Rivaroxaban for Tubal Occlusion

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Mayo Clinic Rochester, Rochester, MN
Tubal Occlusion+1 More
Rivaroxaban - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

Transradial access (TRA) is the preferred vascular access site for invasive coronary angiography. TRA is limited by blockage of the radial artery post-procedurally, preventing future use of TRA. This is referred to as radial artery occlusion (RAO) and occurs in ~5% of cases. While intraprocedural anticoagulation has been studied extensively to mitigate this complication, oral anticoagulation post-TRA has not. The investigators will assess the impact of a one-week course of rivaroxaban post-TRA to reduce the rate of ultrasound-defined RAO at 30 days.

Eligible Conditions

  • Tubal Occlusion

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

2 Primary · 11 Secondary · Reporting Duration: 30 days

30 days
All-Cause Mortality
BARC bleeding criteria
Bleeding requiring medical attention
Fatal bleeding
GUSTO bleeding criteria
Myocardial infarction
Primary Efficacy Outcome - Radial Artery Occlusion
Primary Safety Outcome - Major Bleeding
Stent thrombosis
Stroke (hemorrhagic)
Stroke (ischemic or uncertain)
Symptomatic bleeding in a critical area or organ
TIMI bleeding criteria

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Side Effects for

Rivaroxaban
24%Others
4%Constipation
4%Hypertension
3%Dizziness
3%Nausea
2%Anaemia
2%Musculoskeletal pain
1%Large intestine polyp
1%International normalised ratio increased
1%Cerebral infarction
1%Depression
1%Hypotension
1%Atrial fibrillation
1%Gastrooesophageal reflux disease
1%Stroke in evolution
1%Insomnia
0%Nasopharyngitis
0%Laboratory test abnormal
0%Vertigo positional
0%Arthritis
0%Pulmonary hypertension
0%Decreased appetite
0%Delirium
This histogram enumerates side effects from a completed 2015 Phase 2 trial (NCT02042534) in the Rivaroxaban ARM group. Side effects include: Others with 24%, Constipation with 4%, Hypertension with 4%, Dizziness with 3%, Nausea with 3%.

Trial Design

2 Treatment Groups

Standard of Care Group
1 of 2
Rivaroxaban Group
1 of 2
Active Control
Experimental Treatment

700 Total Participants · 2 Treatment Groups

Primary Treatment: Rivaroxaban · No Placebo Group · Phase 3

Rivaroxaban Group
Drug
Experimental Group · 1 Intervention: Rivaroxaban · Intervention Types: Drug
Standard of Care GroupNoIntervention Group · 1 Intervention: Standard of Care Group · Intervention Types:
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rivaroxaban
2015
Completed Phase 4
~199370

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 30 days
Closest Location: Mayo Clinic Rochester · Rochester, MN
Photo of Mayo Clinic Rochester 1Photo of Mayo Clinic Rochester 2Photo of Mayo Clinic Rochester 3
2005First Recorded Clinical Trial
0 TrialsResearching Tubal Occlusion
157 CompletedClinical Trials

Who is running the clinical trial?

Mayo ClinicLead Sponsor
2,860 Previous Clinical Trials
3,685,461 Total Patients Enrolled
Ottawa Heart Institute Research CorporationOTHER
176 Previous Clinical Trials
87,288 Total Patients Enrolled
Trevor SimardPrincipal InvestigatorMayo Clinic

Eligibility Criteria

Age 18+ · All Participants · 2 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.