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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 3, 2019
Last Update Posted : September 10, 2019
Sponsor:
Collaborator:
Janssen, LP
Information provided by (Responsible Party):
University of Florida

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).

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Drug: Clopidogrel Drug: Prasugrel Drug: ticagrelor Drug: aspirin Drug: rivaroxaban Phase 4

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
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
Official Title: 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
Actual Study Start Date : September 6, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Aspirin and clopidogrel
aspirin 81 mg/qd plus clopidogrel 75mg/qd for 30 days
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: aspirin
all patients will remain on aspirin

Experimental: Aspirin and rivaroxaban from aspirin and clopidogrel
aspirin 81mg/qd plus rivaroxaban 2.5mg/bid for 30 days
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

Active Comparator: Aspirin and prasugrel
aspirin 81 mg/qd plus prasugrel 10mg/qd for 30 days
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: aspirin
all patients will remain on aspirin

Experimental: Aspirin and rivaroxaban from aspirin and prasugrel
aspirin 81mg/qd plus rivaroxaban 2.5mg/bid for 30 days
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

Active Comparator: Aspirin and ticagrelor
aspirin 81 mg/qd plus ticagrelor 60mg/bid for 30 days
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

Experimental: Aspirin and rivaroxaban from aspirin and ticagrelor
aspirin 81mg/qd plus rivaroxaban 2.5mg/bid for 30 days
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




Primary Outcome Measures :
  1. 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



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:

  • 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

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): NCT04006288


Contacts
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Contact: Dominick J Angiolillo, MD, PhD 9042443378 dominick.angiolillo@jax.ufl.edu
Contact: Andrea Goosen, RN 9042445617 andrea.goosen@jax.ufl.edu

Locations
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United States, Florida
University of Florida Recruiting
Jacksonville, Florida, United States, 32209
Contact: Dominick J Angiolillo, MD, PhD       dominick.angiolillo@jax.ufl.edu   
Principal Investigator: Dominick J Angiolillo, MD, PhD         
Sponsors and Collaborators
University of Florida
Janssen, LP
Investigators
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Principal Investigator: Dominick J Angiolillo, MD, PhD University of Florida

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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT04006288     History of Changes
Other Study ID Numbers: IIS-RIVA02
First Posted: July 3, 2019    Key Record Dates
Last Update Posted: September 10, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by University of Florida:
dual antiplatelet therapy
rivaroxaban
pharmacodynamic
Additional relevant MeSH terms:
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Myocardial Ischemia
Aspirin
Clopidogrel
Coronary Artery Disease
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Rivaroxaban
Ticagrelor
Prasugrel Hydrochloride
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists