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Switching From DAPT to Dual Pathway Inhibition With Low-dose Rivaroxaban in Adjunct to Aspirin in Patients With Coronary Artery Disease (SWAP-AC)

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ClinicalTrials.gov Identifier: NCT04006288
Recruitment Status : Recruiting
First Posted : July 5, 2019
Last Update Posted : September 10, 2019
Sponsor:
Collaborator:
Janssen, LP
Information provided by (Responsible Party):
University of Florida

Tracking Information
First Submitted Date  ICMJE June 25, 2019
First Posted Date  ICMJE July 5, 2019
Last Update Posted Date September 10, 2019
Actual Study Start Date  ICMJE September 6, 2019
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 1, 2019)
Maximal platelet aggregation (MPA%) by light transmittance aggregometry (LTA) [ Time Frame: 30 days ]
The primary end point of this study will be the comparison of MPA% measured by LTA using the CATF cocktail as agonist between DAPT and low-dose rivaroxaban plus aspirin for each DAPT regimen
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT04006288 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Switching From DAPT to Dual Pathway Inhibition With Low-dose Rivaroxaban in Adjunct to Aspirin in Patients With Coronary Artery Disease
Official Title  ICMJE Switching From Standard of Care Dual Antiplatelet Treatment (DAPT) Regimens With Aspirin Plus a P2Y12 Inhibitor to Dual Pathway Inhibition (DPI) With Low-dose Rivaroxaban in Adjunct to Aspirin in Patients With Coronary Artery Disease: The Switching Anti-Platelet and Anti-Coagulant Therapy (SWAP-AC) Study
Brief Summary Recent studies indicate that anti-factor-Xa inhibition with low-dose rivaroxaban may have a role in the reduction of ischemic recurrences in patients with atherosclerotic disease manifestations. The objectives of this investigation are to assess the feasibility of switching from a DAPT to DPI regimen and to compare the pharmacodynamic profiles of these treatment regimens. This will be a prospective study conducted in cohorts of patients with CAD on treatment per standard of care with DAPT. Patients will be randomized to either maintain DAPT or to DPI. DPI consists in treatment with aspirin (81mg/qd) plus rivaroxaban (2.5mg/bid).
Detailed Description Recent studies indicate that anti-factor-Xa inhibition with low-dose rivaroxaban may have a role in the reduction of ischemic recurrences in patients with atherosclerotic disease manifestations. In the COMPASS trial, patients with stable coronary or peripheral artery disease and no indication for oral anticoagulation or dual antiplatelet therapy (DAPT) were randomized to rivaroxaban 2.5 mg bid in combination with aspirin, rivaroxaban 5 mg bid monotherapy or aspirin monotherapy. The study showed a significant 24% relative reduction in ischemic outcomes with rivaroxaban 2.5 mg bid plus aspirin combination strategy compared with aspirin alone. These observations have raised practical considerations on how to implement the results of the COMPASS trial in clinical practice particularly for patients who are completing a minimum duration of DAPT and contemplating between continuing with a DAPT regimen versus switching to a dual pathway inhibition (DPI) regimen with aspirin plus rivaroxaban. Therefore, the objectives of this investigation are to assess the feasibility of switching from a DAPT to DPI regimen and to compare the pharmacodynamic profiles of these treatment regimens. This will be a prospective study conducted in cohorts of patients with CAD on treatment per standard of care with DAPT. Patients will be randomized to either maintain DAPT or to DPI. DPI consists in treatment with aspirin (81mg/qd) plus rivaroxaban (2.5mg/bid).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Patients treated with either aspirin (81mg/qd) plus clopidogrel, aspirin (81mg/qd) plus ticagrelor (90mg/bid), or aspirin (81mg/qd) plus prasugrel (10mg/bid) will be identified. Each cohort will be randomized 1:1 to either maintain DAPT or to DPI. DPI consists in treatment with aspirin (81mg/qd) plus rivaroxaban (2.5mg/bid). Patients randomized to DAPT will continue their guideline recommended DAPT regimens.
Masking: None (Open Label)
Masking Description:
laboratory personnel running pharmacodynamic testing will be blinded to treatment assignment.
Primary Purpose: Treatment
Condition  ICMJE Coronary Artery Disease
Intervention  ICMJE
  • Drug: Clopidogrel
    Patients on aspirin and plavix will be randomized to either continue with aspirin and plavix or to switch to aspirin and rivaroxaban
    Other Name: Plavix
  • Drug: Prasugrel
    Patients on aspirin and prasugrel will be randomized to either continue with aspirin and prasugrel or to switch to aspirin and rivaroxaban
    Other Name: Effient
  • Drug: ticagrelor
    Patients on aspirin and ticagrelor will be randomized to either continue with aspirin and ticagrelor or to switch to aspirin and rivaroxaban
    Other Name: brilinta
  • Drug: aspirin
    all patients will remain on aspirin
  • Drug: rivaroxaban
    Patients on DAPT will be randomized to either continue with DAPT or to switch to aspirin and rivaroxaban
    Other Name: xarelto
Study Arms  ICMJE
  • Active Comparator: Aspirin and clopidogrel
    aspirin 81 mg/qd plus clopidogrel 75mg/qd for 30 days
    Interventions:
    • Drug: Clopidogrel
    • Drug: aspirin
  • Experimental: Aspirin and rivaroxaban from aspirin and clopidogrel
    aspirin 81mg/qd plus rivaroxaban 2.5mg/bid for 30 days
    Interventions:
    • Drug: aspirin
    • Drug: rivaroxaban
  • Active Comparator: Aspirin and prasugrel
    aspirin 81 mg/qd plus prasugrel 10mg/qd for 30 days
    Interventions:
    • Drug: Prasugrel
    • Drug: aspirin
  • Experimental: Aspirin and rivaroxaban from aspirin and prasugrel
    aspirin 81mg/qd plus rivaroxaban 2.5mg/bid for 30 days
    Interventions:
    • Drug: aspirin
    • Drug: rivaroxaban
  • Active Comparator: Aspirin and ticagrelor
    aspirin 81 mg/qd plus ticagrelor 60mg/bid for 30 days
    Interventions:
    • Drug: ticagrelor
    • Drug: aspirin
  • Experimental: Aspirin and rivaroxaban from aspirin and ticagrelor
    aspirin 81mg/qd plus rivaroxaban 2.5mg/bid for 30 days
    Interventions:
    • Drug: aspirin
    • Drug: rivaroxaban
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 1, 2019)
90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2021
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

