RECRUITING

The Switching Antiplatelet-9 (SWAP-9) Study

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

Comparison of ABCD-GENE Score-Guided Versus Unguided DAPT De-Escalation: A Prospective Randomized Pharmacodynamic Study in Patients Undergoing PCI The Switching Antiplatelet-9 (SWAP-9) Study

Quick Facts

Study Start:2024-11-01

Study Completion:2027-02-28

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06588595

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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 \[women of childbearing age must use reliable birth control (i.e., oral contraceptives) while participating in the study\].

Inclusion Criteria

Exclusion 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.

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 \[women of childbearing age must use reliable birth control (i.e., oral contraceptives) while participating in the study\].

Contacts and Locations

Study Contact

Luis Ortega, MD, PhD

CONTACT

904-244 2060

Luis.Ortega@jax.ufl.edu

Andrea Burton, MPH, CCRP

CONTACT

904-244-5617

Andrea.Burton@jax.ufl.edu

Study Locations (Sites)

University of Florida

Jacksonville, Florida, 32209

United States

Collaborators and Investigators

Sponsor: University of Florida

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-01

Study Completion Date2027-02-28

Study Record Updates

Study Start Date2024-11-01

Study Completion Date2027-02-28

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

Coronary Arterial Disease (CAD)