ShorT and OPtimal Duration of Dual AntiPlatelet Therapy Study After Everolimus-eluting Cobalt-chromium Stent-3
Trial Snapshot
- Phase
- Phase 4
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 6,002
- Locations
- 1
- Primary Endpoint
- Major bleeding
Study Overview
Brief Summary
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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
No aspirin
To start prasugrel monotherapy before the index percutaneous coronary intervention (PCI) and to change into clopidogrel monotherapy at 1-month after the PCI.
Intervention: No aspirin (Drug)
1-month DAPT
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.
Intervention: 1-month DAPT (Drug)
Outcomes
Primary Outcomes
Major bleeding
Time Frame: 1 month
Bleeding defined as BARC criteria 3 or 5
Cardiovascular composite endpoint
Time Frame: 1 month
Composite of cardiovascular death, myocardial infarction, ischemic stroke ,or definite stent thrombosis
Secondary Outcomes
- Death(12 months)
- Cardiovascular death(12 months)
- Myocardial infarction(12 months)
- Stroke(12 months)
- Ischemic stroke(12 months)
- Hemorrhagic stroke(12 months)
- Stent thrombosis(12 months)
- Target lesion failure(12 months)
- Target vessel failure(12 months)
- Any target lesion revascularization(12 months)
- Clinically-driven target lesion revascularization(12 months)
- Non-target lesions revascularization(12 months)
- Coronary artery bypass grafting(12 months)
- Any target vessel revascularization(12 months)
- Any coronary revascularization(12 months)
- Type 2 bleeding in Bleeding Academic Research Consortium (BARC) criteria(12 months)
- Type 3 bleeding in Bleeding Academic Research Consortium (BARC) criteria(12 months)
- Type 4 bleeding in Bleeding Academic Research Consortium (BARC) criteria(12 months)
- Type 5 bleeding in Bleeding Academic Research Consortium (BARC) criteria(12 months)
- Type 2, 3, or 5 bleeding in Bleeding Academic Research Consortium (BARC) criteria(12 months)
- Major bleeding in Thrombolysis in Myocardial Infarction (TIMI) criteria(12 months)
- Minor bleeding in Thrombolysis in Myocardial Infarction (TIMI) criteria(12 months)
- Major or minor bleeding in Thrombolysis in Myocardial Infarction (TIMI) criteria(12 months)
- Severe bleeding in Global Utilization Of Streptokinase And Tpa For Occluded Arteries (GUSTO) criteria(12 months)
- Moderate bleeding in Global Utilization Of Streptokinase And Tpa For Occluded Arteries (GUSTO) criteria(12 months)
- Moderate or severe bleeding in Global Utilization Of Streptokinase And Tpa For Occluded Arteries (GUSTO) criteria(12 months)
- Intracranial bleeding(12 months)
- Gastrointestinal bleeding(12 months)
- Gastrointestinal complaints(12 months)
Investigators
Takeshi Morimoto
Study Statistician
Kyoto University, Graduate School of Medicine