Tailoring Bleeding Reduction Approaches in Patients Undergoing PCI

Part of paid clinical trials in Jacksonville, Florida.

Sponsor
University of Florida
Study ID
NCT05681702
Phase
PHASE4
Status
Recruiting
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Conditions

  • Coronary Artery Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • aspirin plus clopidogrel — DRUG
    After at least 30 days of DAPT \[with aspirin 81-mg od and a potent P2Y12 inhibitor (prasugrel 10 mg od or ticagrelor 90-mg BID)\] in chronic coronary syndrome or after at least 90 days of DAPT in acute coronary syndromes; patients will continue aspirin and switch to clopidogrel 75-mg.
  • prasugrel or ticagrelor — DRUG
    After at least 30 days of DAPT \[with aspirin 81-mg od and a potent P2Y12 inhibitor (prasugrel 10 mg od or ticagrelor 90-mg BID)\] in chronic coronary syndrome or after at least 90 days of DAPT in acute coronary syndromes; patients will drop aspirin and continue prasugrel or ticagrelor.

Study Details

Two strategies have both proven to be effective in reducing bleeding complications while preserving efficacy compared with maintaining long-term DAPT with aspirin and a potent P2Y12 inhibitor: a) DAPT de-escalation (i.e., switching from prasugrel or ticagrelor to clopidogrel while maintaining aspirin) and b) potent P2Y12 inhibitor monotherapy (i.e., maintaining prasugrel or ticagrelor and dropping aspirin). These strategies have been tested in a number of trials and have led to changes in practice guidelines to consider either one of these strategies as bleeding reduction approaches among ACS patients undergoing PCI. However, comparative assessments between DAPT de-escalation and potent P2Y12 inhibitor monotherapy are lacking.

Key Dates

Start date
Feb 15, 2023
Status verified
Mar 2026
Primary completion
Dec 31, 2026
Completion
Mar 31, 2027

Study Design

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

Arms

  • Active Comparator: DAPT de-escalation
    Aspirin 81-mg od and clopidogrel 75-mg qd.
  • Experimental: Potent P2Y12 monotherapy
    Potent P2Y12 inhibitor with prasugrel 10 mg od or ticagrelor 90 mg BID.

Primary Outcome Measure

Thrombus formation defined as AUC measured by T-TAS [ Time Frame: 30 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of FloridaJacksonvilleFlorida32209
Dominick J Angiolillo, MD, PhD
[email protected]
Dominick J Angiolillo, MD, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Florida· Jacksonville, FL

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