The Switching Antiplatelet-9 (SWAP-9) Study

Part of paid clinical trials in Jacksonville, Florida.

Sponsor
University of Florida
Study ID
NCT06588595
Phase
PHASE4
Status
Recruiting
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Conditions

  • Coronary Arterial Disease (CAD)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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).

Key Dates

Start date
Nov 1, 2024
Status verified
Feb 2026
Primary completion
Aug 30, 2026
Completion
Feb 28, 2027

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of FloridaJacksonvilleFlorida32209
Luis Ortega, MD, PhD
[email protected]
904-244-2060

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By research site
University of Florida· Jacksonville, FL

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