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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04609111
Recruitment Status : Active, not recruiting
First Posted : October 30, 2020
Last Update Posted : June 22, 2023
Sponsor:
Information provided by (Responsible Party):
Takeshi Morimoto, Kyoto University, Graduate School of Medicine

Tracking Information
First Submitted Date  ICMJE October 23, 2020
First Posted Date  ICMJE October 30, 2020
Last Update Posted Date June 22, 2023
Actual Study Start Date  ICMJE January 29, 2021
Estimated Primary Completion Date December 31, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 23, 2020)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 17, 2023)
  • Death [ Time Frame: 1 month ]
    Death from any cause
  • Death [ Time Frame: 12 months ]
    Death from any cause
  • Cardiovascular death [ Time Frame: 1 month ]
    Death from cardiac or vascular disease
  • Cardiovascular death [ Time Frame: 12 months ]
    Death from cardiac or vascular disease
  • Myocardial infarction [ Time Frame: 1 month ]
    Defined by arterial revascularization therapies study (ARTS) criteria
  • Myocardial infarction [ Time Frame: 12 months ]
    Defined by arterial revascularization therapies study (ARTS) criteria
  • Stroke [ Time Frame: 1 month ]
    Including both ischemic and hemorrhagic stroke
  • Stroke [ Time Frame: 12 months ]
    Including both ischemic and hemorrhagic stroke
  • Ischemic stroke [ Time Frame: 1 month ]
    Ischemic stroke with symptom lasting over 24 hours
  • Ischemic stroke [ Time Frame: 12 months ]
    Ischemic stroke with symptom lasting over 24 hours
  • Hemorrhagic stroke [ Time Frame: 1 month ]
    Intracerebral hemorrhage or subarachnoidal hemorrhage not associated with trauma
  • Hemorrhagic stroke [ Time Frame: 12 months ]
    Intracerebral hemorrhage or subarachnoidal hemorrhage not associated with trauma
  • Stent thrombosis [ Time Frame: 1 month ]
    Stent thrombosis defined by Academic Research Consortium definition
  • Stent thrombosis [ Time Frame: 12 months ]
    Stent thrombosis defined by Academic Research Consortium definition
  • Target lesion failure [ Time Frame: 1 month ]
    The angiographical confirmation of the restenosis of the target lesions
  • Target lesion failure [ Time Frame: 12 months ]
    The angiographical confirmation of the restenosis of the target lesions
  • Target vessel failure [ Time Frame: 1 month ]
    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 [ Time Frame: 12 months ]
    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 [ Time Frame: 1 month ]
    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 [ Time Frame: 12 months ]
    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 [ Time Frame: 1 month ]
    Target lesion revascularization with the anginal symptoms or the positive test for ischemia
  • Clinically-driven target lesion revascularization [ Time Frame: 12 months ]
    Target lesion revascularization with the anginal symptoms or the positive test for ischemia
  • Non-target lesions revascularization [ Time Frame: 1 month ]
    Revascularization to non-target lesions regardless percutaneous coronary intervention or coronary artery bypass grafting
  • Non-target lesions revascularization [ Time Frame: 12 months ]
    Revascularization to non-target lesions regardless percutaneous coronary intervention or coronary artery bypass grafting
  • Coronary artery bypass grafting [ Time Frame: 1 month ]
    Any coronary artery bypass grafting
  • Coronary artery bypass grafting [ Time Frame: 12 months ]
    Any coronary artery bypass grafting
  • Any target vessel revascularization [ Time Frame: 1 month ]
    Revascularization to the target vessel
  • Any target vessel revascularization [ Time Frame: 12 months ]
    Revascularization to the target vessel
  • Any coronary revascularization [ Time Frame: 1 month ]
    Revascularization regardless of percutaneous coronary intervention or coronary artery bypass grafting
  • Any coronary revascularization [ Time Frame: 12 months ]
    Revascularization regardless of percutaneous coronary intervention or coronary artery bypass grafting
  • Type 2 bleeding in Bleeding Academic Research Consortium (BARC) criteria [ Time Frame: 1 month ]
    Type 2 bleeding defined by BARC criteria
