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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I have had a heart vessel examination or treatment through my wrist.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
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 - Radial Artery Occlusion
Primary Safety Outcome - Major Bleeding
Secondary outcome measures
All-Cause Mortality
BARC bleeding criteria
Bleeding requiring medical attention
+8 moreSide effects data
From 2020 Phase 3 trial • 179 Patients • NCT021645782%
Hypertensive crisis
1%
Intervertebral disc protrusion
1%
Erysipelas
1%
Bile duct stone
1%
Diverticulitis
1%
Foot fracture
1%
Chest pain
1%
Nausea
1%
Vomiting
1%
Cerebrovascular accident
100%
80%
60%
40%
20%
0%
Study treatment Arm
Aspirin
Rivaroxaban
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
3,207 Previous Clinical Trials
3,766,440 Total Patients Enrolled
Ottawa Heart Institute Research CorporationOTHER
188 Previous Clinical Trials
91,736 Total Patients Enrolled
1 Trials studying Radial Artery Occlusion
1,800 Patients Enrolled for Radial Artery Occlusion
Trevor SimardPrincipal InvestigatorMayo Clinic
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My hemoglobin is below 10 g/dL and the cause is unknown.I am a woman who can become pregnant and am not using birth control.My liver is not working well.I need blood thinners for another health reason.I have had a heart vessel examination or treatment through my wrist.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.You have a history of a specific type of antiphospholipid syndrome with certain antibodies.You are expected to live less than 30 days.I am not taking any CYP3A4 or P-glycoprotein inhibitors.I currently have cancer.My kidneys are not working well, with a creatinine clearance under 30mL/min.You are allergic to rivaroxaban.I had a failed attempt at getting another artery access for treatment.My heart has irregular beats that medicine can't control.I am scheduled for heart or other surgery within the next 30 days.I have a noticeable bruise or bleeding concern where my wrist was accessed.I have a condition where my heart can't pump enough blood to meet my body's needs.I am under 18 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Rivaroxaban Group
- Group 2: Standard of Care Group
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the intention of this clinical trial?
"The objectives of this month-long study will be to track and compare the rates of major bleeding between the patients. Additionally, data on fatal bleeding, Bleeding Academic Research Consortium (BARC) bleeding, and Thrombolysis in Myocardial Infarction (TIMI) criteria will be collected."
Answered by AI
Could you please outline Rivaroxaban's potential side effects?
"There is some efficacy data from previous clinical trials and multiple rounds of data supporting Rivaroxaban's safety, so it received a score of 3."
Answered by AI
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