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Tailoring P2Y12 Inhibiting Therapy in Patients Requiring Oral Anticoagulation After PCI (SWAP-AC-2)

Primary Purpose

Coronary Artery Disease

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ticagrelor 60mg
Clopidogrel
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring percutaneous coronary intervention, dual antiplatelet therapy, oral anticoagulant

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  • Age ≥ 18 years
  • Willing and able to provide written informed consent
  • Undergone successful PCI and treated with DAPT (aspirin plus a P2Y12 inhibitor) per standard of care
  • On treatment with a novel oral anticoagulant (apixaban, dabigatran, edoxaban, or rivaroxaban) for any indication (dosing regimen will be according to standard of care and at the discretion of the treating physician)

Exclusion criteria:

  • Any active bleeding or history of major bleeding
  • Ischemic Stroke within 1 month
  • Any history of hemorrhagic stroke, or intracranial hemorrhage
  • 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.
  • End-stage renal disease on hemodialysis
  • Known severe liver dysfunction or any known hepatic disease associated with coagulopathy
  • History of hypersensitivity or known contraindication to clopidogrel or ticagrelor.
  • 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

  • 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
  • Hemoglobin ≤9 mg/dL
  • Platelet count <80x106/mL

Sites / Locations

  • University of FloridaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Active Comparator

Arm Label

ABCD-GENE >10 - Clopidogrel

ABCD-GENE >10 - Ticagrelor

ABCD-GENE <10 - Clopidogrel

Arm Description

Patients with an ABCD-GENE>10 score will be randomized in a 1:1 fashion to ticagrelor (60 mg/bid) or clopidogrel (75 mg/qd). Treatment will be maintained for 30 days.

Patients with an ABCD-GENE>10 score will be randomized in a 1:1 fashion to ticagrelor (60 mg/bid) or clopidogrel (75 mg/qd). Treatment will be maintained for 30 days.

Patients with an ABCD-GENE<10 will be treated with clopidogrel (75 mg/qd) for 30 days.

Outcomes

Primary Outcome Measures

Platelet reactivity measured as PRU
The primary end point of our study will be levels of platelet reactivity, measured as P2Y12 reaction units (PRU) using the VerifyNow system of ticagrelor versus clopidogrel in patients with an ABCD-Gene score ≥10.

Secondary Outcome Measures

Full Information

First Posted
July 20, 2020
Last Updated
June 5, 2023
Sponsor
University of Florida
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1. Study Identification

Unique Protocol Identification Number
NCT04483583
Brief Title
Tailoring P2Y12 Inhibiting Therapy in Patients Requiring Oral Anticoagulation After PCI
Acronym
SWAP-AC-2
Official Title
Tailoring P2Y12 Inhibiting Therapy in Patients Requiring Oral Anticoagulation After Undergoing Percutaneous Coronary Intervention:The Switching Anti-Platelet and Anti-Coagulant Therapy (SWAP-AC) - 2 Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 8, 2020 (Actual)
Primary Completion Date
May 4, 2024 (Anticipated)
Study Completion Date
May 4, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida

