Status:
NOT_YET_RECRUITING
Prasugrel Monotherapy Reduced Dose in Acute and Chronic Coronary Syndrome Patients After Percutaneous Coronary Intervention (PROMOTE)
Lead Sponsor:
J.P.S Henriques
Conditions:
Coronary Arterial Disease (CAD)
Percutaneous Coronary Intervention (PCI)
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Rationale: Dual antiplatelet therapy, consisting of aspirin and a P2Y12-inhibitor, reduces the risk of stent-related and non-stent-related ischemic events after percutaneous coronary intervention (PCI...
Eligibility Criteria
Inclusion
- Acute Coronary Syndrome
- Chronic Coronary Syndrome
- Successful PCI
Exclusion
- Known allergy or contraindication for prasugrel, including Active pathological bleeding Severe liver disease (defined as Child Pugh class C)
- Current indication for oral anticoagulant therapy (OAC)
- Indication for ongoing DAPT (e.g. PCI ≤ 6 months for CCS or ACS ≤ 12 months)
- Pregnancy or breast-feeding women
- Participation in another trial with an investigational drug or device
- Recent or ongoing strong CYP3A4 inhibitor or inducer therapy (e.g. clarithromycin, ketoconazole, carbamazepine or rifampicin)
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2027
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT06916520
Start Date
September 1 2025
End Date
April 1 2027
Last Update
April 8 2025
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