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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Acute Coronary Syndrome
• Intervention / Treatment: Drug: No aspirin; Drug: 1-month DAPT

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 Type: Interventional
• Enrollment (Actual): 6002
• Phase: Phase 4

Contacts and Locations

Study Locations

• Japan
  • Kyoto, Japan, 606-8507
    • Kyoto University Graduate School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Drug: No aspirin; 1-month prasugrel monotherapy followed by clopidogrel monotherapy
Active Comparator: 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.	Drug: 1-month DAPT; 1-month dual antiplatelet therapy comprising of aspirin and prasugrel followed by aspirin monotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major bleeding	Bleeding defined as BARC criteria 3 or 5	1 month
Cardiovascular composite endpoint	Composite of cardiovascular death, myocardial infarction, ischemic stroke ,or definite stent thrombosis	1 month

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Kyoto University, Graduate School of Medicine
• Investigators: Principal Investigator: Takeshi Kimura, MD, Kyoto University, Graduate School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2021
• Primary Completion (Actual): December 31, 2023
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: October 23, 2020
• First Submitted That Met QC Criteria: October 23, 2020
• First Posted (Actual): October 30, 2020

Study Record Updates

• Last Update Posted (Actual): June 14, 2024
• Last Update Submitted That Met QC Criteria: June 12, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: bleeding; stent; percutaneous coronary transluminal angioplasty; antiplatelet agents
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Acute Coronary Syndrome; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Aspirin
• Other Study ID Numbers: Y0080

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No