  • Willing and able to provide written informed consent
  • Above 18 years of age
  • Have known CAD and have completed their required duration of standard of care DAPT (aspirin in combination with either clopidogrel, prasugrel, or ticagrelor) and still be on treatment:

    • ≥ 6 months after an elective PCI
    • ≥ 12 months after experiencing an ACS (irrespective of revascularization at the time of ACS; thus patients treated by PCI, CABG, or medically managed can be considered)

Exclusion criteria:

  • Deemed to be at high risk of bleeding, active bleeding or history of major bleeding Stroke within 1 month or any history of hemorrhagic or lacunar stroke
  • Estimated glomerular filtration rate <15 mL/min by MDRD equation
  • Need for dual antiplatelet therapy, other non-aspirin antiplatelet therapy, or oral anticoagulant therapy
  • Known non-cardiovascular disease that is associated with poor prognosis (e.g., metastatic cancer) or that increases the risk of an adverse reaction to study interventions.
  • History of hypersensitivity or known contraindication for rivaroxaban.
  • Systemic treatment with strong inhibitors of both CYP 3A4 and p-glycoprotein (e.g., systemic azole antimycotics, such as ketoconazole, and human immunodeficiency virus [HIV]-protease inhibitors, such as ritonavir), or strong inducers of CYP 3A4, i.e.

rifampicin, rifabutin, phenobarbital, phenytoin, and carbamazepine

  • Any known hepatic disease associated with coagulopathy
  • Subjects who are pregnant, breastfeeding, or are of childbearing potential, and sexually active and not practicing an effective method of birth control (e.g. surgically sterile, prescription oral contraceptives, contraceptive injections, intrauterine device, double barrier method, contraceptive patch, male partner sterilization)
  • Concomitant participation in another study with investigational drug
  • Known contraindication to any study related procedures
  • Hemoglobin ≤9 mg/dL
  • Platelet count <80x106/mL
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Dominick J Angiolillo, MD, PhD 9042443378 dominick.angiolillo@jax.ufl.edu
Contact: Andrea Goosen, RN 9042445617 andrea.goosen@jax.ufl.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04006288
Other Study ID Numbers  ICMJE IIS-RIVA02
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Florida
Study Sponsor  ICMJE University of Florida
Collaborators  ICMJE Janssen, LP
Investigators  ICMJE
Principal Investigator: Dominick J Angiolillo, MD, PhD University of Florida
PRS Account University of Florida
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP