ShorT and OPtimal Duration of Dual AntiPlatelet Therapy-3 Study (STOPDAPT-3)

Kyoto University, Graduate School of Medicine

Status and phase: Active, not recruiting; Phase 4

Conditions: Acute Coronary Syndrome

Treatments: Drug: 1-month DAPT; Drug: No aspirin

Study type: Interventional

Funder types: Other

Identifiers

NCT04609111

Y0080

Details and patient eligibility

About

The purpose of this study is to explore the benefit of the prasugrel monotherapy without aspirin as compared with the 1-month dual therapy with aspirin and prasugrel in terms of reducing bleeding events after percutaneous coronary intervention (PCI) using cobalt-chromium everolimus-eluting stents (CoCr-EES, XienceTM) in patients with high bleeding risk or under the acute coronary syndrome patients.

Full description

In the previous trial, 1-month dual antiplatelet therapy (DAPT) followed by clopidogrel monotherapy provided a net clinical benefit for the cardiovascular and bleeding events over 12-month DAPT with aspirin and clopidogrel after cobalt-chromium everolimus-eluting stent (CoCr-EES) implantation. However, even with very short DAPT, the rate of bleeding at 1-year remained very high in other trials that enrolled the patients with high bleeding risk (HBR). Notably, the risk of bleeding in patients with high bleeding risk (HBR) was particularly high within 1-month after percutaneous coronary intervention (PCI) in previous cohort data, when DAPT is implemented even in very short DAPT regimen. More recently, in another trial, prasugrel monotherapy without aspirin immediately after successful stent implantation was associated with no stent thrombosis in selected patients with low risk stable coronary artery disease. Aspirin-free strategy might be particularly beneficial in reducing bleeding in HBR patients. Patients with acute coronary syndrome (ACS) are also reported to be associated with higher risk for bleeding.

Therefore, we have planned a study to compare the cardiovascular and bleeding events at 1-month after PCI using CoCr-EES between no DAPT strategy and 1-month DAPT strategy in patients with HBR or ACS.

Enrollment: 6,002 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who are planned to have percutaneous coronary intervention with exclusive use of everolimus-eluting stent (XienceTM series).
• Patients with high bleeding risk defined by Academic Research Consortium or acute coronary syndrome
• Patients who could take dual antiplatelet therapy with aspirin and P2Y12 inhibitors for 1-month

Exclusion criteria

• Patients who are judged to be unsuitable for participation by the principal investigator and co-investigator
• Patients with a known allergy to the study drugs
• Patients enrolled in the ongoing prospective interventional studies

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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6,002 participants in 2 patient groups

No aspirin

Active Comparator group

Description:

To start prasugrel monotherapy before the index percutaneous coronary intervention (PCI) and to change into clopidogrel monotherapy at 1-month after the PCI.

Treatment:

Drug: No aspirin

1-month DAPT

Active Comparator group

Description:

To start dual antiplatelet therapy comprising of aspirin and prasugrel before the index percutaneous coronary intervention (PCI) and to change into aspirin monotherapy at 1-month after the PCI.

Treatment:

Drug: 1-month DAPT