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

Palo Alto (17 mi)

Overseen byMichel Le May, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Ottawa Heart Institute Research Corporation

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial is testing a new combination of two drugs, ticagrelor and rivaroxaban, for patients with atrial fibrillation who have had heart artery procedures. The goal is to see if this combination can reduce the risk of heart attacks and strokes with fewer bleeding complications compared to current treatments.

Eligibility Criteria

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.

Treatment Details

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.

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.

Rivaroxaban is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Xarelto for: