Recruiting

Dual Antiplatelet Therapy

Sponsor:

University of Florida

Code:

NCT06821191

Conditions

Coronary Artery Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

clopidogrel 75 mg

Prasugrel 5 mg

Study Details

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

Study ID

NCT06821191

Start date

Mar 10, 2025

Status verified date

May, 2026

Completion date

Jan 7, 2027

Anticipated

Primary completion date

Nov 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. 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.
2. Age ≥18 years.
3. Provide written informed consent.

Exclusion Criteria:

1. Prior history of stent thrombosis
2. Prior cerebrovascular event
3. PCI within 30 days
4. Predicted poor metabolizer of clopidogrel based on CYP2C19 genotyping (e.g., \*2/\*2 or \*3/\*3),
5. 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)
6. Hemodynamic instability
7. Hypersensitivity to Aspirin, Clopidogrel, or Prasugrel
8. Known hematologic malignancies or thrombocytopenia (platelet count <80x106/mL)
9. Known hemoglobinopathies or anemia (hemoglobin <9 g/dL)
10. 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

78 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: DAPT de-escalation by switch

experimental: DAPT de-escalation by dose-reduction

Interventions

clopidogrel 75 mg

Clopidogrel 75 mg od for 30 ± 5 days

Prasugrel 5 mg

Prasugrel 5 mg od for 30 ± 5 days

Primary outcome measure

  • Platelet reactivity measured by VerifyNow [ Time Frame: 30±5 days ]

Central Contacts and Locations

Central contacts

Locations

University of Florida

Recruiting

Jacksonville, Florida, United States, 32209

Contacts

Principal Investigator:

Luis Ortega, MD, PhD

More Information

Sponsor

University of Florida

Last update posted

May 12, 2026

Last verified

May, 2026

Keywords

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

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 2026-05-12.