ShorT and OPtimal Duration of Dual AntiPlatelet Therapy-3 Study

Acute Coronary Syndrome Clinical Trial

— STOPDAPT-3  

Official title:

ShorT and OPtimal Duration of Dual AntiPlatelet Therapy Study After Everolimus-eluting Cobalt-chromium Stent-3

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04609111
• Other study ID #: Y0080
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: January 29, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: June 2024
• Source: Kyoto University, Graduate School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 6002
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome

Intervention

Drug:
• No aspirin
1-month prasugrel monotherapy followed by clopidogrel monotherapy
• 1-month DAPT
1-month dual antiplatelet therapy comprising of aspirin and prasugrel followed by aspirin monotherapy

Locations

Country	Name	City	State
Japan	Kyoto University Graduate School of Medicine	Kyoto

Sponsors (1)

Lead Sponsor	Collaborator
Kyoto University, Graduate School of Medicine

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major bleeding	Bleeding defined as BARC criteria 3 or 5	1 month
Primary	Cardiovascular composite endpoint	Composite of cardiovascular death, myocardial infarction, ischemic stroke ,or definite stent thrombosis	1 month
Secondary	Death	Death from any cause	1 month
Secondary	Death	Death from any cause	12 months
Secondary	Cardiovascular death	Death from cardiac or vascular disease	1 month
Secondary	Cardiovascular death	Death from cardiac or vascular disease	12 months
Secondary	Myocardial infarction	Defined by arterial revascularization therapies study (ARTS) criteria	1 month
Secondary	Myocardial infarction	Defined by arterial revascularization therapies study (ARTS) criteria	12 months
Secondary	Stroke	Including both ischemic and hemorrhagic stroke	1 month
Secondary	Stroke	Including both ischemic and hemorrhagic stroke	12 months
Secondary	Ischemic stroke	Ischemic stroke with symptom lasting over 24 hours	1 month
Secondary	Ischemic stroke	Ischemic stroke with symptom lasting over 24 hours	12 months
Secondary	Hemorrhagic stroke	Intracerebral hemorrhage or subarachnoidal hemorrhage not associated with trauma	1 month
Secondary	Hemorrhagic stroke	Intracerebral hemorrhage or subarachnoidal hemorrhage not associated with trauma	12 months
Secondary	Stent thrombosis	Stent thrombosis defined by Academic Research Consortium definition	1 month
Secondary	Stent thrombosis	Stent thrombosis defined by Academic Research Consortium definition	12 months
Secondary	Target lesion failure	The angiographical confirmation of the restenosis of the target lesions	1 month
Secondary	Target lesion failure	The angiographical confirmation of the restenosis of the target lesions	12 months
Secondary	Target vessel failure	The angiographical confirmation of the restenosis or new lesion(s) of the target vessels or myocardial infarction involving the territory of target vessels	1 month
Secondary	Target vessel failure	The angiographical confirmation of the restenosis or new lesion(s) of the target vessels or myocardial infarction involving the territory of target vessels	12 months
Secondary	Any target lesion revascularization	Revascularization to the target lesions (including 5mm of both ends of the stent(s)) regardless percutaneous coronary intervention or coronary artery bypass grafting	1 month
Secondary	Any target lesion revascularization	Revascularization to the target lesions (including 5mm of both ends of the stent(s)) regardless percutaneous coronary intervention or coronary artery bypass grafting	12 months
Secondary	Clinically-driven target lesion revascularization	Target lesion revascularization with the anginal symptoms or the positive test for ischemia	1 month
Secondary	Clinically-driven target lesion revascularization	Target lesion revascularization with the anginal symptoms or the positive test for ischemia	12 months
Secondary	Non-target lesions revascularization	Revascularization to non-target lesions regardless percutaneous coronary intervention or coronary artery bypass grafting	1 month
Secondary	Non-target lesions revascularization	Revascularization to non-target lesions regardless percutaneous coronary intervention or coronary artery bypass grafting	12 months
Secondary	Coronary artery bypass grafting	Any coronary artery bypass grafting	1 month
Secondary	Coronary artery bypass grafting	Any coronary artery bypass grafting	12 months
