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

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 |
- 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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
- Willing and able to provide written informed consent
- Above 18 years of age
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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

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
Contact: Dominick J Angiolillo, MD, PhD | 9042443378 | dominick.angiolillo@jax.ufl.edu | |
Contact: Andrea Goosen, RN | 9042445617 | andrea.goosen@jax.ufl.edu |
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 |
Principal Investigator: | Dominick J Angiolillo, MD, PhD | University of Florida |
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 |
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 |
dual antiplatelet therapy rivaroxaban pharmacodynamic |
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 |