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Rivaroxaban for Radial Artery Occlusion

Phase 3
Recruiting
Led By Trevor Simard
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnostic coronary angiography or percutaneous coronary intervention via the transradial approach.
Be older than 18 years old
Must not have
Unexplained anemia with hemoglobin below 10 g/dL.
Women capable of pregnancy not on birth control.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial will assess whether a one-week course of rivaroxaban can reduce the rate of blockage of the radial artery after 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 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.
What is being tested?
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.
What are the potential side effects?
Rivaroxaban may cause bleeding complications; it's important to monitor any signs of excessive bruising or bleeding. Other side effects might include allergic reactions and potential interactions with specific drugs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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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:
Select...
My hemoglobin is below 10 g/dL and the cause is unknown.
Select...
I am a woman who can become pregnant and am not using birth control.
Select...
My liver is not working well.
Select...
I need blood thinners for another health reason.
Select...
I am at high risk for bleeding or cannot take blood thinners due to recent serious bleeding, low platelets, brain hemorrhage, certain heart procedures, stroke, or use of specific medications.
Select...
I am not taking any CYP3A4 or P-glycoprotein inhibitors.
Select...
I currently have cancer.
Select...
My kidneys are not working well, with a creatinine clearance under 30mL/min.
Select...
I had a failed attempt at getting another artery access for treatment.
Select...
My heart has irregular beats that medicine can't control.
Select...
I am scheduled for heart or other surgery within the next 30 days.
Select...
I have a noticeable bruise or bleeding concern where my wrist was accessed.
Select...
I have a condition where my heart can't pump enough blood to meet my body's needs.
Select...
I am under 18 years old.

Timeline

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 - Radial Artery Occlusion
Primary Safety Outcome - Major Bleeding
Secondary study objectives
All-Cause Mortality
BARC bleeding criteria
Bleeding requiring medical attention
+8 more

Side effects data

From 2020 Phase 3 trial • 179 Patients • NCT02164578
2%
Hypertensive crisis
1%
Diverticulitis
1%
Chest pain
1%
Bile duct stone
1%
Cerebrovascular accident
1%
Nausea
1%
Foot fracture
1%
Erysipelas
1%
Vomiting
1%
Intervertebral disc protrusion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Aspirin
Rivaroxaban

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: Rivaroxaban GroupExperimental Treatment1 Intervention
Subjects will receive rivaroxaban 15mg tablet to be taken orally once daily for 7 days following transradial access.
Group II: Standard of Care GroupActive Control1 Intervention
Subjects will receive the usual standard of care following transradial access.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rivaroxaban
2015
Completed Phase 4
~157350

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,362 Previous Clinical Trials
3,065,306 Total Patients Enrolled
Ottawa Heart Institute Research CorporationOTHER
196 Previous Clinical Trials
92,997 Total Patients Enrolled
1 Trials studying Radial Artery Occlusion
1,800 Patients Enrolled for Radial Artery Occlusion
Trevor SimardPrincipal InvestigatorMayo Clinic
Trevor Simard, MDPrincipal InvestigatorMayo Clinic

Media Library

Rivaroxaban Clinical Trial Eligibility Overview. Trial Name: NCT05399277 — Phase 3
Radial Artery Occlusion Research Study Groups: Rivaroxaban Group, Standard of Care Group
Radial Artery Occlusion Clinical Trial 2023: Rivaroxaban Highlights & Side Effects. Trial Name: NCT05399277 — Phase 3
Rivaroxaban 2023 Treatment Timeline for Medical Study. Trial Name: NCT05399277 — Phase 3
~359 spots leftby Sep 2026
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