Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2025-12-24 @ 9:07 PM
NCT ID:
NCT03124004
Eligibility Criteria:
Direct Oral Anticoagulant
Inclusion Criteria:
1. Male and female patients at 20 or more years of age.
2. Healthy patients (≤ American Society of Anesthesiologists 3).
3. Regular oral anticoagulant therapy assumed from at least 3 months with the following molecula: Dabigatran (PRADAXA), Rivaroxaban (XARELTO), Apixaban (ELIQUIS), Edoxaban (LIXIANA).
4. Indication for extraction of a single tooth.
5. No other contraindications for tooth extraction.
6. Accepted platelet count within 7 days prior to the procedure has to be \> 50000 mg/dl.
7. Signed informed consent.
Exclusion Criteria:
1. Smoke \> 10 cigarettes per day.
2. Assumption of any antiplatelet medication.
3. Assumption of Heparin medication.
4. Assumption of oral anticoagulant medications (Warfarin, Coumadin).
5. Wash-out period after antiplatelet or Heparin medication at least 15 days.
6. Assumption of food or drugs that may alter direct oral anticoagulant blood values.
7. Uncontrolled Hypertension.
8. Uncontrolled Diabetes
9. Chronic Hepatitis and/or reduction of hepatic function
10. Coagulopathy (in excess of defect)
11. Anamnestically known intolerance to one of the drugs applied or to their ingredients or to drugs of similar chemical structure.
12. Head and neck radiotherapy (previous 10 years).
13. Chemotherapy (previous 2 years).
14. Participation of the patient in another clinical trial within the last four weeks before enrollment in this trial.
15. Incapability of assessing essence and possible consequences of the trial (e.g. alcoholism).
16. Pregnant or breastfeeding women.
17. Evidence suggesting that the patient is not likely to follow the study protocol (e.g. lack of compliance).
Oral Anticoagulant Therapy
Inclusion Criteria:
1. Male and female patients at 20 or more years of age.
2. General health status (\< American society of anesthesiologist a 3).
3. Regular oral anticoagulant therapy assumed from at least 3 months with the following molecula: Warfarin (COUMADIN), acenocoumarol (SINTROM).
4. Indication for extraction of a single tooth.
5. No contraindications for tooth extraction.
6. Accepted platelet count within 7 days prior to the procedure has to be \> 50000 mg/dl.
7. International Normalized Ratio measured within 7 days prior to the procedure should between 2.0 and 3.0.
8. No diet changes within the week before blood sampling (avoiding interacting food)
9. Signed informed consent.
Exclusion Criteria:
1. Smoke \> 10 cigarettes per day.
2. Assumption of any antiplatelet medication.
3. Assumption of any Heparin medication.
4. Assumption of any direct oral anticoagulant medication.
5. Uncontrolled Hypertension.
6. Uncontrolled Diabetes.
7. Chronic Hepatitis and/or reduction of hepatic function
8. Coagulopathy (in excess of defect)
9. Wash-out period after antiplatelet or Heparin medication at least 15 days.
10. Anamnestically known intolerance to one of the drugs applied or to their ingredients or to drugs of similar chemical structure.
11. Assumption of food or drugs that may alter oral anticoagulant blood values.
12. Head and neck radiotherapy (previous 10 years).
13. Chemotherapy (previous 10 years).
14. Participation of the patient in another clinical trial within the last four weeks before enrollment in this trial.
15. Incapability of assessing essence and possible consequences of the trial (e.g. alcoholism).
16. Pregnant or breastfeeding women.
17. Evidence suggesting that the patient is not likely to follow the study protocol (e.g. lack of compliance).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT03124004
Study Brief:
Protocol Section:
NCT03124004