Rivaroxaban for Radial Artery Occlusion

Overseen By Sarah R Devamani

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Mayo Clinic

Must not be taking: NSAIDs, Glycoprotein IIb/IIIa inhibitors

Disqualifiers: Pregnancy, Liver dysfunction, Active malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 1 week

700 Participants Needed

Trial Summary

What is the purpose of this trial?

Transradial access (TRA) is the preferred vascular access site for invasive coronary angiography. TRA is limited by blockage of the radial artery post-procedurally, preventing future use of TRA. This is referred to as radial artery occlusion (RAO) and occurs in \~5% of cases. While intraprocedural anticoagulation has been studied extensively to mitigate this complication, oral anticoagulation post-TRA has not. The investigators will assess the impact of a one-week course of rivaroxaban post-TRA to reduce the rate of ultrasound-defined RAO at 30 days.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are using certain medications like strong CYP3A4 and P-glycoprotein inhibitors, or regular non-steroidal anti-inflammatory drugs (except low-dose Aspirin), you may not be eligible to participate.

What data supports the effectiveness of the drug Rivaroxaban for preventing radial artery occlusion?

Research shows that using Rivaroxaban for a short time after coronary procedures can help prevent radial artery occlusion, which is a common complication when accessing the heart through the wrist. ^{1 2 3 4 5}

Is Rivaroxaban generally safe for humans?

Rivaroxaban is generally considered safe for humans, with studies showing it has a favorable safety profile, particularly with a lower risk of fatal bleeding compared to some other blood thinners. However, in high-risk patients with antiphospholipid syndrome, it was associated with more adverse events compared to warfarin. ^{1 6 7 8 9}

How does the drug rivaroxaban differ from other treatments for radial artery occlusion?

Rivaroxaban is unique because it is an oral anticoagulant that directly inhibits Factor Xa, a key protein in the blood clotting process, which helps prevent blood clots more effectively than some traditional treatments. Unlike other anticoagulants that may require injections, rivaroxaban is taken orally, making it more convenient for patients. ^{10 11 12 13 14}

Research Team

Trevor J Simard, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for adults who've had a coronary angiography or heart intervention via the wrist artery and can consent to participate. It's not for those under 18, with bleeding risks, liver dysfunction, severe anemia, noncompliance history, active cancer, allergy to rivaroxaban, other anticoagulant needs, certain drug use, expected short lifespan, pregnant women not using birth control or with severe kidney disease.

Inclusion Criteria

I have had a heart vessel examination or treatment through my wrist.

Willing and able to provide written informed consent.

Exclusion Criteria

My hemoglobin is below 10 g/dL and the cause is unknown.

I am a woman who can become pregnant and am not using birth control.

My liver is not working well.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive rivaroxaban 15mg tablet orally once daily for 7 days following transradial access

1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of radial artery occlusion and bleeding events

30 days

Treatment Details

Interventions

• Rivaroxaban

Trial Overview The CAPITAL-RAPTOR trial is testing if taking rivaroxaban for one week after wrist artery access during heart procedures can prevent the artery from getting blocked later on. The effect will be checked by ultrasound at 30 days post-procedure.

Participant Groups

Group I: Rivaroxaban Group Experimental Treatment 1 Intervention

Subjects will receive rivaroxaban 15mg tablet to be taken orally once daily for 7 days following transradial access.

Group II: Standard of Care Group Active Control 1 Intervention

Subjects will receive the usual standard of care following transradial access.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Ottawa Heart Institute Research Corporation

Collaborator

Trials

200

Recruited

95,800+

Findings from Research

In a study of 521 patients, short-term use of Rivaroxaban (10 mg for 7 days) significantly reduced the occurrence of radial artery occlusion (RAO) after trans-radial coronary procedures, with rates of 6.9% in the Rivaroxaban group compared to 13% in the control group.

There were no severe bleeding complications reported, and the incidence of minor bleeding was low and similar between the two groups, indicating that Rivaroxaban is a safe option for preventing RAO.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevention of radial artery occlusion with rivaroxaban after trans-radial access coronary procedures: The RIVARAD multicentric randomized trial. Hammami, R., Abid, S., Jihen, J., et al.[2023]

In a study of five patients with radial artery occlusion (RAO) after transradial catheterization, balloon angioplasty combined with a 90-second infusion of abciximab directly at the site of occlusion successfully restored artery patency in all but one patient, who experienced reocclusion after balloon angioplasty alone.

