Blood Thinner for Radial Artery Occlusion

(CAPITAL-RAPTOR Trial)

Recruiting at1 trial location

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Ottawa Heart Institute Research Corporation

Must not be taking: NSAIDs, CYP3A4 inhibitors

Disqualifiers: Bleeding risk, Liver dysfunction, others

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial is testing if taking a pill after a coronary procedure can prevent artery blockage. It focuses on patients who have the procedure done through their wrist artery. The goal is to see if this pill can help keep the artery open for future use.

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 non-steroidal anti-inflammatory medications or certain other drugs, you may not be eligible to participate.

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

Research shows that Rivaroxaban, when combined with aspirin, reduces major cardiovascular events and mortality in patients with coronary or peripheral artery disease. This suggests that Rivaroxaban may be effective in improving blood flow and reducing complications in similar conditions. ^{1 2 3 4 5}

Is Rivaroxaban generally safe for humans?

Rivaroxaban has been shown to have a favorable safety profile in terms of bleeding, with a decrease in fatal bleeding compared to other blood thinners, although it may increase the risk of certain events in high-risk patients with specific conditions like antiphospholipid syndrome. ^{6 7 8 9 10}

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

Rivaroxaban is unique because it is an oral medication that directly inhibits factor Xa, a key protein in the blood clotting process, which helps prevent arterial thrombosis. Unlike some other blood thinners that require injections or regular blood monitoring, rivaroxaban is taken as a simple daily pill and does not need frequent dose adjustments. ^{4 11 12 13 14}

Research Team

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 with upcoming surgeries, certain heart issues, pregnancy without birth control, bleeding risks, severe liver or kidney disease, recent strokes, allergies to rivaroxaban, or on specific drugs.

Inclusion Criteria

Willing and able to provide written informed consent

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

I am 18 years old or older.

Exclusion Criteria

My heart's rhythm problems don't improve with treatment.

I am scheduled for heart or other surgery within the next 30 days.

I have received clot-dissolving medication in the last 24 hours.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

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

1 week

Follow-up

Participants are monitored for radial artery patency/occlusion and other outcomes using Doppler ultrasound

30 days

Treatment Details

Interventions

• Rivaroxaban (Anticoagulant)

Trial Overview The study tests if taking Rivaroxaban (a blood thinner) orally once daily for a week after wrist artery access can prevent the artery from closing up. This complication happens in about 5% of cases and prevents future use of this artery.

Participant Groups

Group I: Rivaroxaban Experimental Treatment 1 Intervention

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.

Group II: Standard of Care Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Ottawa Heart Institute Research Corporation

Lead Sponsor

Trials

200

Recruited

95,800+

Dr. Thierry Mesana

Ottawa Heart Institute Research Corporation

Chief Medical Officer since 2014

MD from McGill University

Dr. Rob Beanlands

Ottawa Heart Institute Research Corporation

Chief Executive Officer since 2024

MD from the University of Ottawa

Findings from Research

In the COMPASS trial involving 27,395 patients, the combination of 2.5 mg rivaroxaban twice daily and 100 mg aspirin once daily significantly reduced overall mortality compared to aspirin alone, with a hazard ratio of 0.82 over a median follow-up of 23 months.

The combination therapy also led to a significant reduction in cardiovascular (CV) deaths (1.7% vs 2.2% for aspirin alone), particularly benefiting patients with higher baseline risk factors, indicating a tailored approach to treatment could enhance outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mortality Benefit of Rivaroxaban Plus Aspirin in Patients With Chronic Coronary or Peripheral Artery Disease. Eikelboom, JW., Bhatt, DL., Fox, KAA., et al.[2021]

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]

In a trial involving 27,395 patients with stable coronary artery disease or peripheral artery disease, the combination of rivaroxaban and aspirin reduced the risk of cardiovascular death, stroke, or heart attack by 24% and decreased overall mortality by 18%.

Rivaroxaban alone did not provide additional benefits compared to aspirin, but the combination therapy also significantly lowered the risk of major limb events, such as amputations, in patients with peripheral artery disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-dose rivaroxaban plus aspirin for the prevention of cardiovascular events: an evaluation of COMPASS. Bhagirath, VC., Eikelboom, JW., Anand, SS.[2019]

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]

Rivaroxaban combined with aspirin is more effective in preventing recurrent cardiovascular events than aspirin alone, with an incremental cost-effectiveness ratio (ICER) of €16,522 per quality-adjusted life-year (QALY) gained, based on a lifetime analysis of patients with coronary artery disease (CAD) or peripheral artery disease (PAD).

The cost-effectiveness of the combination therapy was consistent across subgroups, showing ICERs of €8003 for PAD and €18,599 for CAD, indicating that this treatment strategy is economically viable for improving cardiovascular outcomes in these patient populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cost-Effectiveness Analysis of Rivaroxaban Plus Aspirin Compared with Aspirin Alone in Patients with Coronary and Peripheral Artery Diseases in Italy. Ferrara, P., Cortesi, PA., Di Laura, D., et al.[2022]

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]

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 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]

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, 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]

Rivaroxaban is an effective oral medication that inhibits Factor Xa, showing significant efficacy in preventing and treating thromboembolic disorders, including venous thromboembolism after major orthopedic surgery.

In phase III studies, rivaroxaban was found to be more effective than enoxaparin for preventing blood clots after knee surgery, with a similar low risk of bleeding, making it a promising alternative to existing treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rivaroxaban. A novel, oral, direct factor Xa inhibitor in clinical development for the prevention and treatment of thromboembolic disorders. Perzborn, E., Kubitza, D., Misselwitz, F.[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]

References

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

Mortality Benefit of Rivaroxaban Plus Aspirin in Patients With Chronic Coronary or Peripheral Artery Disease. [2021]

2. England pubmed.ncbi.nlm.nih.gov

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

3. England pubmed.ncbi.nlm.nih.gov

Low-dose rivaroxaban plus aspirin for the prevention of cardiovascular events: an evaluation of COMPASS. [2019]

4. Germany pubmed.ncbi.nlm.nih.gov

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

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

Cost-Effectiveness Analysis of Rivaroxaban Plus Aspirin Compared with Aspirin Alone in Patients with Coronary and Peripheral Artery Diseases in Italy. [2022]

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

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

7. 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]

8. 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]

9. England pubmed.ncbi.nlm.nih.gov

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

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

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

11. 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]

12. Germany pubmed.ncbi.nlm.nih.gov

Rivaroxaban. A novel, oral, direct factor Xa inhibitor in clinical development for the prevention and treatment of thromboembolic disorders. [2015]

13. Belgium pubmed.ncbi.nlm.nih.gov

[Rivaroxaban (Xarelto): new anticoagulant inhibitor of factor Xa]. [2015]

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

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