Rivaroxaban Post-Transradial Access for the Prevention of Radial Artery Occlusion (NCT03630055) | Clinical Trial Compass
TerminatedPhase 3
Rivaroxaban Post-Transradial Access for the Prevention of Radial Artery Occlusion
Stopped: Assessment for futility
United States, Canada930 participantsStarted 2018-10-03
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Willing and able to provide written informed consent
✓. Age ≥ 18 years
✓. 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
✕. Access or attempted access at a second site - including contralateral radial artery, brachial, or femoral artery or vein
✕. Planned staged procedure, CABG or noncardiac surgery within 30 days
✕. Contraindication or high risk of bleeding with anticoagulation
✕. bleeding requiring medical attention in the previous 6 months
✕. thrombocytopenia (platelets\<50 x 109/L)
✕. prior intracranial hemorrhage
What they're measuring
1
Primary efficacy outcome - rate of radial artery occlusion
Timeframe: 30 days
2
Primary safety outcome - International Society on Thrombosis and Haemostasis definition of major bleeding
Timeframe: 30 days
Trial details
NCT IDNCT03630055
SponsorOttawa Heart Institute Research Corporation