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出境医 / 临床实验 / Switching From DAPT to Dual Pathway Inhibition With Low-dose Rivaroxaban in Adjunct to Aspirin in Patients With Coronary Artery Disease (SWAP-AC)
Switching From DAPT to Dual Pathway Inhibition With Low-dose Rivaroxaban in Adjunct to Aspirin in Patients With Coronary Artery Disease (SWAP-AC)
Study Description
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).
Study Design
| 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 : | July 2021 |
| Estimated Study Completion Date : | December 2021 |
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures :
- 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
Eligibility Criteria
| 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
Contacts and Locations
Contacts
| Contact: Dominick J Angiolillo, MD, PhD | 9042443378 | dominick.angiolillo@jax.ufl.edu | |
| Contact: Andrea Goosen, RN | 9042445617 | andrea.goosen@jax.ufl.edu |
Locations
| 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
| Principal Investigator: | Dominick J Angiolillo, MD, PhD | University of Florida |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | June 25, 2019 | ||||||||
| First Posted Date ICMJE | July 5, 2019 | ||||||||
| Last Update Posted Date | November 4, 2020 | ||||||||
| Actual Study Start Date ICMJE | September 6, 2019 | ||||||||
| Estimated Primary Completion Date | July 2021 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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 | |||||||||
| 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 |
|
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| Study Arms ICMJE |
|
||||||||
| 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 |
90 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | December 2021 | ||||||||
| Estimated Primary Completion Date | July 2021 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion criteria:
Exclusion criteria:
rifampicin, rifabutin, phenobarbital, phenytoin, and carbamazepine
|
||||||||
| Sex/Gender ICMJE |
|
||||||||
| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
|
||||||||
| 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 |
|
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| IPD Sharing Statement ICMJE |
|
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| Responsible Party | University of Florida | ||||||||
| Study Sponsor ICMJE | University of Florida | ||||||||
| Collaborators ICMJE | Janssen, LP | ||||||||
| Investigators ICMJE |
|
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| PRS Account | University of Florida | ||||||||
| Verification Date | November 2020 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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