris Developments
    ClinicalTrials.gov Identifier:
    NCT06143787
    Other Study ID Numbers:
    • HYL-P004-003
    • 2023-503719-13-00
    First Posted:
    Nov 22, 2023
    Last Update Posted:
    Nov 22, 2023
    Last Verified:
    Nov 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Hyloris Developments
    bleeding teeth
    Tranexamic Acid
    Oral Solution
    Tranexamic Acid Oral Solution 5%
    Additional relevant MeSH terms:
    Hemorrhage
    Tranexamic Acid

    Study Results

    No Results Posted as of Nov 22, 2023