1800 Participants Needed

Blood Thinner for Radial Artery Occlusion

(CAPITAL-RAPTOR Trial)

Recruiting at 2 trial locations
PD
BH
Overseen ByBenjamin Hibbert, MD PhD
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Ottawa Heart Institute Research Corporation
No Placebo GroupAll 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 DataThis treatment has passed at least one previous human trial
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a blood thinner called rivaroxaban (Xarelto) to determine if it can prevent radial artery occlusion, a common complication after heart procedures through the wrist. The trial seeks to discover if taking rivaroxaban for a week post-procedure can keep the artery open and prevent future issues. Participants are divided into two groups: one taking rivaroxaban and the other receiving standard care without the drug. Individuals who have undergone a heart procedure through the wrist and do not have a history of bleeding problems or certain health conditions might be suitable for this trial. As a Phase 3 trial, this study represents the final step before potential FDA approval, offering participants a chance to contribute to a treatment nearing widespread availability.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that rivaroxaban is generally well-tolerated, making it a promising option for preventing complications like radial artery occlusion, a blockage of the artery in the wrist, after certain heart procedures. Studies have demonstrated that rivaroxaban significantly reduces the risk of this type of artery blockage compared to not using any blood thinner. For instance, one study found that the rate of radial artery occlusion decreased to 6.9% with rivaroxaban, compared to 13% without it.

Rivaroxaban is a blood thinner known as a direct oral anticoagulant (DOAC), which helps prevent blood clots. It is considered safer than older blood thinners, like vitamin K antagonists, because it is generally better tolerated and causes fewer serious side effects. For those considering participation in a trial involving rivaroxaban, these findings suggest it is a relatively safe choice with a good track record in similar situations.12345

Why do researchers think this study treatment might be promising?

Most treatments for radial artery occlusion focus on surgical interventions or traditional anticoagulants like heparin or warfarin. However, Rivaroxaban, an investigational treatment, offers a unique approach. It is an oral anticoagulant that specifically targets Factor Xa, a key enzyme in the blood clotting process, which could offer a more direct mechanism of action. Unlike other blood thinners that require regular blood monitoring and dietary restrictions, Rivaroxaban provides a simpler, once-daily oral dosing without these limitations. Researchers are excited about its potential to improve patient convenience and reduce the risk of complications associated with traditional anticoagulants.

What evidence suggests that rivaroxaban might be an effective treatment for radial artery occlusion?

In this trial, participants will join one of two groups to evaluate the effectiveness of rivaroxaban in preventing radial artery occlusion. Research has shown that rivaroxaban, a blood-thinning medication, can reduce the risk of radial artery blockage after certain heart procedures. One study found that patients taking rivaroxaban had a lower rate of artery blockage—6.9% compared to 13% in those not taking it. This suggests rivaroxaban may reduce the risk by about half. Another study found significant improvement in many patients, with about 81% experiencing partial or complete clearing of their blockages. These findings suggest that rivaroxaban could help keep the radial artery open and prevent complications after procedures involving this artery.12346

Are You a Good Fit for This Trial?

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.

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.
See 21 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

  • Rivaroxaban
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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: RivaroxabanExperimental Treatment1 Intervention
Group II: Standard of CareActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ottawa Heart Institute Research Corporation

Lead Sponsor

Trials
200
Recruited
95,800+

Published Research Related to This Trial

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.
Meta-analysis of rivaroxaban and bleeding risk.Wasserlauf, G., Grandi, SM., Filion, KB., et al.[2015]
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.
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 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.
Mortality Benefit of Rivaroxaban Plus Aspirin in Patients With Chronic Coronary or Peripheral Artery Disease.Eikelboom, JW., Bhatt, DL., Fox, KAA., et al.[2021]

Citations

Prevention of radial artery occlusion with rivaroxaban after ...The 1-month RAO was significantly reduced in the Rivaroxaban Group as compared to the Control Group [6.9% vs. 13%; p = 0.011, OR = 0.5, (95% CI, ...
Short-Term Postoperative Use of Rivaroxaban to Prevent ...The RESTORE trial (Short-term postoperative use of Rivaroxaban to prevent RAO after transradial coronary procedure) was a randomized, placebo- ...
Rivaroxaban versus Enoxaparin in Patients with Radial ...In 30 of 37 (81.1%) patients, RAO showed either partial resolution (29.7%) or complete resolution (51.4%). There was no statistically ...
Rivaroxaban Post-Transradial Access for the Prevention of ...Outcome Measure, Measure Description, Time Frame. Primary efficacy outcome - rate of radial artery occlusion, Presence of radial artery occlusion at 30 days ...
Treatment of radial artery occlusion after transradial ...Among the patients receiving anticoagulation, 21.3% exhibited full patency of the artery on follow-up, as opposed to 11.4% of the control group (p = 0.07), ...
Rationale and Design of the Rivaroxaban Post-Transradial ...The CAPITAL-RAPTOR study aims to evaluate the efficacy and safety of short-term rivaroxaban in preventing RAO following TRA. While the pathophysiology of RAO is ...
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