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

Must not have

Access or attempted access at a second site - including contralateral radial artery, brachial, or femoral artery or vein

Ventricular arrhythmias refractory to treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

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.

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had or attempted to have a procedure through another artery or vein.

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

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

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

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I cannot take blood thinners due to a high risk of bleeding.

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My liver is not working well.

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I need blood thinners for another health condition.

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I have been diagnosed with antiphospholipid antibody syndrome.

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I have a noticeable bruise or bleeding concern where my wrist was accessed.

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I have experienced a severe heart condition that suddenly reduced blood flow.

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My kidneys are not working well, with a creatinine clearance under 30mL/min.

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My hemoglobin level is below 10 g/dL without a known cause.

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I have had a brain bleed in the past.

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I currently have cancer.

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I have used IIb/IIIa inhibitors during heart artery procedures.

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I have had bleeding that needed medical care in the last 6 months.

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I am not taking any CYP3A4 or P-glycoprotein inhibitors.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Primary efficacy outcome - rate of radial artery occlusion

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

Secondary study objectives

All cause mortality

BARC bleeding criteria

Bleeding requiring medical attention

+8 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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 / 19Eligibility 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.