Circulatory System
Conditions
Interventions
no intervention we use the strandard treatment
Sponsors
hedi chaker hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Willing and able to provide written informed consent 2. Age = 18 years and <80 years 3. Diagnostic coronary angiography or percutaneous coronary intervention via the transradial approach
Exclusion criteria
Exclusion criteria: Presence of a palpable hematoma or clinical concern of hemostasis at the transradial access site 2. Access or attempted access at a second site - including contralateral radial artery, brachial, or femoral artery or vein 3. Planned staged procedure, CABG or noncardiac surgery within 30 days 4. Contraindication or high risk of bleeding with anticoagulation a. bleeding requiring medical attention in the previous 6 months b. thrombocytopenia (platelets<50 x 109/L) c. prior intracranial hemorrhage d. use of IIb/IIIa during percutaneous coronary intervention e. administration of thrombolytic therapy in the preceding 24 hours f. use of non-steroidal anti-inflammatory medications g. ischemic stroke or transient ischemic attack diagnosed in the last 3 months 5. Cardiogenic shock 6. Liver dysfunction (Child-Pugh class B or C) 8. Unexplained anemia with a Hemoglobin below 100 g/L 9. History of medication noncompliance or risk factor for noncompliance 10. Active malignancy 11. Allergy to Rivaroxaban 12. Another indication for curative anticoagulation (atrial fibrillation thromboembolic events, intra-cardiac thrombus) 13. CYP3A4 and P-glycoprotein inhibitor use (ex: Ticagrelor) 14. Life expectancy <30 days 15. Women capable of pregnancy not on birth control 16. Chronic kidney disease with creatinine clearance of less than 30mL/min ( calculated with cockroft formula) 17. History of anti-phosphopholipid antibody syndrome
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy outcome consists of the rate of radial artery occlusion at 30 days. This event will be assessed by a Doppler ultrasound assessment of the participant's radial artery in the wrist, at 30 days. The primary safety outcome according to consist of the incidence during 30 days of hemorrhagic events defined according to the Bleeding Academic Research Consortium (BARC) criteria and classification. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints were the following criteria: local complications on the puncture point (aneurysm, hematoma, arterial veinous fistula) BARC bleeding criteria at 30 days. | — |
Countries
Tunisia
Contacts
Public ContactSlim Abid
dr
Outcome results
None listed