4. Oversight

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.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Clopidogrel is the P2Y12 inhibitor of choice in PCI patients requiring OAC. However, concerns have been raised based on the notion that a considerable number of patients may have inadequate response to clopidogrel. Although practice recommendations indicate that the use of potent P2Y12 inhibitors (i.e., ticagrelor) may be considered in patients at increased thrombotic risk, they do not recommend routine testing to identify patients with poor response to clopidogrel. The aim of this study is to assess the pharmacodynamic effects of different P2Y12 inhibiting therapy (clopidogrel vs ticagrelor) in patients at high risk for high platelet reactivity identified according to the ABCD-GENE score in PCI treated patients also requiring OAC. Up to a total of up to 63 patients are planned to be prospectively enrolled in this investigation which will entail a series of comprehensive pharmacodynamic assessments to reach the study aim.
Detailed Description
The combination of aspirin plus a P2Y12 receptor inhibitor, also known as dual antiplatelet therapy (DAPT), is the cornerstone of treatment for patients with coronary artery disease (CAD) undergoing percutaneous coronary intervention (PCI). However, a considerable number of patients undergoing PCI also have an indication to be on treatment with an oral anticoagulant (OAC). It is estimated that 10-15% of PCI patients also have an indication to be on OAC, raising concerns on their optimal antithrombotic treatment regimen. Studies have consistently shown dropping aspirin and maintaining a P2Y12 inhibitor and OAC to be associated with reduces bleeding without any significant increase in ischemic events. Accordingly, current practice recommendations is to limit the use of aspirin to the peri-PCI period and maintain dual therapy with a P2Y12 inhibitor and an OAC. Clopidogrel is the P2Y12 inhibitor of choice in PCI patients requiring OAC. However, concerns have been raised based on the notion that a considerable number of patients may have inadequate response to clopidogrel, also known as high platelet reactivity (HPR) status, and thus be at risk for thrombotic complications. Although practice recommendations indicate that the use of potent P2Y12 inhibitors (i.e., ticagrelor) may be considered in patients at increased thrombotic risk, they do not recommend routine testing to identify patients with HPR status. Nevertheless, consensus recommendations do indicate that the selective use of tests to define HPR status is a reasonable option in selected cases such as PCI patients requiring OAC. The aim of this study is to assess the pharmacodynamic effects of different P2Y12 inhibiting therapy (clopidogrel vs ticagrelor) in patients at high risk for HPR identified according to the ABCD-GENE score in PCI treated patients also requiring OAC. Up to a total of up to 63 patients are planned to be prospectively enrolled in this investigation which will entail a series of comprehensive pharmacodynamic assessments to reach the study aim.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
percutaneous coronary intervention, dual antiplatelet therapy, oral anticoagulant

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ABCD-GENE >10 - Clopidogrel
Arm Type
Active Comparator
Arm Description
Patients with an ABCD-GENE>10 score will be randomized in a 1:1 fashion to ticagrelor (60 mg/bid) or clopidogrel (75 mg/qd). Treatment will be maintained for 30 days.
Arm Title
ABCD-GENE >10 - Ticagrelor
Arm Type
Experimental
Arm Description
Patients with an ABCD-GENE>10 score will be randomized in a 1:1 fashion to ticagrelor (60 mg/bid) or clopidogrel (75 mg/qd). Treatment will be maintained for 30 days.
Arm Title
ABCD-GENE <10 - Clopidogrel
Arm Type
Active Comparator
Arm Description
Patients with an ABCD-GENE<10 will be treated with clopidogrel (75 mg/qd) for 30 days.
Intervention Type
Drug
Intervention Name(s)
Ticagrelor 60mg
Other Intervention Name(s)
brilinta
Intervention Description
Patients will be administered a 180 mg loading dose followed by a 60 mg bid for the duration of the study.
Intervention Type
Drug
Intervention Name(s)
Clopidogrel
Other Intervention Name(s)
plavix
Intervention Description
Patients will be administered a 600 mg loading dose followed by a 75 mg daily for the duration of the study.
Primary Outcome Measure Information:
Title
Platelet reactivity measured as PRU
Description
The primary end point of our study will be levels of platelet reactivity, measured as P2Y12 reaction units (PRU) using the VerifyNow system of ticagrelor versus clopidogrel in patients with an ABCD-Gene score ≥10.
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Age ≥ 18 years Willing and able to provide written informed consent Undergone successful PCI and treated with DAPT (aspirin plus a P2Y12 inhibitor) per standard of care On treatment with a novel oral anticoagulant (apixaban, dabigatran, edoxaban, or rivaroxaban) for any indication (dosing regimen will be according to standard of care and at the discretion of the treating physician) Exclusion criteria: Any active bleeding or history of major bleeding Ischemic Stroke within 1 month Any history of hemorrhagic stroke, or intracranial hemorrhage 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. End-stage renal disease on hemodialysis Known severe liver dysfunction or any known hepatic disease associated with coagulopathy History of hypersensitivity or known contraindication to clopidogrel or ticagrelor. 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 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 Hemoglobin ≤9 mg/dL Platelet count <80x106/mL
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dominick J Angiolillo, MD, PhD
Phone
9042443378
Email
dominick.angiolillo@jax.ufl.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Francesco Franchi
Phone
904-244-2060
Email
francesco.franchi@jax.ufl.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dominick J Angiolillo, MD, PhD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dominick J Angiolillo, MD, PhD
Email
dominick.angiolillo@jax.ufl.edu
First Name & Middle Initial & Last Name & Degree
Dominick J Angiolillo, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Tailoring P2Y12 Inhibiting Therapy in Patients Requiring Oral Anticoagulation After PCI

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