The Switching Antiplatelet-9 (SWAP-9) Study

NCT06588595 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: IRB202400929
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the pharmacodynamic effects of ABCD-GENE guided vs. unguided de-escalation strategies among patients on dual antiplatelet therapy (DAPT) following percutaneous coronary intervention (PCI).

Conditions

Coronary Arterial Disease (CAD)

Keywords

ABCD-GENE score; Dual antiplatelet therapy (DAPT); Pharmacodynamic (PD) study; Percutaneous coronary intervention (PCI); P2Y12 receptor inhibitor

Outcome Measures

Primary Outcomes (1)

• P2Y12 Reaction Units (PRU)

  Comparison of PRU determined by VerifyNow between ABCD-GENE-guided de-escalation vs. unguided de-escalation.

  At 30±5 days (trough levels)

Secondary Outcomes (1)

• P2Y12 Reaction Units (PRU)

  At 30±5 days (trough levels)

Study Arms (2)

ABCD-GENE-guided de-escalation

EXPERIMENTAL

ABCD-GENE ≥10: prasugrel 10 mg qd or ticagrelor 90 mg od monotherapy. ABCD-GENE \<10: Aspirin 81 mg qd and clopidogrel 75 mg qd.

Drug: Prasugrel/Ticagrelor monotherapy or aspirin plus clopidogrel

Unguided de-escalation

ACTIVE COMPARATOR

Aspirin 81 mg qd and clopidogrel 75 mg qd.

Drug: Aspirin plus clopidogrel

Interventions

Prasugrel/Ticagrelor monotherapy or aspirin plus clopidogrel DRUG

After at least 30 days of DAPT \[with aspirin 81-mg qd and a potent P2Y12 inhibitor (prasugrel 10 mg qd or ticagrelor 90-mg BID)\] in chronic coronary syndrome or after at least 90 days of DAPT in acute coronary syndromes; patients with an ABCD-GENE 10 or more will continue prasugrel 10 mg qd/ticagrelor 90 mg BID and drop aspirin; and patients with an ABCD-GENE less than10 will switch from prasugrel/ticagrelor-based DAPT to aspirin 81 mg qd plus clopidogrel 75 mg qd.

ABCD-GENE-guided de-escalation

Aspirin plus clopidogrel DRUG

After at least 30 days of DAPT \[with aspirin 81 mg qd and a potent P2Y12 inhibitor (prasugrel 10 mg qd or ticagrelor 90 mg BID)\] in chronic coronary syndrome or after at least 90 days of DAPT in acute coronary syndromes; patients will switch from prasugrel/ticagrelor-based DAPT to aspirin 81 mg qd plus clopidogrel 75 mg qd, irrespective of ABCD-GENE score.

Unguided de-escalation

Eligibility Criteria

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

You may qualify if:

• Patients who have undergone PCI and are on maintenance treatment with DAPT, composed of low-dose aspirin (81mg qd) with either prasugrel (10 mg qd) or ticagrelor (90 mg bid). In particular, patients who underwent PCI in the setting of an acute coronary syndrome will be eligible for randomization after ≥90 days post-PCI, while patients who underwent PCI in the setting of a chronic coronary syndrome ≥30 days post-PCI.
• Age ≥18 years
• Provide written informed consent.

You may not qualify if:

• Prior history of stent thrombosis
• PCI within 30 days
• On treatment with any oral anticoagulant (vitamin K antagonists, dabigatran, rivaroxaban, apixaban, edoxaban) or chronic low-molecular-weight heparin (at venous thrombosis treatment, not for prophylaxis)
• Hemodynamic instability
• Hypersensitivity to clopidogrel
• Known platelet count less than 80x10\^6/mL
• Known hemoglobin less than 9 g/dL
• Pregnant and breastfeeding women \[women of childbearing age must use reliable birth control (i.e., oral contraceptives) while participating in the study\].

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida

Jacksonville, Florida, 32209, United States

RECRUITING

Related Publications (2)

• Angiolillo DJ, Capodanno D, Danchin N, Simon T, Bergmeijer TO, Ten Berg JM, Sibbing D, Price MJ. Derivation, Validation, and Prognostic Utility of a Prediction Rule for Nonresponse to Clopidogrel: The ABCD-GENE Score. JACC Cardiovasc Interv. 2020 Mar 9;13(5):606-617. doi: 10.1016/j.jcin.2020.01.226.

  PMID: 32139218 BACKGROUND

• Capodanno D, Baber U, Bhatt DL, Collet JP, Dangas G, Franchi F, Gibson CM, Gwon HC, Kastrati A, Kimura T, Lemos PA, Lopes RD, Mehran R, O'Donoghue ML, Rao SV, Rollini F, Serruys PW, Steg PG, Storey RF, Valgimigli M, Vranckx P, Watanabe H, Windecker S, Angiolillo DJ. P2Y12 inhibitor monotherapy in patients undergoing percutaneous coronary intervention. Nat Rev Cardiol. 2022 Dec;19(12):829-844. doi: 10.1038/s41569-022-00725-6. Epub 2022 Jun 13.

  PMID: 35697777 BACKGROUND

MeSH Terms

Interventions

Prasugrel Hydrochloride; Aspirin; Clopidogrel

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Ticlopidine; Thienopyridines; Pyridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Luis Ortega, MD, PhD

CONTACT

904-244 2060; Luis.Ortega@jax.ufl.edu

Andrea Burton, MPH, CCRP

CONTACT

904-244-5617; Andrea.Burton@jax.ufl.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Laboratory personnel processing blood samples will be blinded to the allocation of the participants.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2024
• First Posted: September 19, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): February 28, 2027
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)