What side effects are associated with this type of intervention?

Ticagrelor, an antiplatelet agent, is commonly associated with side effects such as dyspnea (shortness of breath), bleeding, and, less frequently, bradyarrhythmias. Rivaroxaban, an anticoagulant, primarily increases the risk of bleeding, including major bleeding events. Both medications aim to reduce the risk of thrombotic events but require careful monitoring to balance efficacy and safety, particularly in patients with a high risk of bleeding.

What prior FDA approvals exist?

The FDA has approved several antiplatelet and anticoagulant drugs for the treatment of Acute Coronary Syndrome (ACS). Ticagrelor, an antiplatelet agent, was approved for reducing the rate of thrombotic cardiovascular events in patients with ACS. It works by inhibiting platelet aggregation. Another key antiplatelet drug is Clopidogrel, which has been widely used in combination with aspirin. For anticoagulation, Rivaroxaban, a direct oral anticoagulant, has been approved for reducing the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation and for the treatment of deep vein thrombosis and pulmonary embolism. These drugs are part of the broader strategy to manage ACS by preventing clot formation and improving patient outcomes.

What other types of research exist?

For antiplatelet therapy, novel alternatives to Ticagrelor include Cangrelor, an intravenous P2Y12 inhibitor, which has shown promise in reducing thrombotic events during percutaneous coronary intervention (PCI). For anticoagulant therapy, alternatives to Rivaroxaban include Edoxaban, an oral factor Xa inhibitor, which has demonstrated efficacy in stroke prevention and reducing bleeding risk in atrial fibrillation patients. Both drugs are being explored for broader applications in ACS management.

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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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

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.

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.

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.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Composite of TIMI Bleeds

Secondary study objectives

The composite of multiple adverse cardiovascular events (MACE)

The frequency of the individual components of the primary endpoint

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

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

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Antiplatelet agents like Ticagrelor inhibit platelet aggregation, preventing the formation and growth of clots in the arteries, which is crucial for Acute Coronary Syndrome (ACS) patients to avoid myocardial infarction. Anticoagulants like Rivaroxaban inhibit specific factors in the coagulation cascade, reducing the blood's ability to clot and preventing thrombus formation that can obstruct coronary arteries. These mechanisms are essential in managing ACS to reduce the risk of further cardiovascular events and improve patient outcomes.