The technique was found to be safe and effective, with all patients remaining symptom-free and showing maintained artery patency at follow-up (average 189 days), suggesting it could be a promising treatment option for RAO.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of radial artery occlusions using balloon angioplasty and localized intra-arterial abciximab. Jaradat, Z., Basir, B., Revtyak, G.[2018]

In a study of 382 patients undergoing transradial coronary procedures, short-term postoperative anticoagulation with rivaroxaban did not significantly reduce the incidence of radial artery occlusion (RAO) within 24 hours, but it did significantly lower the rate of 1-month RAO compared to a placebo group.

Patients receiving rivaroxaban showed a higher rate of recanalization of the radial artery after 24 hours, indicating that while immediate RAO prevention was not achieved, rivaroxaban may enhance long-term outcomes without increasing access-site complications or bleeding events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short-Term Postoperative Use of Rivaroxaban to Prevent Radial Artery Occlusion After Transradial Coronary Procedure: The RESTORE Randomized Trial. Liang, D., Lin, Q., Zhu, Q., et al.[2022]

In a study of 450 patients undergoing cardiac catheterization via the transradial approach, the incidence of radial artery occlusion (RAO) was low across all groups, with no significant difference in RAO rates between 10, 20, and 30 minutes of radial hemostatic device (RHD) time.

The use of small-caliber sheaths without adjunctive heparin resulted in a very low occurrence of forearm hematomas, indicating that shorter RHD times do not significantly reduce the risk of complications like RAO or hematomas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short Durations of Radial Hemostatic Device After Diagnostic Transradial Cardiac Catheterization: The PRACTICAL-2 Randomized Trial. Lavi, S., Mehta, SR., Bajwa, R., et al.[2021]

Radial artery occlusions (RAO) and ulnar artery occlusions (UAO) occur at similar rates of about 7% to 8% when assessed early using vascular ultrasonography after coronary procedures, indicating a significant incidence of these complications.

Higher intensity anticoagulation, specifically high-dose heparin, is associated with a lower rate of RAO compared to low-dose heparin, suggesting that more intensive anticoagulation may help prevent these occlusions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radial Artery and Ulnar Artery Occlusions Following Coronary Procedures and the Impact of Anticoagulation: ARTEMIS (Radial and Ulnar ARTEry Occlusion Meta-AnalysIS) Systematic Review and Meta-Analysis. Hahalis, G., Aznaouridis, K., Tsigkas, G., et al.[2018]

In a study involving 120 high-risk patients with antiphospholipid syndrome, those who switched from rivaroxaban to warfarin experienced significantly fewer thromboembolic events, with only 5.7% of warfarin patients facing complications compared to 33.3% of those remaining on direct oral anticoagulants (DOACs).

The findings indicate that warfarin is a safer and more effective option for preventing thromboembolic events in this patient population, as evidenced by a hazard ratio of 6.9 for increased risk in those on DOACs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trial of Rivaroxaban in AntiPhospholipid Syndrome (TRAPS): Two-year outcomes after the study closure. Pengo, V., Hoxha, A., Andreoli, L., et al.[2023]

In a study involving 120 high-risk patients with thrombotic antiphospholipid syndrome, rivaroxaban was found to be associated with a higher rate of thromboembolic events compared to warfarin, with 12% of patients on rivaroxaban experiencing events like ischemic strokes and myocardial infarctions.

The trial, which had a mean follow-up of 569 days, was terminated early due to the increased risk associated with rivaroxaban, indicating that it does not provide a safety or efficacy advantage over warfarin in this specific patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rivaroxaban vs warfarin in high-risk patients with antiphospholipid syndrome. Pengo, V., Denas, G., Zoppellaro, G., et al.[2021]

A large observational study (XANTUS) involving 6784 patients with non-valvular atrial fibrillation confirmed that rivaroxaban is both effective and safe for preventing strokes and other thromboembolic complications in a real-world clinical setting.

Rivaroxaban was associated with a lower risk of fatal intracranial and gastrointestinal bleeding compared to other treatments, highlighting its safety profile in routine clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Rivaroxaban at Non-Valvular Atrial Fibrillation: a Prospective Study and Clinical Practice]. Fonyakin, AV.[2019]

Rivaroxaban, a new oral anticoagulant, shows a favorable safety profile compared to vitamin K antagonists, with no increased risk of major or clinically relevant nonmajor bleeding in a meta-analysis of 23,063 patients across five trials.

Importantly, rivaroxaban is associated with a significant reduction in fatal bleeding events and does not increase the risk of all-cause mortality, suggesting it may be a safer alternative for patients requiring anticoagulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meta-analysis of rivaroxaban and bleeding risk. Wasserlauf, G., Grandi, SM., Filion, KB., et al.[2015]

Rivaroxaban, a direct factor Xa inhibitor, is effective for preventing and treating thromboembolic disorders, and ongoing research is exploring its broader applications in vascular protection.

