Comparison of Dual Antiplatelet Therapy De-escalation by Dose Reduction Versus Switching in Patients Undergoing PCI: The Switching Antiplatelet-8 (SWAP-8) Study

Part of paid clinical trials in Jacksonville, Florida.

Sponsor
University of Florida
Study ID
NCT06821191
Phase
PHASE4
Status
Recruiting
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Conditions

  • Coronary Artery Disease

Eligibility Criteria

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

Interventions

  • clopidogrel 75 mg — DRUG
    Clopidogrel 75 mg od for 30 ± 5 days
  • Prasugrel 5 mg — DRUG
    Prasugrel 5 mg od for 30 ± 5 days

Study Details

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.

Key Dates

Start date
Mar 10, 2025
Status verified
May 2026
Primary completion
Nov 1, 2026
Completion
Jan 7, 2027

Study Design

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

Arms

  • Active Comparator: DAPT de-escalation by switch
  • Experimental: DAPT de-escalation by dose-reduction

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of FloridaJacksonvilleFlorida32209
Luis Ortega, MD, PhD
[email protected]
904-244-2060
Andrea Burton, MPH, CCRP
[email protected]
904-244-5617
Luis Ortega, MD, PhD (PRINCIPAL_INVESTIGATOR)

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