Ignite Creation Date:
2024-05-06 @ 6:11 PM
Last Modification Date:
2024-10-26 @ 2:43 PM
Study NCT ID:
NCT05577988
Status:
RECRUITING
Last Update Posted:
2024-04-05
First Post:
2022-10-10
Brief Title:
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
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ADEN
Brief Summary:
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
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
Detailed Description:
Multicenter randomized open label trial using the PROBE study design Randomization 1 to 3 months preferably 1 considering the HBR after ACS into 2 parallel arms Stratification according to revascularization status PCI or no PCI genotype loss of function fast metabolization none and center
Control arm stop aspirin for a single antiplatelet therapy with a high-potency antiplatelet ticagrelor or prasugrel
Intervention arm single-antiplatelet with a low-potency antiplatelet aspirin or clopidogrel guided by genetic testing
Control arm stop aspirin for a single antiplatelet therapy with a high-potency antiplatelet ticagrelor or prasugrel
Intervention arm single-antiplatelet with a low-potency antiplatelet aspirin or clopidogrel guided by genetic testing
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 20-0570 PHRC | OTHER | DGOS | None |