Secondary	Any target vessel revascularization	Revascularization to the target vessel	1 month
Secondary	Any target vessel revascularization	Revascularization to the target vessel	12 months
Secondary	Any coronary revascularization	Revascularization regardless of percutaneous coronary intervention or coronary artery bypass grafting	1 month
Secondary	Any coronary revascularization	Revascularization regardless of percutaneous coronary intervention or coronary artery bypass grafting	12 months
Secondary	Type 2 bleeding in Bleeding Academic Research Consortium (BARC) criteria	Type 2 bleeding defined by BARC criteria	1 month
Secondary	Type 2 bleeding in Bleeding Academic Research Consortium (BARC) criteria	Type 2 bleeding defined by BARC criteria	12 months
Secondary	Type 3 bleeding in Bleeding Academic Research Consortium (BARC) criteria	Type 3 bleeding defined by BARC criteria	1 month
Secondary	Type 3 bleeding in Bleeding Academic Research Consortium (BARC) criteria	Type 3 bleeding defined by BARC criteria	12 months
Secondary	Type 4 bleeding in Bleeding Academic Research Consortium (BARC) criteria	Type 4 bleeding defined by BARC criteria	1 month
Secondary	Type 4 bleeding in Bleeding Academic Research Consortium (BARC) criteria	Type 4 bleeding defined by BARC criteria	12 months
Secondary	Type 5 bleeding in Bleeding Academic Research Consortium (BARC) criteria	Type 5 bleeding defined by BARC criteria	1 month
Secondary	Type 5 bleeding in Bleeding Academic Research Consortium (BARC) criteria	Type 5 bleeding defined by BARC criteria	12 months
Secondary	Type 2, 3, or 5 bleeding in Bleeding Academic Research Consortium (BARC) criteria	Type 2, 3, or 5 bleeding defined by BARC criteria	1 month
Secondary	Type 2, 3, or 5 bleeding in Bleeding Academic Research Consortium (BARC) criteria	Type 2, 3, or 5 bleeding defined by BARC criteria	12 months
Secondary	Major bleeding in Thrombolysis in Myocardial Infarction (TIMI) criteria	Major bleeding defined by TIMI criteria	1 month
Secondary	Major bleeding in Thrombolysis in Myocardial Infarction (TIMI) criteria	Major bleeding defined by TIMI criteria	12 months
Secondary	Minor bleeding in Thrombolysis in Myocardial Infarction (TIMI) criteria	Minor bleeding defined by TIMI criteria	1 month
Secondary	Minor bleeding in Thrombolysis in Myocardial Infarction (TIMI) criteria	Minor bleeding defined by TIMI criteria	12 months
Secondary	Major or minor bleeding in Thrombolysis in Myocardial Infarction (TIMI) criteria	Major or minor defined by TIMI criteria	1 month
Secondary	Major or minor bleeding in Thrombolysis in Myocardial Infarction (TIMI) criteria	Major or minor defined by TIMI criteria	12 months
Secondary	Severe bleeding in Global Utilization Of Streptokinase And Tpa For Occluded Arteries (GUSTO) criteria	Severe bleeding defined by GUSTO criteria	1 month
Secondary	Severe bleeding in Global Utilization Of Streptokinase And Tpa For Occluded Arteries (GUSTO) criteria	Severe bleeding defined by GUSTO criteria	12 months
Secondary	Moderate bleeding in Global Utilization Of Streptokinase And Tpa For Occluded Arteries (GUSTO) criteria	Moderate bleeding defined by GUSTO criteria	1 month
Secondary	Moderate bleeding in Global Utilization Of Streptokinase And Tpa For Occluded Arteries (GUSTO) criteria	Moderate bleeding defined by GUSTO criteria	12 months
Secondary	Moderate or severe bleeding in Global Utilization Of Streptokinase And Tpa For Occluded Arteries (GUSTO) criteria	Moderate or severe bleeding defined by GUSTO criteria	1 month
Secondary	Moderate or severe bleeding in Global Utilization Of Streptokinase And Tpa For Occluded Arteries (GUSTO) criteria	Moderate or severe bleeding defined by GUSTO criteria	12 months
Secondary	Intracranial bleeding	Intracranial bleeding regardless of spontaneous or trauma	1 month
Secondary	Intracranial bleeding	Intracranial bleeding regardless of spontaneous or trauma	12 months
Secondary	Gastrointestinal bleeding	Bleeding from gastrointestinal tract regardless of severity	1 month
Secondary	Gastrointestinal bleeding	Bleeding from gastrointestinal tract regardless of severity	12 months
Secondary	Gastrointestinal complaints	Requirement of upper gastric fiberscopy to examine the gastrointestinal complaints	1 month
Secondary	Gastrointestinal complaints	Requirement of upper gastric fiberscopy to examine the gastrointestinal complaints	12 months