← Back to Search

Anticoagulant

Rivaroxaban + Ticagrelor for Atrial Fibrillation After Stent Placement (CAPITAL PCI AF Trial)

Phase 3
Waitlist Available
Led By Michel Le May, MD
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
Patient has undergone a PCI with stent placement
Atrial flutter can be included as 'AF equivalent'
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

CAPITAL PCI AF Trial Summary

This trial is studying the combination of two potent drugs, ticagrelor and rivaroxaban, in AF patients receiving a stent placement, in order to gain insight into the management of these high-risk patients.

Who is the study for?
This trial is for adults with atrial fibrillation or flutter who've had a stent placed via PCI within the last year. They must have non-valvular AF, not be pregnant, and have no major recent surgeries or conditions that increase bleeding risk. People with severe liver disease, low hemoglobin levels, or certain drug interactions are excluded.Check my eligibility
What is being tested?
The study tests the combination of Ticagrelor (a blood thinner given after stent placement) and Rivaroxaban (an oral anticoagulant for AF) to manage patients at high risk of heart issues post-PCI. It aims to see if this combo reduces bleeding compared to traditional triple therapy.See study design
What are the potential side effects?
Potential side effects include increased risk of bleeding complications due to the blood-thinning properties of both drugs. Other possible side effects may involve bruising easily, nosebleeds, gastrointestinal bleeding, and in rare cases more serious internal bleeding.

CAPITAL PCI AF Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have had a procedure called PCI with stent placement.
Select...
Atrial flutter can be considered as an equivalent to atrial fibrillation.
Select...
You have been diagnosed with non-valvular atrial fibrillation within the past year, or more than a year ago if you have been taking oral anticoagulation therapy for at least 3 months before the procedure.
Select...
You don't have a certain type of heart condition called non-valvular atrial fibrillation or a specific problem with your heart valve.

CAPITAL PCI AF Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Composite of TIMI Bleeds
Secondary outcome measures
All-cause mortality
The composite of multiple adverse cardiovascular events (MACE)
The frequency of stent thrombosis
+1 more

CAPITAL PCI AF Trial Design

1Treatment groups
Experimental Treatment
Group I: Ticagrelor and RivaroxabanExperimental Treatment2 Interventions
All participants will be prescribed ticagrelor 90 mg twice daily and rivaroxaban 15 mg once daily for a year.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ticagrelor
2014
Completed Phase 4
~2720
Rivaroxaban
2015
Completed Phase 4
~157350

Find a Location

Who is running the clinical trial?

Ottawa Heart Institute Research CorporationLead Sponsor
188 Previous Clinical Trials
92,534 Total Patients Enrolled
11 Trials studying Acute Coronary Syndrome
3,474 Patients Enrolled for Acute Coronary Syndrome
Michel Le May, MDPrincipal InvestigatorOttawa Heart Institute Research Corporation
1 Previous Clinical Trials
113 Total Patients Enrolled

Media Library

Rivaroxaban (Anticoagulant) Clinical Trial Eligibility Overview. Trial Name: NCT03331484 — Phase 3
Acute Coronary Syndrome Research Study Groups: Ticagrelor and Rivaroxaban
Acute Coronary Syndrome Clinical Trial 2023: Rivaroxaban Highlights & Side Effects. Trial Name: NCT03331484 — Phase 3
Rivaroxaban (Anticoagulant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03331484 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has this therapeutical procedure received FDA clearance?

"Since this is a Phase 3 trial, there is more safety data available for this treatment than others. Our team gives it a score of 3."

Answered by AI

How many individuals are involed in this test?

"Unfortunately, this particular study is no longer admitting patients. Although, if you are still interested in atrial fibrillation research, there are 632 other studies and 104 trials that might be a better fit."

Answered by AI

What are the primary purposes of this medication?

"Acute chest syndrome is often treated with this intervention. This particular treatment is also effective for thrombosis, prophylaxis of systemic embolism, and reducing cardiovascular mortality."

Answered by AI
~6 spots leftby Mar 2025