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The Safety and Efficacy Of Rivaroxaban and Ticagrelor for Patients With Atrial Fibrillation After Percutaneous Coronary Intervention (CAPITAL PCI AF)

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ClinicalTrials.gov Identifier: NCT03331484
Recruitment Status : Recruiting
First Posted : November 6, 2017
Last Update Posted : November 9, 2018
Sponsor:
Information provided by (Responsible Party):
Ottawa Heart Institute Research Corporation

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.


Condition or disease Intervention/treatment Phase
Atrial Fibrillation Acute Coronary Syndrome Drug: Ticagrelor Drug: Rivaroxaban Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 190 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: THE CAPITAL PCI AF Study: The Safety and Efficacy of Rivaroxaban and Ticagrelor for Patients With Atrial Fibrillation After Percutaneous Coronary Intervention
Actual Study Start Date : November 1, 2018
Estimated Primary Completion Date : November 1, 2020
Estimated Study Completion Date : December 15, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Ticagrelor and Rivaroxaban
All participants will be prescribed ticagrelor 90 mg twice daily and rivaroxaban 15 mg once daily for a year.
Drug: Ticagrelor
Ticagrelor 90 mg twice daily

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




Primary Outcome Measures :
  1. Composite of TIMI Bleeds [ Time Frame: 12 months ]
    Composite of TIMI Major Bleed, Minor Bleed, and Bleeding requiring medical attention


Secondary Outcome Measures :
  1. The frequency of the individual components of the primary endpoint [ Time Frame: 12 months ]
    Frequency of TIMI major, TIMI Minor, and TIMI bleeding requiring medical attention

  2. The composite of multiple adverse cardiovascular events (MACE) [ Time Frame: 12 months ]
    The composite of cardiovascular death and stroke events and its individual components

  3. The frequency of stent thrombosis [ Time Frame: 12 months ]
  4. All-cause mortality [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient has undergone a PCI with stent placement, plus
  2. 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.

Exclusion Criteria:

  1. Age <18 years old
  2. 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.

  3. History of stroke
  4. Cardiogenic shock at the time of screening
  5. Ventricular arrhythmias refractory to treatment at the time of screening
  6. Calculated CrCl <30 mL/min at the time of screening
  7. 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
  8. Hemoglobin level <90 g/dL at screening
  9. Any severe condition that would limit life expectancy to less than 12 months
  10. Major surgery, biopsy of a parenchymal organ, or serious trauma within the past 30 days
  11. Incomplete staged PCI procedure (once completion of the staged PCI has occurred, the final PCI may become the index event)
  12. CABG planned
  13. Transient AF caused by a reversible disorder (e.g. thyrotoxicosis, pulmonary embolism, recent surgery)
  14. 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
  15. Known allergies, hypersensitivity, or intolerance to rivaroxaban or ticagrelor
  16. Pregnant or planning to become pregnant while enrolled in this study, or unwilling to employ an investigator-approved method of birth control
  17. Participation in a study with another investigational device or drug < four weeks
  18. Is receiving systemic treatment with strong inhibitors of both cytochrome P450 (CYP) 3A4 and p-glycoprotein (P-gp; eg, the azole-antimycotic ketoconazole and the HIV-protease inhibitor ritonavir). Treatment with fluconazole is allowed.
  19. CHADS-VASC <1

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03331484


Contacts
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Contact: Michel Le May, MD 613-696-7297 mlemay@ottawaheart.ca
Contact: Savannah Harrison-Hayman, B.A. (Hons) 613-696-7297 sharrison-hayman@ottawaheart.ca

Locations
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Canada, Ontario
University of Ottawa Heart Institute Recruiting
Ottawa, Ontario, Canada, K1Y 4W7
Contact: Michel Le May, MD    613-696-7297    mlemay@ottawaheart.ca   
Contact: Savannah Harrison-Hayman, B.A. (Hons)    613-696-7297    sharrison-hayman@ottawaheart.ca   
Principal Investigator: Michel Le May, MD         
Sponsors and Collaborators
Ottawa Heart Institute Research Corporation
Investigators
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Principal Investigator: Michel Le May, MD Ottawa Heart Institute Research Corporation

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Responsible Party: Ottawa Heart Institute Research Corporation
ClinicalTrials.gov Identifier: NCT03331484     History of Changes
Other Study ID Numbers: MRL-PCI AF
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: November 9, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Ottawa Heart Institute Research Corporation:
percutaneous coronary intervention
bleeding
atrial fibrillation
Ticagrelor
Rivaroxaban

Additional relevant MeSH terms:
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Atrial Fibrillation
Acute Coronary Syndrome
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Myocardial Ischemia
Vascular Diseases
Ticagrelor
Rivaroxaban
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Anticoagulants