Recruiting

Bleeding ReductionTailoring Bleeding Reduction Approaches in Patients Undergoing PCI

Sponsor:

University of Florida

Code:

NCT05681702

Conditions

Coronary Artery Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

aspirin plus clopidogrel

prasugrel or ticagrelor

Study Details

Brief summary:

Two strategies have both proven to be effective in reducing bleeding complications while preserving efficacy compared with maintaining long-term DAPT with aspirin and a potent P2Y12 inhibitor: a) DAPT de-escalation (i.e., switching from prasugrel or ticagrelor to clopidogrel while maintaining aspirin) and b) potent P2Y12 inhibitor monotherapy (i.e., maintaining prasugrel or ticagrelor and dropping aspirin). These strategies have been tested in a number of trials and have led to changes in practice guidelines to consider either one of these strategies as bleeding reduction approaches among ACS patients undergoing PCI. However, comparative assessments between DAPT de-escalation and potent P2Y12 inhibitor monotherapy are lacking.

Conditions

Coronary Artery Disease

Study ID

NCT05681702

Start date

Feb 15, 2023

Status verified date

Mar, 2026

Completion date

Mar 31, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Patients who presented with chronic coronary syndrome, underwent PCI and have been on maintenance treatment with DAPT, composed of low-dose aspirin (81mg od) and prasugrel (10 mg od) or ticagrelor (90 mg bid) for at least 30 days. Or patients that presented with an Acute coronary syndrome (ACS) event and underwent PCI and have been on maintenance treatment with DAPT, composed of low-dose aspirin (81mg od) and prasugrel (10mg od) or ticagrelor (90mg bid) for 3 months or greater.
2. Age ≥18 years old
3. Provide written informed consent

Exclusion Criteria:

1. Prior history of stent thrombosis
2. 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)
3. Renal failure requiring dialysis
4. Patients with known bleeding diathesis or coagulation disorders
5. Known severe hepatic impairment
6. Hemodynamic instability
7. Hypersensitivity to clopidogrel
8. Pregnant and breastfeeding women \[women of childbearing age must use reliable birth control (i.e., oral contraceptives) while participating in the study\]

Study Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: DAPT de-escalation

Aspirin 81-mg od and clopidogrel 75-mg qd.

experimental: Potent P2Y12 monotherapy

Potent P2Y12 inhibitor with prasugrel 10 mg od or ticagrelor 90 mg BID.

Interventions

aspirin plus clopidogrel

After at least 30 days of DAPT \[with aspirin 81-mg od and a potent P2Y12 inhibitor (prasugrel 10 mg od or ticagrelor 90-mg BID)\] in chronic coronary syndrome or after at least 90 days of DAPT in acute coronary syndromes; patients will continue aspirin and switch to clopidogrel 75-mg.

prasugrel or ticagrelor

Primary outcome measure

Thrombus formation defined as AUC measured by T-TAS [ Time Frame: 30 days ]

Central Contacts and Locations

Central contacts

Dominick J Angiolillo, MD,PhD

+1-904-244-3378 dominick.angiolillo@jax.ufl.edu

Andrea Burton, MPH, CCRP

+1-904-244-5617 Andrea.Burton@jax.ufl.edu

Locations

University of Florida

Recruiting

Jacksonville, Florida, United States, 32209

Contacts

Dominick J Angiolillo, MD, PhD

dominick.angiolillo@jax.ufl.edu

Principal Investigator:

Dominick J Angiolillo, MD, PhD

More Information

Sponsor

University of Florida

Last update posted

Mar 9, 2026

Last verified

Mar, 2026

Keywords

Percutaneous coronary intervention
Dual antiplatelet therapy
Bleeding

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 2026-03-09.