Comparison of Dual Antiplatelet Therapy De-escalation by Dose Reduction Versus Switching in Patients Undergoing PCI: The Switching Antiplatelet-8 (SWAP-8) Study

NCT06821191 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: IRB202401735
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

Dual antiplatelet therapy (DAPT) with low-dose aspirin and a P2Y12 inhibitor is the current standard of care in patients with coronary artery disease experiencing an acute event or undergoing percutaneous coronary intervention. However, the ischemic benefits are counterbalanced by a significant increase in bleeding events. Over time, different DAPT de-escalation strategies have been developed to reduce the bleeding risk while maintaining the ischemic protection, but there is currently no head-to-head comparison between them. The purpose of this clinical trial is to conduct a head-to-head comparison on the pharmacodynamic efficacy of DAPT de-escalation by dose reduction to low-dose prasugrel (5 mg od) and DAPT de-escation by switching from standard-dose more potent P2Y12 receptor inhibitor to standard-dose clopidogrel (75 mg). To determine if the PD profiles of these two strategies are comparable, we aim to conduct a non-inferiority study.

Conditions

Coronary Artery Disease

Keywords

Coronary artery disease; DAPT de-escalation; DAPT; dose-reduction; switch; clopidogrel; prasugrel

Outcome Measures

Primary Outcomes (1)

• Platelet reactivity measured by VerifyNow

  The primary endpoint of the study will be to establish non-inferiority by comparing PRU levels, determined using the VerifyNow system, between de-escalation through dose reduction to low-dose prasugrel (5 mg qd) and de-escalation through switching to standard-dose clopidogrel (75 mg qd) at trough levels.

  30±5 days

Secondary Outcomes (1)

• Platelet reactivity measured by VerifyNow

  30±5 days

Study Arms (2)

DAPT de-escalation by switch

ACTIVE COMPARATOR

Drug: clopidogrel 75 mg

DAPT de-escalation by dose-reduction

EXPERIMENTAL

Drug: Prasugrel 5 mg

Interventions

clopidogrel 75 mg DRUG

Clopidogrel 75 mg od for 30 ± 5 days

DAPT de-escalation by switch

Prasugrel 5 mg DRUG

Prasugrel 5 mg od for 30 ± 5 days

DAPT de-escalation by dose-reduction

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, consisting of low-dose aspirin with either prasugrel (10 mg qd) or ticagrelor (90 mg bid) as part of standard of care. 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
• Prior cerebrovascular event
• PCI within 30 days
• Predicted poor metabolizer of clopidogrel based on CYP2C19 genotyping (e.g., \*2/\*2 or \*3/\*3),
• 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 Aspirin, Clopidogrel, or Prasugrel
• Known hematologic malignancies or thrombocytopenia (platelet count \<80x106/mL)
• Known hemoglobinopathies or anemia (hemoglobin \<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 (3)

• Erlinge D, Ten Berg J, Foley D, Angiolillo DJ, Wagner H, Brown PB, Zhou C, Luo J, Jakubowski JA, Moser B, Small DS, Bergmeijer T, James S, Winters KJ. Reduction in platelet reactivity with prasugrel 5 mg in low-body-weight patients is noninferior to prasugrel 10 mg in higher-body-weight patients: results from the FEATHER trial. J Am Coll Cardiol. 2012 Nov 13;60(20):2032-40. doi: 10.1016/j.jacc.2012.08.964. Epub 2012 Oct 17.

  PMID: 23083774 BACKGROUND

• Erlinge D, Gurbel PA, James S, Lindahl TL, Svensson P, Ten Berg JM, Foley DP, Wagner H, Brown PB, Luo J, Zhou C, Moser BA, Jakubowski JA, Small DS, Winters KJ, Angiolillo DJ. Prasugrel 5 mg in the very elderly attenuates platelet inhibition but maintains noninferiority to prasugrel 10 mg in nonelderly patients: the GENERATIONS trial, a pharmacodynamic and pharmacokinetic study in stable coronary artery disease patients. J Am Coll Cardiol. 2013 Aug 13;62(7):577-83. doi: 10.1016/j.jacc.2013.05.023. Epub 2013 Jun 7.

  PMID: 23747759 BACKGROUND

• Capodanno D, Mehran R, Krucoff MW, Baber U, Bhatt DL, Capranzano P, Collet JP, Cuisset T, De Luca G, De Luca L, Farb A, Franchi F, Gibson CM, Hahn JY, Hong MK, James S, Kastrati A, Kimura T, Lemos PA, Lopes RD, Magee A, Matsumura R, Mochizuki S, O'Donoghue ML, Pereira NL, Rao SV, Rollini F, Shirai Y, Sibbing D, Smits PC, Steg PG, Storey RF, Ten Berg J, Valgimigli M, Vranckx P, Watanabe H, Windecker S, Serruys PW, Yeh RW, Morice MC, Angiolillo DJ. Defining Strategies of Modulation of Antiplatelet Therapy in Patients With Coronary Artery Disease: A Consensus Document from the Academic Research Consortium. Circulation. 2023 Jun 20;147(25):1933-1944. doi: 10.1161/CIRCULATIONAHA.123.064473. Epub 2023 Jun 19.

  PMID: 37335828 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Clopidogrel; Prasugrel Hydrochloride

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Piperazines

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: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The proposed investigation will be a prospective, randomized, parallel-design, open-label study.

Study Record Dates

• First Submitted: February 6, 2025
• First Posted: February 11, 2025
• Study Start: March 10, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): January 7, 2027
• Last Updated: April 15, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)