RIVARAD study

Phase 1

Completed

• Conditions: Circulatory System

• Registration Number: PACTR202110633346282
• Lead Sponsor: hedi chaker hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-17
• Last Update Posted: 2023-05-29

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 512

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified