The Safety and Efficacy Of Rivaroxaban and Ticagrelor for Patients With Atrial Fibrillation After Percutaneous Coronary Intervention

NCT03331484 | Completed Phase 3 DMC

• 1 other identifier: MRL-PCI AF
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Currently, there is minimal data on the combination of rivaroxaban and ticagrelor in patients with atrial fibrillation (AF) managed with percutaneous coronary intervention (PCI). Furthermore, there exists significant controversy among physicians in the use of oral anticoagulants in conjunction with antiplatelet therapy in this population. The present recommendation is triple therapy (aspirin + clopidogrel + warfarin), which has been related to major bleeding complications. Previous studies have shown that ticagrelor has been proven to be more effective in reducing the rate of death, new heart attacks, or strokes than the previously recommended drug, clopidogrel, and studies have shown that less bleeding occurs with rivaroxaban than with warfarin. Therefore, it would be ideal to investigate the two potent drugs, ticagrelor and rivaroxaban, in combination in order to gain insight in the management of these high-risk patients. The CAPITAL PCI AF study is a phase 3 Health Canada regulated interventional study involving the use of investigational drugs. It is a non-randomized, open-design study. The investigational team is studying the highly potent drug Ticagrelor, which is prescribed to participants receiving a stent placement, given in combination with Rivaroxaban, an oral anticoagulant recommended for patients with AF. The primary clinical endpoint is a safety outcome measuring bleeding complications in participants with AF treated within one year of the index PCI. The primary efficacy endpoint is measured by the clinical outcomes of death, stroke, non-central nervous system systemic embolism, myocardial infarction, and stent thrombosis within one year of the index PCI.

Conditions

Atrial Fibrillation; Acute Coronary Syndrome

Keywords

percutaneous coronary intervention; bleeding; atrial fibrillation; Ticagrelor; Rivaroxaban

Outcome Measures

Primary Outcomes (1)

• Composite of TIMI Bleeds

  Composite of TIMI Major Bleed, Minor Bleed, and Bleeding requiring medical attention

  12 months

Secondary Outcomes (4)

• The frequency of the individual components of the primary endpoint

  12 months

• The composite of multiple adverse cardiovascular events (MACE)

  12 months

• The frequency of stent thrombosis

  12 months

• All-cause mortality

  12 months

Study Arms (1)

Ticagrelor and Rivaroxaban

OTHER

All participants will be prescribed ticagrelor 90 mg twice daily and rivaroxaban 15 mg once daily for a year.

Drug: Ticagrelor; Drug: Rivaroxaban

Interventions

Ticagrelor DRUG

Ticagrelor 90 mg twice daily

Ticagrelor and Rivaroxaban

Rivaroxaban DRUG

Rivaroxaban 15 mg once daily (10mg for patients with moderate renal impairment, creatinine clearance: 30-50 mL/min by the Cockcoft Gault method)

Ticagrelor and Rivaroxaban

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient has undergone a PCI with stent placement, plus
• Documented non-valvular atrial fibrillation (AF)\* within 1 year before screening, OR \>1 year before screening if patient had been receiving oral anticoagulation (OAC)therapy for the atrial fibrillation for 3 months immediately before the index PCI.
• AF is defined by its presence on an electrocardiogram (ECG), Holter monitor, or any device that provides a rhythm strip documenting paroxysmal, persistent or, permanent atrial fibrillation.
• Atrial flutter can be included as "AF equivalent". The stroke risk in patients with atrial flutter is not much different from that in AF. Furthermore, many patients diagnosed with atrial flutter subsequently develop AF. Hence, current guidelines recommend that OAC should be used in patients with atrial flutter similar to that in patients with AF.
• Non-valvular AF is defined as the absence of moderate to severe mitral stenosis or the presence of a mechanical valve as per 2016 ESC guidelines.

You may not qualify if:

• Age \<18 years old
• Any condition that contraindicates anticoagulant therapy or would confer an unacceptable risk of bleeding, such as, but not limited to:
• i. active internal bleeding, ii. bleeding at a non-compressible site, iii. bleeding diathesis within 30 days of PCI, iv. baseline platelet count \<90,000/μL, v. history of intracranial hemorrhage, vi. clinically significant gastrointestinal bleeding within 12 months of PCI, vii. baseline INR \> 1.5 in patients not prescribed VKA, suggesting underlying coagulation disorder.
• History of stroke
• Cardiogenic shock at the time of screening
• Ventricular arrhythmias refractory to treatment at the time of screening
• Calculated CrCl \<30 mL/min at the time of screening
• Known significant liver disease (e.g., acute hepatitis, chronic active hepatitis, cirrhosis), or liver function test (LFT) abnormalities at screening: alanine transaminase (ALT) \>5 times the upper limit of normal or ALT \>3 times the upper limit of normal plus total bilirubin \>2 times the upper limit of normal
• Hemoglobin level \<90 g/dL at screening
• Any severe condition that would limit life expectancy to less than 12 months
• Major surgery, biopsy of a parenchymal organ, or serious trauma within the past 30 days
• Incomplete staged PCI procedure (once completion of the staged PCI has occurred, the final PCI may become the index event)
• CABG planned
• Transient AF caused by a reversible disorder (e.g. thyrotoxicosis, pulmonary embolism, recent surgery)
• Any condition other than non-valvular AF requiring long-term anticoagulation with VKAs such as moderate to severe mitral valve stenosis, mechanical heart valves, deep vein thrombosis, pulmonary embolism, or left ventricular thrombus

Sponsors & Collaborators

• Ottawa Heart Institute Research Corporation: lead

Study Sites (1)

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Location

MeSH Terms

Conditions

Atrial Fibrillation; Acute Coronary Syndrome; Hemorrhage

Interventions

Ticagrelor; Rivaroxaban

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Myocardial Ischemia; Vascular Diseases

Intervention Hierarchy (Ancestors)

Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring

Study Officials

• Michel Le May, MD

  Ottawa Heart Institute Research Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2017
• First Posted: November 6, 2017
• Study Start: November 1, 2018
• Primary Completion: July 6, 2023
• Study Completion: July 6, 2023
• Last Updated: May 6, 2026

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)