Assessment of an Early De-Escalation to a Low-potency Single Antiplatelet Therapy Guided by Genetics Versus a Systematic High-Potency Single Antiplatelet Therapy to Neutralize Bleeding Complications in Patients With High Bleeding Risk Beyond One Month After an Acute Coronary Syndrome

Sponsor
Assistance Publique - Hôpitaux de Paris
Study ID
NCT05577988
Phase
PHASE3
Status
Recruiting
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Conditions

  • MYOCARDIAL INFARCTION

Eligibility Criteria

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

Interventions

  • single-antiplatelet with a low-potency antiplatelet (aspirin or clopidogrel) guided by genetic testing. — OTHER
    * Individuals without genetic loss of function to metabolize clopidogrel (\*1/\*1, \*2/\*17, \*3/\*17): stop DAPT and switch to a single antiplatelet therapy by clopidogrel. * Individuals with genetic loss of function to metabolize clopidogrel (\*2/\*3, 1/\*3, \*2/\*2, \*1/\*2,\*3/\*3): stop potent P2Y12 inhibitor and treat with a single antiplatelet therapy by aspirin. * Individuals with fast metabolization of clopidogrel (\*1/\*17 or \*17/\*17): stop potent P2Y12 inhibitor and treat with a single antiplatelet therapy by aspirin.

Study Details

Patients who suffered from acute coronary syndrome (ACS) are usually treated with a long-term dual antiplatelet therapy (DAPT) to reduce stent thrombosis and recurrent ischemic event. Nonetheless, recent important data have demonstrated the efficacy of a short term DAPT and an early single antiplatelet therapy in high bleeding and ischemic risk patients. The bleeding risk is associated with a significant mortality. This risk is especially high in patients treated with potent P2Y12 inhibitors like ticagrelor or prasugrel after an ACS. As a result of the abounding data regarding the safety of an early single antiplatelet therapy with high potency antiplatelet therapy (ticagrelor or prasugrel), it is likely that such strategy will soon be implemented in the guidelines. The benefits of these high-potency P2Y12 inhibitors over clopidogrel mostly occur in patients with genetic polymorphisms of CYP2Y12 associated with a loss of function in clopidogrel metabolism. Furthermore, the anti-ischemic benefit of potent P2Y12 inhibitors over clopidogrel occurs early, while excess bleeding events often arise during chronic treatment. Our hypothesis is that a systematic and rapid genetic screening of CYP2C90 \*2 or \*17 polymorphism to guide an early single therapy with low potency antiplatelet (aspirin or clopidogrel) could lead to less bleeding events with a consistent efficacy towards cardiac events compared with high potency antiplatelet therapies (prasugrel or ticagrelor) in high bleeding risk patients treated for ACS.

Key Dates

First listed
Oct 13, 2022
Start date
Jun 18, 2024
Status verified
Jan 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
2,468 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • No Intervention: Control arm
    Standard of Care : Systematic de-escalation to a high potency antiplatelet single therapy
  • Other: Intervention arm
    single-antiplatelet with a low-potency antiplatelet (aspirin or clopidogrel) guided by genetic testing.

Primary Outcome Measure

Rate of combinated major and minor bleeding events (BARC 2 to 5 BARC) [ Time Frame: From randomization (1-3months after inclusion) to 1year after inclusion ]

Central Contacts

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