Rivaroxaban Post-Transradial Access for the Prevention of Radial Artery Occlusion (CAPITAL-RAPTOR)
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|ClinicalTrials.gov Identifier: NCT03630055|
Recruitment Status : Recruiting
First Posted : August 14, 2018
Last Update Posted : October 16, 2018
|Condition or disease||Intervention/treatment||Phase|
|Radial Artery Occlusion||Drug: Rivaroxaban 15 MG Oral Tablet [Xarelto]||Phase 3|
Assessment of the coronary artery anatomy is commonly performed by coronary angiography (CA), which is the gold standard for evaluation of obstructive coronary artery disease (CAD). Coronary revascularization, opening of obstructed vessels, is most commonly performed by percutaneous coronary intervention (PCI) in patients with obstructive CAD. Traditionally, PCI is performed with implantation of one or more permanent metallic stents which act as a scaffold for arterial recoil and, in the case of drug eluting stents (DES), provide a platform for delivery of anti-proliferative agents. The transradial access (TRA) has rapidly emerged as the preferred vascular access site for CA and PCI with more than 50% of all coronary angiograms being performed via this approach.
There are several advantages to TRA for angiography including rapid hemostasis, early ambulation after the procedure thereby improving patient comfort and experience, and a decrease in the length of hospital stay. There is also a reported reduction in all-cause mortality, major adverse cardiovascular events, major bleeding, and vascular complications with TRA as compared to transfemoral access. However, radial artery occlusion (RAO) remains an important complication of this procedure as it precludes the reuse of this artery for future transradial approaches as well as the use of the vessel as a conduit for coronary artery bypass grafting.
Reports of RAO post-TRA has varied in the literature from ~4-10% in observational and randomized trials. In the largest systematic review published to date, the overall rate of RAO was 5.2% amongst the 46,631 subjects across 92 studies between 1989 and 2016. This systematic review also noted that the rate of early (i.e. <7 days) vs. late (i.e. >7 days) RAO was significantly higher which is suggestive of late recanalization in some patients. The factors which affect recanalization are not clear however standard of care involves administration of heparin during the procedure and patent hemostasis following the procedure. Patent hemostasis is performed by applying a delicate balance of pressure to prevent bleeding but not to the point of completely occlude the blood vessel and cessation of blood flow distally.
Numerous trials have explored the role of anticoagulation during angiography to reduce RAO and a recently published systematic review and meta-analysis demonstrated more intensive anticoagulation is protective. Indeed, this remains an active area of research with numerous ongoing trials evaluating the effect of intensive or higher dose anticoagulation during the procedure for prevention of RAO. Additionally, there were higher rates of RAO with diagnostic angiography as opposed to PCI purportedly as the latter involves higher doses of anticoagulation.
Direct oral anticoagulant (DOAC) therapy has provided a safer alternative with an improved bleeding profile over vitamin K antagonist anticoagulation therapy. The use of DOACs in cardiovascular medicine ranges from various conditions including stroke prevention in atrial fibrillation7-12 to venous thromboembolism13-16 to stable cardiovascular disease.
While intraprocedural anticoagulation has been studied extensively, a course of anticoagulation therapy post-TRA has not been studied. 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 RAO. Should this study prove to be positive, this could impact our routine standard of care with respect to having a strategy which could reduce the rate of this complication thereby preserving the radial artery for future access and/or as a conduit for coronary artery bypass grafting.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1826 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Eligible patients will undergo a 1:1 randomization using a computer-generated randomization sequence to either receive a direct oral anticoagulant (i.e. rivaroxaban 15mg oral daily) for 7 days or to the standard of care arm (i.e. no rivaroxaban)|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Rivaroxaban Post-Transradial Access for the Prevention of Radial Artery Occlusion|
|Actual Study Start Date :||October 3, 2018|
|Estimated Primary Completion Date :||September 30, 2020|
|Estimated Study Completion Date :||October 30, 2020|
Participants will receive rivaroxaban 15mg tablet to be taken orally once daily for 7 days. Follow up will be within 30 days where participants will undergo a Doppler ultrasound to assess for radial artery patency/occlusion.
Drug: Rivaroxaban 15 MG Oral Tablet [Xarelto]
Patients will receive rivaroxaban 15mg orally daily for 7 days following transradial access.
Other Name: Xarelto
No Intervention: Standard of Care
Participants will not receive any anticoagulation. Follow up will be within 30 days where participants will undergo a Doppler ultrasound to assess for radial artery patency/occlusion.
- Primary efficacy outcome - rate of radial artery occlusion [ Time Frame: 30 days ]Presence of radial artery occlusion at 30 days post-transradial access as determined by Doppler ultrasound assessment of the participant's radial artery in the wrist.
- Primary safety outcome - International Society on Thrombosis and Haemostasis definition of major bleeding [ Time Frame: 30 days ]Bleeding as defined by the International Society on Thrombosis and Haemostasis at 30 days.
- All cause mortality [ Time Frame: 30 days ]Death from any cause as determined by the treating physician
- Stroke (ischemic or uncertain) [ Time Frame: 30 days ]Stroke (ischemic or uncertain) as defined by a treating neurologist
- Stroke (hemorrhagic) [ Time Frame: 30 days ]Stroke (hemorrhagic) as defined by a treating neurologist
- Fatal bleeding [ Time Frame: 30 days ]Bleeding resulting in death as defined by treating physician
- Symptomatic bleeding in a critical area or organ [ Time Frame: 30 days ]Intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial bleeding or intramuscular bleeding with compartment syndrome
- Bleeding requiring medical attention [ Time Frame: 30 days ]Any bleeding that requires participant to seek medical attention
- GUSTO bleeding criteria [ Time Frame: 30 days ]Bleeding as defined by the Global Utilization Of Streptokinase And Tpa For Occluded Arteries (GUSTO) criteria
- TIMI bleeding criteria [ Time Frame: 30 days ]Bleeding as defined by the Thrombolysis in Myocardial Infarction (TIMI) criteria
- BARC bleeding criteria [ Time Frame: 30 days ]Bleeding as defined by the Bleeding Academic Research Consortium (BARC) criteria
- Myocardial infarction [ Time Frame: 30 days ]Myocardial infarction as defined by the third universal definition of myocardial infarction.
- Stent thrombosis [ Time Frame: 30 days ]Stent thrombosis as determined by the academic research consortium criteria.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03630055
|Contact: Benjamin Hibbert, MD PhDfirstname.lastname@example.org|
|Contact: Pietro Di Santo, MDemail@example.com|
|University of Ottawa Heart Institute||Recruiting|
|Ottawa, Ontario, Canada, K1Y4W7|
|Contact: Benjamin Hibbert, MD PhD|