Clinical trial NCT04609111: ShorT and OPtimal Duration of Dual AntiPlatelet Therapy-3 Study
Official title: ShorT and OPtimal Duration of Dual AntiPlatelet Therapy Study After Everolimus-eluting Cobalt-chromium Stent-3
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Acute Coronary Syndrome
Keywords: stent
percutaneous coronary transluminal angioplasty
bleeding
antiplatelet agents
Lead sponsor: Kyoto University, Graduate School of Medicine
Sponsor class: OTHER
First posted: 2020-10-30
Enrollment: 6002
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Major bleeding
timeFrame: 1 month
measure: Cardiovascular composite endpoint
timeFrame: 1 month
Secondary outcomes:
measure: Death
timeFrame: 1 month
measure: Death
timeFrame: 12 months
measure: Cardiovascular death
timeFrame: 1 month
measure: Cardiovascular death
timeFrame: 12 months
measure: Myocardial infarction
timeFrame: 1 month
measure: Myocardial infarction
timeFrame: 12 months
measure: Stroke
timeFrame: 1 month
measure: Stroke
timeFrame: 12 months
measure: Ischemic stroke
timeFrame: 1 month
measure: Ischemic stroke
timeFrame: 12 months
measure: Hemorrhagic stroke
timeFrame: 1 month
measure: Hemorrhagic stroke
timeFrame: 12 months
measure: Stent thrombosis
timeFrame: 1 month
measure: Stent thrombosis
timeFrame: 12 months
measure: Target lesion failure
timeFrame: 1 month
measure: Target lesion failure
timeFrame: 12 months
measure: Target vessel failure
timeFrame: 1 month
measure: Target vessel failure
timeFrame: 12 months
measure: Any target lesion revascularization
timeFrame: 1 month
measure: Any target lesion revascularization
timeFrame: 12 months
measure: Clinically-driven target lesion revascularization
timeFrame: 1 month
measure: Clinically-driven target lesion revascularization
timeFrame: 12 months
measure: Non-target lesions revascularization
timeFrame: 1 month
measure: Non-target lesions revascularization
timeFrame: 12 months
measure: Coronary artery bypass grafting
timeFrame: 1 month
measure: Coronary artery bypass grafting
timeFrame: 12 months
measure: Any target vessel revascularization
timeFrame: 1 month
measure: Any target vessel revascularization
timeFrame: 12 months
measure: Any coronary revascularization
timeFrame: 1 month
measure: Any coronary revascularization
timeFrame: 12 months
measure: Type 2 bleeding in Bleeding Academic Research Consortium (BARC) criteria
timeFrame: 1 month
measure: Type 2 bleeding in Bleeding Academic Research Consortium (BARC) criteria
timeFrame: 12 months
measure: Type 3 bleeding in Bleeding Academic Research Consortium (BARC) criteria
timeFrame: 1 month
measure: Type 3 bleeding in Bleeding Academic Research Consortium (BARC) criteria
timeFrame: 12 months
measure: Type 4 bleeding in Bleeding Academic Research Consortium (BARC) criteria
timeFrame: 1 month
measure: Type 4 bleeding in Bleeding Academic Research Consortium (BARC) criteria
timeFrame: 12 months
measure: Type 5 bleeding in Bleeding Academic Research Consortium (BARC) criteria
timeFrame: 1 month
measure: Type 5 bleeding in Bleeding Academic Research Consortium (BARC) criteria
timeFrame: 12 months
measure: Type 2, 3, or 5 bleeding in Bleeding Academic Research Consortium (BARC) criteria
timeFrame: 1 month
measure: Type 2, 3, or 5 bleeding in Bleeding Academic Research Consortium (BARC) criteria
timeFrame: 12 months
measure: Major bleeding in Thrombolysis in Myocardial Infarction (TIMI) criteria
timeFrame: 1 month
measure: Major bleeding in Thrombolysis in Myocardial Infarction (TIMI) criteria
timeFrame: 12 months
measure: Minor bleeding in Thrombolysis in Myocardial Infarction (TIMI) criteria
timeFrame: 1 month
measure: Minor bleeding in Thrombolysis in Myocardial Infarction (TIMI) criteria
timeFrame: 12 months
measure: Major or minor bleeding in Thrombolysis in Myocardial Infarction (TIMI) criteria
timeFrame: 1 month
measure: Major or minor bleeding in Thrombolysis in Myocardial Infarction (TIMI) criteria
timeFrame: 12 months
measure: Severe bleeding in Global Utilization Of Streptokinase And Tpa For Occluded Arteries (GUSTO) criteria
timeFrame: 1 month
measure: Severe bleeding in Global Utilization Of Streptokinase And Tpa For Occluded Arteries (GUSTO) criteria
timeFrame: 12 months
measure: Moderate bleeding in Global Utilization Of Streptokinase And Tpa For Occluded Arteries (GUSTO) criteria
timeFrame: 1 month
measure: Moderate bleeding in Global Utilization Of Streptokinase And Tpa For Occluded Arteries (GUSTO) criteria
timeFrame: 12 months
measure: Moderate or severe bleeding in Global Utilization Of Streptokinase And Tpa For Occluded Arteries (GUSTO) criteria
timeFrame: 1 month
measure: Moderate or severe bleeding in Global Utilization Of Streptokinase And Tpa For Occluded Arteries (GUSTO) criteria
timeFrame: 12 months
measure: Intracranial bleeding
timeFrame: 1 month
measure: Intracranial bleeding
timeFrame: 12 months
measure: Gastrointestinal bleeding
timeFrame: 1 month
measure: Gastrointestinal bleeding
timeFrame: 12 months
measure: Gastrointestinal complaints
timeFrame: 1 month
measure: Gastrointestinal complaints
timeFrame: 12 months
Other outcomes:
Locations:
city: Kyoto
country: Japan
facility: Kyoto University Graduate School of Medicine
Study officials:
affiliation: Kyoto University, Graduate School of Medicine
name: Takeshi Kimura, MD
role: PRINCIPAL_INVESTIGATOR
References: