Recruiting

SWAP-9

Sponsor:

University of Florida

Code:

NCT06588595

Conditions

Coronary Arterial Disease (CAD)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Prasugrel/Ticagrelor monotherapy or aspirin plus clopidogrel

Aspirin plus clopidogrel

Study Details

Brief summary:

The purpose of this study is to compare the pharmacodynamic effects of ABCD-GENE guided vs. unguided de-escalation strategies among patients on dual antiplatelet therapy (DAPT) following percutaneous coronary intervention (PCI).

Conditions

Coronary Arterial Disease (CAD)

Study ID

NCT06588595

Start date

Nov 1, 2024

Status verified date

Feb, 2026

Completion date

Feb 28, 2027

Anticipated

Primary completion date

Aug 30, 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, composed of low-dose aspirin (81mg qd) with either prasugrel (10 mg qd) or ticagrelor (90 mg bid). 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. PCI within 30 days
3. 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)
4. Hemodynamic instability
5. Hypersensitivity to clopidogrel
6. Known platelet count less than 80x10\^6/mL
7. Known hemoglobin less than 9 g/dL
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

experimental: ABCD-GENE-guided de-escalation

ABCD-GENE ≥10: prasugrel 10 mg qd or ticagrelor 90 mg od monotherapy. ABCD-GENE <10: Aspirin 81 mg qd and clopidogrel 75 mg qd.

active comparator: Unguided de-escalation

Aspirin 81 mg qd and clopidogrel 75 mg qd.

Interventions

Prasugrel/Ticagrelor monotherapy or aspirin plus clopidogrel

After at least 30 days of DAPT \[with aspirin 81-mg qd and a potent P2Y12 inhibitor (prasugrel 10 mg qd or ticagrelor 90-mg BID)\] in chronic coronary syndrome or after at least 90 days of DAPT in acute coronary syndromes; patients with an ABCD-GENE 10 or more will continue prasugrel 10 mg qd/ticagrelor 90 mg BID and drop aspirin; and patients with an ABCD-GENE less than10 will switch from prasugrel/ticagrelor-based DAPT to aspirin 81 mg qd plus clopidogrel 75 mg qd.

Aspirin plus clopidogrel

After at least 30 days of DAPT \[with aspirin 81 mg qd and a potent P2Y12 inhibitor (prasugrel 10 mg qd or ticagrelor 90 mg BID)\] in chronic coronary syndrome or after at least 90 days of DAPT in acute coronary syndromes; patients will switch from prasugrel/ticagrelor-based DAPT to aspirin 81 mg qd plus clopidogrel 75 mg qd, irrespective of ABCD-GENE score.

Primary outcome measure

  • P2Y12 Reaction Units (PRU) [ Time Frame: At 30±5 days (trough levels) ]

Central Contacts and Locations

Central contacts

Locations

University of Florida

Recruiting

Jacksonville, Florida, United States, 32209

Contacts

More Information

Sponsor

University of Florida

Last update posted

Feb 25, 2026

Last verified

Feb, 2026

Keywords

  • ABCD-GENE score
  • Dual antiplatelet therapy (DAPT)
  • Pharmacodynamic (PD) study
  • Percutaneous coronary intervention (PCI)
  • P2Y12 receptor inhibitor

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 2026-02-25.