What side effects are associated with this type of intervention?

Common treatments for Radial Artery Occlusion, such as Rivaroxaban, which inhibits Factor Xa to reduce thrombus formation, are associated with several side effects. These include bleeding complications like gastrointestinal bleeding and intracranial hemorrhage, anemia, elevated liver enzymes, and rare hypersensitivity reactions. Despite these risks, DOACs like Rivaroxaban are often preferred over vitamin K antagonists due to their generally safer profile.

What prior FDA approvals exist?

The FDA has approved several anticoagulants that inhibit Factor Xa for various thrombotic conditions, including Rivaroxaban, Apixaban, and Edoxaban. These drugs are primarily used to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, treat deep vein thrombosis (DVT), and prevent pulmonary embolism (PE). While specific FDA approvals for the treatment of Radial Artery Occlusion are not detailed, the use of Rivaroxaban in the context of preventing thrombus formation post-transradial access suggests its potential applicability in this area.

What other types of research exist?

Promising novel alternatives to Rivaroxaban for radial artery occlusion patients include: 1) Concizumab, a monoclonal antibody against tissue factor pathway inhibitor (TFPI), which has shown significant reduction in bleeding rates in hemophilia patients. 2) Marstacimab, another monoclonal antibody against TFPI, which can be administered subcutaneously or intravenously and has shown efficacy in reducing bleeding events. Both agents represent novel approaches by targeting the TFPI pathway, offering potential benefits in anticoagulation therapy.

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Blood Thinner for Radial Artery Occlusion (CAPITAL-RAPTOR Trial)

Phase 3

Recruiting

Research Sponsored by Ottawa Heart Institute Research Corporation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 18 years

Diagnostic coronary angiography or percutaneous coronary intervention via the transradial approach

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days

Awards & highlights

CAPITAL-RAPTOR Trial Summary

This trial will test whether a blood thinner can reduce the risk of a common complication from a heart procedure.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Rivaroxaban may cause bleeding problems including serious internal bleeds. Other possible side effects include allergic reactions and liver enzyme changes which could indicate liver damage.

CAPITAL-RAPTOR Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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

CAPITAL-RAPTOR Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Primary efficacy outcome - rate of radial artery occlusion

Primary safety outcome - International Society on Thrombosis and Haemostasis definition of major bleeding

Secondary outcome measures

All cause mortality

BARC bleeding criteria

Bleeding requiring medical attention

+8 more

CAPITAL-RAPTOR Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: RivaroxabanExperimental Treatment1 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 CareActive Control1 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.

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Radial Artery Occlusion, such as Rivaroxaban, work by inhibiting Factor Xa, a key enzyme in the coagulation cascade, thereby reducing thrombus formation. This is crucial for patients as it helps prevent the artery from becoming blocked by clots, ensuring it remains open for future use. Other similar treatments include direct oral anticoagulants like apixaban and dabigatran, which also target specific factors in the coagulation pathway to prevent clot formation. These treatments are important because they offer effective anticoagulation with a lower risk of bleeding complications compared to traditional vitamin K antagonists like warfarin.