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

Primary Purpose

Acute Coronary Syndrome

Status
Active
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
No aspirin
1-month DAPT
Sponsored by
Kyoto University, Graduate School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Coronary Syndrome focused on measuring stent, percutaneous coronary transluminal angioplasty, bleeding, antiplatelet agents

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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:

  • None

Sites / Locations

  • Kyoto University Graduate School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

No aspirin

1-month DAPT

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Major bleeding
Bleeding defined as BARC criteria 3 or 5
Cardiovascular composite endpoint
Composite of cardiovascular death, myocardial infarction, ischemic stroke ,or definite stent thrombosis

Secondary Outcome Measures

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

Full Information

First Posted
October 23, 2020
Last Updated
June 17, 2023
Sponsor
Kyoto University, Graduate School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT04609111
Brief Title
ShorT and OPtimal Duration of Dual AntiPlatelet Therapy-3 Study
Acronym
STOPDAPT-3
Official Title
ShorT and OPtimal Duration of Dual AntiPlatelet Therapy Study After Everolimus-eluting Cobalt-chromium Stent-3
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 29, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kyoto University, Graduate School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome
Keywords
stent, percutaneous coronary transluminal angioplasty, bleeding, antiplatelet agents

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
6002 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No aspirin
Arm Type
Active Comparator
Arm Description
To start prasugrel monotherapy before the index percutaneous coronary intervention (PCI) and to change into clopidogrel monotherapy at 1-month after the PCI.
Arm Title
1-month DAPT
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
No aspirin
Intervention Description
1-month prasugrel monotherapy followed by clopidogrel monotherapy
Intervention Type
Drug
Intervention Name(s)
1-month DAPT
Intervention Description
1-month dual antiplatelet therapy comprising of aspirin and prasugrel followed by aspirin monotherapy
Primary Outcome Measure Information:
Title
Major bleeding
Description
Bleeding defined as BARC criteria 3 or 5
Time Frame
1 month
Title
Cardiovascular composite endpoint
Description
Composite of cardiovascular death, myocardial infarction, ischemic stroke ,or definite stent thrombosis
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Death
Description
Death from any cause
Time Frame
1 month
Title
Death
Description
Death from any cause
Time Frame
12 months
Title
Cardiovascular death
Description
Death from cardiac or vascular disease
Time Frame
1 month
Title
Cardiovascular death
Description
Death from cardiac or vascular disease
Time Frame
12 months
Title
Myocardial infarction
Description
Defined by arterial revascularization therapies study (ARTS) criteria
Time Frame
1 month
Title
Myocardial infarction
Description
Defined by arterial revascularization therapies study (ARTS) criteria
Time Frame
12 months
Title
Stroke
Description
Including both ischemic and hemorrhagic stroke
Time Frame
1 month
Title
Stroke
Description
Including both ischemic and hemorrhagic stroke
Time Frame
12 months
Title
Ischemic stroke
Description
Ischemic stroke with symptom lasting over 24 hours
Time Frame
1 month
Title
Ischemic stroke
Description
Ischemic stroke with symptom lasting over 24 hours
Time Frame
12 months
Title
Hemorrhagic stroke
Description
Intracerebral hemorrhage or subarachnoidal hemorrhage not associated with trauma
Time Frame
1 month
Title
Hemorrhagic stroke
Description
Intracerebral hemorrhage or subarachnoidal hemorrhage not associated with trauma
Time Frame
12 months
Title
Stent thrombosis
Description
Stent thrombosis defined by Academic Research Consortium definition
Time Frame
1 month
Title
Stent thrombosis
Description
Stent thrombosis defined by Academic Research Consortium definition
Time Frame
12 months
Title
Target lesion failure
Description
The angiographical confirmation of the restenosis of the target lesions
Time Frame
1 month
Title
Target lesion failure
Description
The angiographical confirmation of the restenosis of the target lesions
Time Frame
12 months
Title
Target vessel failure
Description
The angiographical confirmation of the restenosis or new lesion(s) of the target vessels or myocardial infarction involving the territory of target vessels
Time Frame
1 month
Title
Target vessel failure
Description
The angiographical confirmation of the restenosis or new lesion(s) of the target vessels or myocardial infarction involving the territory of target vessels
Time Frame
12 months
Title
Any target lesion revascularization
Description
Revascularization to the target lesions (including 5mm of both ends of the stent(s)) regardless percutaneous coronary intervention or coronary artery bypass grafting
Time Frame
1 month
Title
Any target lesion revascularization
Description
Revascularization to the target lesions (including 5mm of both ends of the stent(s)) regardless percutaneous coronary intervention or coronary artery bypass grafting
Time Frame
12 months
Title
Clinically-driven target lesion revascularization
Description
Target lesion revascularization with the anginal symptoms or the positive test for ischemia
Time Frame
1 month
Title
Clinically-driven target lesion revascularization
Description
Target lesion revascularization with the anginal symptoms or the positive test for ischemia
Time Frame
12 months
Title
Non-target lesions revascularization
Description
Revascularization to non-target lesions regardless percutaneous coronary intervention or coronary artery bypass grafting
