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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.
EU CTIS ID: 2023-503719-13-00
What this study is testing
To assess and compare the efficacy of Tranexamic Acid Oral Solution 5% with placebo to reduce clinically relevant postoperative oral bleeding (including clinically relevant orofacial hematomas) in subjects treated with direct oral anticoagulants (DOACs) or vitamin K antagonists (VKAs) and following a single or multiple tooth extraction(s) in all subjects.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Provide their signed study informed consent to participate.
- Subject with hemoglobin ≥ 12.0 g/dL (male) or ≥ 11.0 g/dL (female).
- Willing to avoid alcohol consumption for the duration of the study
- Willing and able to adhere to the study assessment schedule and other protocol requirements as evidenced by a written informed consent
- Negative pregnancy test in females of childbearing potential at Screening and Day 1 visit.
- 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
You likely can't join if
- Any coagulation disorders requiring TXA.
- 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.
- Women with intended pregnancy or breast-feeding
- Any ongoing or planned oncological treatment for the duration of subject`s participation in the study
- Any immunocompromising condition.
- Use of any recreational drugs or history of drug addiction.
See the full eligibility criteria
Who can join
- Provide their signed study informed consent to participate.
- Subject with hemoglobin ≥ 12.0 g/dL (male) or ≥ 11.0 g/dL (female).
- Willing to avoid alcohol consumption for the duration of the study
- Willing and able to adhere to the study assessment schedule and other protocol requirements as evidenced by a written informed consent
- Negative pregnancy test in females of childbearing potential at Screening and Day 1 visit.
- 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
- Male or female ≥ 18 years of age at screening.
- Body mass index (BMI) between 18.5 kg/m2 and 35 kg/m2, inclusively and body weight ≥ 50 kg.
- Treated regularly for ≥ 3 months with direct oral anticoagulant (e.g., edoxaban, apixaban, rivaroxaban, dabigatran) or vitamin K antagonists (e.g., acenocoumarol, warfarin, etc.).
- 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.
- Subjects taking VKAs or DOACs can be enrolled if these are prescribed and used according to the approved product label
- Scheduled to undergo a single or multiple tooth extraction
- Considered as reasonably healthy to follow the study procedures as documented by the medical history, physical examination, and vital sign assessments
- Subjects with a platelet count of 100,000-500,000 (inclusive) platelets per microliter
What rules you out
- Any coagulation disorders requiring TXA.
- 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.
- Women with intended pregnancy or breast-feeding
- Any ongoing or planned oncological treatment for the duration of subject`s participation in the study
- Any immunocompromising condition.
- Use of any recreational drugs or history of drug addiction.
- Positive alcohol breath test at Screening and Day 1.
- Participating in any other clinical study or has received treatment with any investigational drug or device within 3 months prior to screening.
- 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]).
- Severe uncontrolled arterial hypertension, e.g., > 200 mmHg systolic or > 110 mmHg diastolic blood pressure at two consecutive readings
- Subjects who are found positive to human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) serological tests.
- 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.
- Women with intended pregnancy or breast-feeding
- Planned soft (other than extraction site) or hard oral tissue biopsy on the day of the surgery
- Subjects who are evaluated to have a negative risk-benefit ratio to participate in this study (e.g., high risk of severe bleeding).
- Wisdom teeth extraction of Class II-III /Position B-C according to the Pell and Gregory classification (see Appendix 6).
- History of severe allergy or allergic reactions or hypersensitivity to the study drug or any component of its formulations or related drugs or heparin
- Subjects with type II, III and IV periodontitis (as per American Dental Association Classification) (see Appendix 1).
- History of subarachnoid hemorrhage.
- Active intravascular clotting (defined as a history of thrombosis within the past 3 months).
- Blood in the urine (macroscopic hematuria) at Screening.
- Renal function test result of estimated glomerular filtration rate ≤ 15 mL/min/1.73 m² at Screening.
The study team makes the final eligibility decision.
Where it's taking place
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.