  • Type 2 bleeding in Bleeding Academic Research Consortium (BARC) criteria [ Time Frame: 12 months ]
    Type 2 bleeding defined by BARC criteria
  • Type 3 bleeding in Bleeding Academic Research Consortium (BARC) criteria [ Time Frame: 1 month ]
    Type 3 bleeding defined by BARC criteria
  • Type 3 bleeding in Bleeding Academic Research Consortium (BARC) criteria [ Time Frame: 12 months ]
    Type 3 bleeding defined by BARC criteria
  • Type 4 bleeding in Bleeding Academic Research Consortium (BARC) criteria [ Time Frame: 1 month ]
    Type 4 bleeding defined by BARC criteria
  • Type 4 bleeding in Bleeding Academic Research Consortium (BARC) criteria [ Time Frame: 12 months ]
    Type 4 bleeding defined by BARC criteria
  • Type 5 bleeding in Bleeding Academic Research Consortium (BARC) criteria [ Time Frame: 1 month ]
    Type 5 bleeding defined by BARC criteria
  • Type 5 bleeding in Bleeding Academic Research Consortium (BARC) criteria [ Time Frame: 12 months ]
    Type 5 bleeding defined by BARC criteria
  • Type 2, 3, or 5 bleeding in Bleeding Academic Research Consortium (BARC) criteria [ Time Frame: 1 month ]
    Type 2, 3, or 5 bleeding defined by BARC criteria
  • Type 2, 3, or 5 bleeding in Bleeding Academic Research Consortium (BARC) criteria [ Time Frame: 12 months ]
    Type 2, 3, or 5 bleeding defined by BARC criteria
  • Major bleeding in Thrombolysis in Myocardial Infarction (TIMI) criteria [ Time Frame: 1 month ]
    Major bleeding defined by TIMI criteria
  • Major bleeding in Thrombolysis in Myocardial Infarction (TIMI) criteria [ Time Frame: 12 months ]
    Major bleeding defined by TIMI criteria
  • Minor bleeding in Thrombolysis in Myocardial Infarction (TIMI) criteria [ Time Frame: 1 month ]
    Minor bleeding defined by TIMI criteria
  • Minor bleeding in Thrombolysis in Myocardial Infarction (TIMI) criteria [ Time Frame: 12 months ]
    Minor bleeding defined by TIMI criteria
  • Major or minor bleeding in Thrombolysis in Myocardial Infarction (TIMI) criteria [ Time Frame: 1 month ]
    Major or minor defined by TIMI criteria
  • Major or minor bleeding in Thrombolysis in Myocardial Infarction (TIMI) criteria [ Time Frame: 12 months ]
    Major or minor defined by TIMI criteria
  • Severe bleeding in Global Utilization Of Streptokinase And Tpa For Occluded Arteries (GUSTO) criteria [ Time Frame: 1 month ]
    Severe bleeding defined by GUSTO criteria
  • Severe bleeding in Global Utilization Of Streptokinase And Tpa For Occluded Arteries (GUSTO) criteria [ Time Frame: 12 months ]
    Severe bleeding defined by GUSTO criteria
  • Moderate bleeding in Global Utilization Of Streptokinase And Tpa For Occluded Arteries (GUSTO) criteria [ Time Frame: 1 month ]
    Moderate bleeding defined by GUSTO criteria
  • Moderate bleeding in Global Utilization Of Streptokinase And Tpa For Occluded Arteries (GUSTO) criteria [ Time Frame: 12 months ]
    Moderate bleeding defined by GUSTO criteria
  • Moderate or severe bleeding in Global Utilization Of Streptokinase And Tpa For Occluded Arteries (GUSTO) criteria [ Time Frame: 1 month ]
    Moderate or severe bleeding defined by GUSTO criteria
  • Moderate or severe bleeding in Global Utilization Of Streptokinase And Tpa For Occluded Arteries (GUSTO) criteria [ Time Frame: 12 months ]
    Moderate or severe bleeding defined by GUSTO criteria
  • Intracranial bleeding [ Time Frame: 1 month ]
    Intracranial bleeding regardless of spontaneous or trauma
  • Intracranial bleeding [ Time Frame: 12 months ]
    Intracranial bleeding regardless of spontaneous or trauma
  • Gastrointestinal bleeding [ Time Frame: 1 month ]
    Bleeding from gastrointestinal tract regardless of severity
  • Gastrointestinal bleeding [ Time Frame: 12 months ]
    Bleeding from gastrointestinal tract regardless of severity
  • Gastrointestinal complaints [ Time Frame: 1 month ]
    Requirement of upper gastric fiberscopy to examine the gastrointestinal complaints
  • Gastrointestinal complaints [ Time Frame: 12 months ]
    Requirement of upper gastric fiberscopy to examine the gastrointestinal complaints
Original Secondary Outcome Measures  ICMJE
 (submitted: October 23, 2020)
  • Death [ Time Frame: 1 month ]
    Death from any cause
  • Death [ Time Frame: 12 months ]
    Death from any cause