Time Frame
1 month
Title
Non-target lesions revascularization
Description
Revascularization to non-target lesions regardless percutaneous coronary intervention or coronary artery bypass grafting
Time Frame
12 months
Title
Coronary artery bypass grafting
Description
Any coronary artery bypass grafting
Time Frame
1 month
Title
Coronary artery bypass grafting
Description
Any coronary artery bypass grafting
Time Frame
12 months
Title
Any target vessel revascularization
Description
Revascularization to the target vessel
Time Frame
1 month
Title
Any target vessel revascularization
Description
Revascularization to the target vessel
Time Frame
12 months
Title
Any coronary revascularization
Description
Revascularization regardless of percutaneous coronary intervention or coronary artery bypass grafting
Time Frame
1 month
Title
Any coronary revascularization
Description
Revascularization regardless of percutaneous coronary intervention or coronary artery bypass grafting
Time Frame
12 months
Title
Type 2 bleeding in Bleeding Academic Research Consortium (BARC) criteria
Description
Type 2 bleeding defined by BARC criteria
Time Frame
1 month
Title
Type 2 bleeding in Bleeding Academic Research Consortium (BARC) criteria
Description
Type 2 bleeding defined by BARC criteria
Time Frame
12 months
Title
Type 3 bleeding in Bleeding Academic Research Consortium (BARC) criteria
Description
Type 3 bleeding defined by BARC criteria
Time Frame
1 month
Title
Type 3 bleeding in Bleeding Academic Research Consortium (BARC) criteria
Description
Type 3 bleeding defined by BARC criteria
Time Frame
12 months
Title
Type 4 bleeding in Bleeding Academic Research Consortium (BARC) criteria
Description
Type 4 bleeding defined by BARC criteria
Time Frame
1 month
Title
Type 4 bleeding in Bleeding Academic Research Consortium (BARC) criteria
Description
Type 4 bleeding defined by BARC criteria
Time Frame
12 months
Title
Type 5 bleeding in Bleeding Academic Research Consortium (BARC) criteria
Description
Type 5 bleeding defined by BARC criteria
Time Frame
1 month
Title
Type 5 bleeding in Bleeding Academic Research Consortium (BARC) criteria
Description
Type 5 bleeding defined by BARC criteria
Time Frame
12 months
Title
Type 2, 3, or 5 bleeding in Bleeding Academic Research Consortium (BARC) criteria
Description
Type 2, 3, or 5 bleeding defined by BARC criteria
Time Frame
1 month
Title
Type 2, 3, or 5 bleeding in Bleeding Academic Research Consortium (BARC) criteria
Description
Type 2, 3, or 5 bleeding defined by BARC criteria
Time Frame
12 months
Title
Major bleeding in Thrombolysis in Myocardial Infarction (TIMI) criteria
Description
Major bleeding defined by TIMI criteria
Time Frame
1 month
Title
Major bleeding in Thrombolysis in Myocardial Infarction (TIMI) criteria
Description
Major bleeding defined by TIMI criteria
Time Frame
12 months
Title
Minor bleeding in Thrombolysis in Myocardial Infarction (TIMI) criteria
Description
Minor bleeding defined by TIMI criteria
Time Frame
1 month
Title
Minor bleeding in Thrombolysis in Myocardial Infarction (TIMI) criteria
Description
Minor bleeding defined by TIMI criteria
Time Frame
12 months
Title
Major or minor bleeding in Thrombolysis in Myocardial Infarction (TIMI) criteria
Description
Major or minor defined by TIMI criteria
Time Frame
1 month
Title
Major or minor bleeding in Thrombolysis in Myocardial Infarction (TIMI) criteria
Description
Major or minor defined by TIMI criteria
Time Frame
12 months
Title
Severe bleeding in Global Utilization Of Streptokinase And Tpa For Occluded Arteries (GUSTO) criteria
Description
Severe bleeding defined by GUSTO criteria
Time Frame
1 month
Title
Severe bleeding in Global Utilization Of Streptokinase And Tpa For Occluded Arteries (GUSTO) criteria
Description
Severe bleeding defined by GUSTO criteria
Time Frame
12 months
Title
Moderate bleeding in Global Utilization Of Streptokinase And Tpa For Occluded Arteries (GUSTO) criteria
Description
Moderate bleeding defined by GUSTO criteria
Time Frame
1 month
Title
Moderate bleeding in Global Utilization Of Streptokinase And Tpa For Occluded Arteries (GUSTO) criteria
Description
Moderate bleeding defined by GUSTO criteria
Time Frame
12 months
Title
Moderate or severe bleeding in Global Utilization Of Streptokinase And Tpa For Occluded Arteries (GUSTO) criteria
Description
Moderate or severe bleeding defined by GUSTO criteria
Time Frame
1 month
Title
Moderate or severe bleeding in Global Utilization Of Streptokinase And Tpa For Occluded Arteries (GUSTO) criteria
Description
Moderate or severe bleeding defined by GUSTO criteria
Time Frame
12 months
Title
Intracranial bleeding
Description
Intracranial bleeding regardless of spontaneous or trauma
Time Frame
1 month
Title
Intracranial bleeding
Description
Intracranial bleeding regardless of spontaneous or trauma
Time Frame
12 months
Title
Gastrointestinal bleeding
Description
Bleeding from gastrointestinal tract regardless of severity
Time Frame
1 month
Title
Gastrointestinal bleeding
Description
Bleeding from gastrointestinal tract regardless of severity
Time Frame
12 months
Title
Gastrointestinal complaints
Description
Requirement of upper gastric fiberscopy to examine the gastrointestinal complaints
Time Frame
1 month
Title
Gastrointestinal complaints
Description
Requirement of upper gastric fiberscopy to examine the gastrointestinal complaints
Time Frame
12 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Takeshi Kimura, MD
Organizational Affiliation
Kyoto University, Graduate School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kyoto University Graduate School of Medicine
City
Kyoto
ZIP/Postal Code
606-8507
Country
Japan

12. IPD Sharing Statement

Plan to Share IPD
No

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ShorT and OPtimal Duration of Dual AntiPlatelet Therapy-3 Study

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