Recruiting

Potent P2Y12 Inhibitors

Sponsor:

University of Florida

Code:

NCT06691191

Conditions

Coronary Artery Disease

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Ticagrelor 90 mg

Prasugrel 10 mg

Study Details

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

Study ID

NCT06691191

Start date

Jan 8, 2025

Status verified date

Feb, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Aug 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion criteria:

1. 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.
2. Age between 18 and 75 years old
3. Able to provide written informed consent

Exclusion criteria:

1. Prior history of stent thrombosis
2. PCI within 90 days.
3. History of stroke/TIA
4. Age > 75 years old
5. Weight < 60 kg
6. History of intracranial hemorrhage
7. On treatment with any oral anticoagulant or chronic low-molecular-weight heparin (at venous thrombosis treatment, not for prophylaxis)
8. Patients with known coagulation disorders
9. Known severe hepatic impairment
10. Hypersensitivity to prasugrel or ticagrelor
11. 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.

Study Design

Enrollment

48 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

Ticagrelor 90 mg

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

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Francesco Franchi, MD

9042445515francesco.franchi@jax.ufl.edu

Andrea Burton

(904) 244-5617andrea.burton@jax.ufl.edu

Locations

University of Florida Jacksonville

Recruiting

Jacksonville, Florida, United States, 32209

More Information

Sponsor

University of Florida

Last update posted

Feb 5, 2026

Last verified

Feb, 2026

Keywords

  • percutaneous coronary intervention
  • ticagrelor
  • prasugrel
  • bleeding
  • platelets

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Florida on 2026-02-05.