Current studies are investigating the potential benefits of rivaroxaban, both alone and in combination with antiplatelet agents, for stroke prevention and venous protection, indicating its expanding role in managing vascular health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Rivaroxaban Program and the Management of Unmet Needs in Thromboembolic Disease. Camm, AJ.[2019]

In a study of 766 patients undergoing joint arthroplasty, no major bleeding events were associated with the use of rivaroxaban for thromboprophylaxis when combined with peripheral nerve blocks.

While some minor bleeding occurred, particularly at the surgical site after starting rivaroxaban, the overall data suggests that using nerve blocks in conjunction with rivaroxaban does not increase the risk of major bleeding.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combination of Superficial and Deep Blocks with Rivaroxaban. Chelly, JE., Metais, B., Schilling, D., et al.[2015]

Rivaroxaban 2.5 mg twice daily, when combined with aspirin or aspirin plus clopidogrel/ticlopidine, significantly reduced the risk of death from cardiovascular causes, myocardial infarction, or stroke in patients with recent acute coronary syndrome, based on the ATLAS ACS 2-TIMI 51 trial involving a median treatment duration of 13.1 months.

While rivaroxaban showed efficacy in reducing cardiovascular events, it also increased the risk of major bleeding and intracranial hemorrhage compared to placebo, although there was no increase in fatal bleeding, highlighting the need for careful monitoring in patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rivaroxaban: a review of its use in acute coronary syndromes. Plosker, GL.[2021]

Rivaroxaban, an oral anticoagulant that inhibits Factor Xa, is used to prevent blood clots in conditions like atrial fibrillation and deep venous thrombosis.

A case report highlights a potential safety concern, as a 75-year-old woman developed a spontaneous rectus sheath hematoma while on rivaroxaban therapy, indicating the need for careful monitoring in older patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spontaneous rectus sheath hematoma during rivaroxaban therapy. Kocayigit, I., Can, Y., Sahinkus, S., et al.[2021]

Rivaroxaban, at doses of 1 and 3 mg/kg, effectively prevented arterial occlusion in a rat model, demonstrating superior efficacy compared to enoxaparin (10 mg/kg), which only delayed occlusion for an average of 21.6 minutes.

The study indicates that rivaroxaban's antithrombotic effects are associated with dose-dependent increases in prothrombin time and activated clotting time, suggesting its potential use in treating arterial thrombotic conditions like acute coronary syndrome and stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Arterial antithrombotic activity of rivaroxaban, an orally active factor Xa inhibitor, in a rat electrolytic carotid artery injury model of thrombosis. Parry, TJ., Huang, Z., Chen, C., et al.[2022]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Prevention of radial artery occlusion with rivaroxaban after trans-radial access coronary procedures: The RIVARAD multicentric randomized trial. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Treatment of radial artery occlusions using balloon angioplasty and localized intra-arterial abciximab. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Short-Term Postoperative Use of Rivaroxaban to Prevent Radial Artery Occlusion After Transradial Coronary Procedure: The RESTORE Randomized Trial. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Short Durations of Radial Hemostatic Device After Diagnostic Transradial Cardiac Catheterization: The PRACTICAL-2 Randomized Trial. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Radial Artery and Ulnar Artery Occlusions Following Coronary Procedures and the Impact of Anticoagulation: ARTEMIS (Radial and Ulnar ARTEry Occlusion Meta-AnalysIS) Systematic Review and Meta-Analysis. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Trial of Rivaroxaban in AntiPhospholipid Syndrome (TRAPS): Two-year outcomes after the study closure. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Rivaroxaban vs warfarin in high-risk patients with antiphospholipid syndrome. [2021]

8. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Rivaroxaban at Non-Valvular Atrial Fibrillation: a Prospective Study and Clinical Practice]. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Meta-analysis of rivaroxaban and bleeding risk. [2015]

10. Germany pubmed.ncbi.nlm.nih.gov

The Rivaroxaban Program and the Management of Unmet Needs in Thromboembolic Disease. [2019]

11. England pubmed.ncbi.nlm.nih.gov

Combination of Superficial and Deep Blocks with Rivaroxaban. [2015]

12. New Zealand pubmed.ncbi.nlm.nih.gov

Rivaroxaban: a review of its use in acute coronary syndromes. [2021]

13. India pubmed.ncbi.nlm.nih.gov

Spontaneous rectus sheath hematoma during rivaroxaban therapy. [2021]

14. England pubmed.ncbi.nlm.nih.gov

Arterial antithrombotic activity of rivaroxaban, an orally active factor Xa inhibitor, in a rat electrolytic carotid artery injury model of thrombosis. [2022]