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Recruiting Phase 3 NCT03630055

Rivaroxaban Post-Transradial Access for the Prevention of Radial Artery Occlusion

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Trial Parameters

Condition Radial Artery Occlusion
Sponsor Ottawa Heart Institute Research Corporation
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 1,800
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2018-10-03
Completion 2025-12-30
Interventions
Rivaroxaban 15 MG Oral Tablet [Xarelto]

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Brief Summary

Coronary angiography is performed to evaluate for obstructive coronary artery disease. This is commonly performed via the transfemoral or transradial approach with the latter increasing in frequency. One of the most common complications of transradial access is radial artery occlusion occurring in \~5% of patients which prohibits the use of the radial artery in the future. There is evidence to support the use of intraprocedural anticoagulation to mitigate the risk of radial artery occlusion however the role of post-procedural anticoagulation has not been previously evaluated. Rivaroxaban is a direct oral anticoagulant (DOAC) with a safety profile superior to that of vitamin K antagonists. Given the safety profile, ease of use, and feasibility of DOAC therapy, our study will endeavor to evaluate the use of rivaroxaban 15mg orally once daily for 7 days after transradial access and the impact this has on the rate of radial artery occlusion.

Eligibility Criteria

Inclusion Criteria: 1. Willing and able to provide written informed consent 2. Age ≥ 18 years 3. Diagnostic coronary angiography or percutaneous coronary intervention via the transradial approach Exclusion Criteria: 1. 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 1. bleeding requiring medical attention in the previous 6 months 2. thrombocytopenia (platelets\<50 x 109/L) 3. prior intracranial hemorrhage 4. use of IIb/IIIa during percutaneous coronary intervention 5. administration of thrombolytic therapy in the preceding 24 hours 6. use of non-steroidal anti-inflammatory medications 7. ischemic stroke or transient ischemic attack diagnosed in the last 3 months 5. Cardiogenic shoc

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