Reduced-dose prasugrel alone after PCI in acute and chronic coronary syndrome
Official title: Prasugrel Monotherapy Reduced Dose in Acute and Chronic Coronary Syndrome Patients After Percutaneous Coronary Intervention
Run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · NCT06916520 · Data updated 2026-11-12
This test tries whether taking a low 5 mg daily dose of prasugrel alone after a successful PCI can prevent clots while lowering bleeding risk in people with acute or chronic coronary syndromes.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Academic / other |
| Drugs / interventions | cyclophosphamide |
| Locations | 1 site (Amsterdam) |
| Status | Recruiting |
| Started | November 13, 2025 |
| Main results expected | April 2026 |
| Study ends | April 2027 |
| Registry record updated | March 4, 2026 |
| Trial ID | NCT06916520 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults who have undergone successful PCI for acute or chronic coronary syndrome, have no contraindication to prasugrel, are not taking oral anticoagulants, and can attend follow-up visits at Amsterdam UMC.
✕Probably not a fit
Patients who require ongoing oral anticoagulation, have a current indication for continued DAPT, have prasugrel allergy or severe liver disease, are pregnant or breastfeeding, or are taking contraindicated CYP2B6 substrate drugs are unlikely to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
PROMOTE is an open-label, single-centre randomized controlled trial comparing reduced-dose prasugrel monotherapy to standard dual antiplatelet therapy in patients undergoing successful PCI for acute or chronic coronary syndromes. After a loading dose, participants randomized to the experimental arm receive prasugrel 5 mg once daily for 6 months (for CCS) or 12 months (for ACS), while the control arm receives conventional aspirin plus a P2Y12 inhibitor per guideline durations. The primary focus is feasibility and safety, with key outcomes including major bleeding and ischemic events such as stent thrombosis and myocardial infarction. Enrollment and follow-up occur at Amsterdam UMC with clinical visits to monitor events, adherence, and tolerability.
Why it matters
Potential benefit: If successful, this approach could reduce bleeding complications and simplify antiplatelet therapy after PCI.
How similar studies have gone: Other trials of P2Y12 inhibitor monotherapy after short DAPT (for example with ticagrelor or clopidogrel) have reduced bleeding while maintaining ischemic protection, but reduced-dose prasugrel monotherapy is less well studied.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Acute Coronary Syndrome * Chronic Coronary Syndrome * Successful PCI Exclusion Criteria: * 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 use of CYP2B6 substrates with a narrow therapeutic window (e.g. cyclophosphamide, efavirenz)
Where it's running
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Amsterdam UMC
Amsterdam, Netherlands Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.