Tailoring P2Y12 Inhibiting Therapy in Patients Requiring Oral Anticoagulation After PCI

NCT04483583 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: IRB202001360
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

percutaneous coronary intervention; dual antiplatelet therapy; oral anticoagulant

Outcome Measures

Primary Outcomes (1)

• 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. A PRU \>208 suggests high platelet reactivity, while \<85 may indicate increased bleeding risk.

  30 days

Study Arms (3)

ABCD-GENE >10 - Clopidogrel

ACTIVE COMPARATOR

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.

Drug: Clopidogrel

ABCD-GENE >10 - Ticagrelor

EXPERIMENTAL

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.

Drug: Ticagrelor 60mg

ABCD-GENE <10 - Clopidogrel

ACTIVE COMPARATOR

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

Drug: Clopidogrel

Interventions

Ticagrelor 60mg DRUG

Patients will be administered a 180 mg loading dose followed by a 60 mg bid for the duration of the study.

Also known as: brilinta

ABCD-GENE >10 - Ticagrelor

Clopidogrel DRUG

Patients will be administered a 600 mg loading dose followed by a 75 mg daily for the duration of the study.

Also known as: plavix

ABCD-GENE <10 - Clopidogrel; ABCD-GENE >10 - Clopidogrel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida

Jacksonville, Florida, 32209, United States

Location

Related Publications (1)

• Ortega-Paz L, Bor W, Franchi F, van den Broek WWA, Rollini F, Giordano S, Galli M, Been L, Ghanem G, Shalhoub A, Garabedian H, Al Saleh T, Uzunoglu E, Zhou X, Rivas A, Pineda AM, Suryadevara S, Soffer D, Mahowald MK, Choi CY, Zenni MM, Phoenix F, Ajjan RA, Ten Berg JM, Angiolillo DJ. P2Y12 Inhibition in Patients Requiring Oral Anticoagulation After Percutaneous Coronary Intervention: The SWAP-AC-2 Study. JACC Cardiovasc Interv. 2024 Jun 10;17(11):1356-1370. doi: 10.1016/j.jcin.2024.03.027. Epub 2024 Apr 7.

  PMID: 38597172 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Ticagrelor; Clopidogrel

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring

Limitations and Caveats

Small sample size

Results Point of Contact

• Title: Dominick J Angiolillo
• Organization: University of Florida

dominick.angiolillo@jax.ufl.edu

904-244-2636

Study Officials

• Dominick J Angiolillo, MD, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2020
• First Posted: July 23, 2020
• Study Start: December 8, 2020
• Primary Completion: January 7, 2025
• Study Completion: January 7, 2025
• Last Updated: July 31, 2025
• Results First Posted: July 31, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)