  • Cardiovascular death [ Time Frame: 1 month ]
    Death from cardiac or vascular disease
  • Cardiovascular death [ Time Frame: 12 months ]
    Death from cardiac or vascular disease
  • Myocardial infarction [ Time Frame: 1 month ]
    Defined by arterial revascularization therapies study (ARTS) criteria
  • Myocardial infarction [ Time Frame: 12 months ]
    Defined by arterial revascularization therapies study (ARTS) criteria
  • Stroke [ Time Frame: 1 month ]
    Including both ischemic and heamorrhagic stroke
  • Stroke [ Time Frame: 12 months ]
    Including both ischemic and heamorrhagic stroke
  • Ischemic stroke [ Time Frame: 1 month ]
    Ischemic stroke with symptom lasting over 24 hours
  • Ischemic stroke [ Time Frame: 12 months ]
    Ischemic stroke with symptom lasting over 24 hours
  • Hemorrhagic stroke [ Time Frame: 1 month ]
    Intracerebral hemorrhage or subarchnoidal hemorrhage not associated with trauma
  • Hemorrhagic stroke [ Time Frame: 12 months ]
    Intracerebral hemorrhage or subarchnoidal hemorrhage not associated with trauma
  • Stent thrombosis [ Time Frame: 1 month ]
    Stent thrombosis defined by Academic Research Consortium definition
  • Stent thrombosis [ Time Frame: 12 months ]
    Stent thrombosis defined by Academic Research Consortium definition
  • Target lesion failure [ Time Frame: 1 month ]
    The angiographical confirmation of the restnosis of the target lesions
  • Target lesion failure [ Time Frame: 12 months ]
    The angiographical confirmation of the restnosis of the target lesions
  • Target vessel failure [ Time Frame: 1 month ]
    The angiographical confirmation of the restnosis or new lesion(s) of the target vessels or myocardial infarction involving the teritory of target vessels
  • Target vessel failure [ Time Frame: 12 months ]
    The angiographical confirmation of the restnosis or new lesion(s) of the target vessels or myocardial infarction involving the teritory of target vessels
  • Any target lesion revascularization [ Time Frame: 1 month ]
    Revascularization to the target lesions (including 5mm of both ends of the stent(s)) regardless of PCI or CABG
  • Any target lesion revascularization [ Time Frame: 12 months ]
    Revascularization to the target lesions (including 5mm of both ends of the stent(s)) regardless of PCI or CABG
  • Clinically-driven target lesion revascularization [ Time Frame: 1 month ]
    Target lesion revascularization with the anginal symptoms or the positive test for ischemia
  • Clinically-driven target lesion revascularization [ Time Frame: 12 months ]
    Target lesion revascularization with the anginal symptoms or the positive test for ischemia
  • Non-target lesions revascularization [ Time Frame: 1 month ]
    Revascularization to non-target lesions regardlesspercutaneous coronary intervention or coronary artery bypass grafting
  • Non-target lesions revascularization [ Time Frame: 12 months ]
    Revascularization to non-target lesions regardless percutaneous coronary intervention or coronary artery bypass grafting
  • Coronary artery bypass grafting [ Time Frame: 1 month ]
    Any coronary artery bypass grafting
  • Coronary artery bypass grafting [ Time Frame: 12 months ]
    Any coronary artery bypass grafting
  • Any target vessel revascularization [ Time Frame: 1 month ]
    Revascularization to the target vessel
  • Any target vessel revascularization [ Time Frame: 12 months ]
    Revascularization to the target vessel
  • Any coronary revascularization [ Time Frame: 1 month ]
    Revascularization regardless of percutaneous coronary intervention or coronary artery bypass grafting
  • Any coronary revascularization [ Time Frame: 12 months ]
    Revascularization regardless of percutaneous coronary intervention or coronary artery bypass grafting
  • Type 2 bleeding in Bleeding Academic Research Consortium (BARC) criteria [ Time Frame: 1 month ]
    Type 2 bleeding defined by BARC criteria
  • Type 2 bleeding in Bleeding Academic Research Consortium (BARC) criteria [ Time Frame: 12 months ]
    Type 2 bleeding defined by BARC criteria
  • Type 3 bleeding in Bleeding Academic Research Consortium (BARC) criteria [ Time Frame: 1 month ]
    Type 3 bleeding defined by BARC criteria
  • Type 3 bleeding in Bleeding Academic Research Consortium (BARC) criteria [ Time Frame: 12 months ]
