The Switching Antiplatelet-9 (SWAP-9) Study

ConditionCoronary Arterial Disease (CAD)

Trial statusRecruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age18+

SponsorUniversity of Florida

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Age ≥18 years

Provide written informed consent.

Disqualifiers

Prior history of stent thrombosis

PCI within 30 days

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)

Hemodynamic instability

Trial design

Design model

Parallel

Treatments tested in this trial

Prasugrel/Ticagrelor monotherapy or aspirin plus clopidogrel
Drug
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
Drug
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.

Treatment groups

90 Participants

are divided into 2 treatment groups

Group A: ABCD-GENE-guided de-escalationExperimental treatment 1 intervention

Group B: Unguided de-escalationActive comparator 1 intervention

Trial outcomes

Primary outcomes

P2Y12 Reaction Units (PRU)

Comparison of PRU determined by VerifyNow between ABCD-GENE-guided de-escalation vs. unguided de-escalation.

Time frame

At 30±5 days (trough levels)

Secondary outcomes

P2Y12 Reaction Units (PRU)

Comparison of the PRU trough levels determined by VerifyNow between clopidogrel-treated patients in the ABCD-GENE-guided de-escalation group (patients with ABCD-GENE score less than 10) and clopidogrel-treated patients in the unguided de-escalation group.

Time frame

At 30±5 days (trough levels)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Florida

Lead sponsor

Source ClinicalTrials.gov

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