Switching From Dual Antiplatelet Therapy to Monotherapy With Potent P2Y12 Inhibitors

Part of paid clinical trials in Jacksonville, Florida.

Sponsor
University of Florida
Study ID
NCT06691191
Phase
PHASE4
Status
Recruiting
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Conditions

  • Coronary Artery Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
Jan 8, 2025
Status verified
Feb 2026
Primary completion
Aug 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
48 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Ticagrelor monotherapy
    Ticagrelor 90 mg bid monotherapy for 21±7 days
  • Experimental: Prasugrel monotherapy
    Prasugrel 10 mg qd for 21±7 days

Primary Outcome Measure

Platelet reactivity measured by VerifyNow [ Time Frame: 21±7 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Florida JacksonvilleJacksonvilleFlorida32209
Francesco Franchi, MD

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University of Florida Jacksonville· Jacksonville, FL

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