Switching From Dual Antiplatelet Therapy to Monotherapy With Potent P2Y12 Inhibitors

NCT06691191 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: IRB202401578
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

Ticagrelor currently represents the most tested and commonly used P2Y12 inhibitor monotherapy following percutaneous coronary intervention. The purpose of this study is to conduct a head-to-head comparison on the pharmacodynamic efficacy of ticagrelor-based and prasugrel-based single antiplatelet therapy. To determine if the PD profiles of ticagrelor- and prasugrel-based SAPT are comparable, we aim to conduct a non-inferiority study between the two strategies.

Conditions

Coronary Artery Disease

Keywords

percutaneous coronary intervention; ticagrelor; prasugrel; bleeding; platelets

Outcome Measures

Primary Outcomes (1)

• Platelet reactivity measured by VerifyNow

  The primary endpoint of the study is the comparison of P2Y12 reaction unites (PRU) levels determined by VerifyNow between prasugrel monotherapy and ticagrelor monotherapy

  21±7 days

Study Arms (2)

Ticagrelor monotherapy

ACTIVE COMPARATOR

Ticagrelor 90 mg bid monotherapy for 21±7 days

Drug: Ticagrelor 90 mg

Prasugrel monotherapy

EXPERIMENTAL

Prasugrel 10 mg qd for 21±7 days

Drug: Prasugrel 10 mg

Interventions

Ticagrelor 90 mg DRUG

After providing written informed consent, patients on DAPT meeting study entry criteria will stop aspirin and be randomly assigned in a 1:1 fashion using a computer-based randomization system to either: a) ticagrelor 90 mg bid monotherapy or b) prasugrel 10 mg qd monotherapy. Patients will continue the randomized treatment for 21±7 days.

Also known as: Brilinta

Ticagrelor monotherapy

Prasugrel 10 mg DRUG

After providing written informed consent, patients on DAPT meeting study entry criteria will stop aspirin and be randomly assigned in a 1:1 fashion using a computer-based randomization system to either: a) ticagrelor 90 mg bid monotherapy or b) prasugrel 10 mg qd monotherapy. Patients will continue the randomized treatment for 21±7 days.

Also known as: Effient

Prasugrel monotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients on DAPT with aspirin plus prasugrel 10 mg or ticagrelor 90 mg bid as per standard of care at least 90 days after PCI.
• Age between 18 and 75 years old
• Able to provide written informed consent

You may not qualify if:

• Prior history of stent thrombosis
• PCI within 90 days.
• History of stroke/TIA
• Age \> 75 years old
• Weight \< 60 kg
• History of intracranial hemorrhage
• On treatment with any oral anticoagulant or chronic low-molecular-weight heparin (at venous thrombosis treatment, not for prophylaxis)
• Patients with known coagulation disorders
• Known severe hepatic impairment
• Hypersensitivity to prasugrel or ticagrelor
• Pregnant and breastfeeding persons \[persons of childbearing age must use reliable birth control (i.e., oral contraceptives) while participating in the study\]. If the potential subject is a person of childbearing potential, a pregnancy test will be done. If the subject is pregnant, participation in this study will end.

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida Jacksonville

Jacksonville, Florida, 32209, United States

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease; Hemorrhage

Interventions

Ticagrelor; Prasugrel Hydrochloride

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

• Francesco Franchi, MD

  University of Florida College of Medicine Jacksonville

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francesco Franchi, MD

CONTACT

9042445515; francesco.franchi@jax.ufl.edu

Andrea Burton

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: November 14, 2024
• First Posted: November 15, 2024
• Study Start: January 8, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)