    Type 3 bleeding defined by BARC criteria
  • Type 4 bleeding in Bleeding Academic Research Consortium (BARC) criteria [ Time Frame: 1 month ]
    Type 4 bleeding defined by BARC criteria
  • Type 4 bleeding in Bleeding Academic Research Consortium (BARC) criteria [ Time Frame: 12 months ]
    Type 4 bleeding defined by BARC criteria
  • Type 5 bleeding in Bleeding Academic Research Consortium (BARC) criteria [ Time Frame: 1 month ]
    Type 5 bleeding defined by BARC criteria
  • Type 5 bleeding in Bleeding Academic Research Consortium (BARC) criteria [ Time Frame: 12 months ]
    Type 5 bleeding defined by BARC criteria
  • Type 2, 3, or 5 bleeding in Bleeding Academic Research Consortium (BARC) criteria [ Time Frame: 1 month ]
    Type 2, 3, or 5 bleeding defined by BARC criteria
  • Type 2, 3, or 5 bleeding in Bleeding Academic Research Consortium (BARC) criteria [ Time Frame: 12 months ]
    Type 2, 3, or 5 bleeding defined by BARC criteria
  • Major bleeding in Thrombolysis in Myocardial Infarction (TIMI) criteria [ Time Frame: 1 month ]
    Major bleeding defined by TIMI criteria
  • Major bleeding in Thrombolysis in Myocardial Infarction (TIMI) criteria [ Time Frame: 12 months ]
    Major bleeding defined by TIMI criteria
  • Minor bleeding in Thrombolysis in Myocardial Infarction (TIMI) criteria [ Time Frame: 1 month ]
    Minor bleeding defined by TIMI criteria
  • Minor bleeding in Thrombolysis in Myocardial Infarction (TIMI) criteria [ Time Frame: 12 months ]
    Minor bleeding defined by TIMI criteria
  • Major or minor bleeding in Thrombolysis in Myocardial Infarction (TIMI) criteria [ Time Frame: 1 month ]
    Major or minor defined by TIMI criteria
  • Major or minor bleeding in Thrombolysis in Myocardial Infarction (TIMI) criteria [ Time Frame: 12 months ]
    Major or minor defined by TIMI criteria
  • Severe bleeding in Global Utilization Of Streptokinase And Tpa For Occluded Arteries (GUSTO) criteria [ Time Frame: 1 month ]
    Severe bleeding defined by GUSTO criteria
  • Severe bleeding in Global Utilization Of Streptokinase And Tpa For Occluded Arteries (GUSTO) criteria [ Time Frame: 12 months ]
    Severe bleeding defined by GUSTO criteria
  • Moderate bleeding in Global Utilization Of Streptokinase And Tpa For Occluded Arteries (GUSTO) criteria [ Time Frame: 1 month ]
    Moderate bleeding defined by GUSTO criteria
  • Moderate bleeding in Global Utilization Of Streptokinase And Tpa For Occluded Arteries (GUSTO) criteria [ Time Frame: 12 months ]
    Moderate bleeding defined by GUSTO criteria
  • Moderate or severe bleeding in Global Utilization Of Streptokinase And Tpa For Occluded Arteries (GUSTO) criteria [ Time Frame: 1 month ]
    Moderate or severe bleeding defined by GUSTO criteria
  • Moderate or severe bleeding in Global Utilization Of Streptokinase And Tpa For Occluded Arteries (GUSTO) criteria [ Time Frame: 12 months ]
    Moderate or severe bleeding defined by GUSTO criteria
  • Intracranial bleeding [ Time Frame: 1 month ]
    Intracranial bleeding regardless of spontaneous or trauma
  • Intracranial bleeding [ Time Frame: 12 months ]
    Intracranial bleeding regardless of spontaneous or trauma
  • Gastrointestinal bleeding [ Time Frame: 1 month ]
    Bleeding from gastrointestinal tract regardless of severity
  • Gastrointestinal bleeding [ Time Frame: 12 months ]
    Bleeding from gastrointestinal tract regardless of severity
  • Gastrointestinal complaints [ Time Frame: 1 month ]
    Requirement of upper gastric fiberscopy to examine the gastrointestinal complaints
  • Gastrointestinal complaints [ Time Frame: 12 months ]
    Requirement of upper gastric fiberscopy to examine the gastrointestinal complaints
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ShorT and OPtimal Duration of Dual AntiPlatelet Therapy-3 Study
Official Title  ICMJE ShorT and OPtimal Duration of Dual AntiPlatelet Therapy Study After Everolimus-eluting Cobalt-chromium Stent-3
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acute Coronary Syndrome
Intervention  ICMJE
  • Drug: No aspirin
    1-month prasugrel monotherapy followed by clopidogrel monotherapy
  • Drug: 1-month DAPT
    1-month dual antiplatelet therapy comprising of aspirin and prasugrel followed by aspirin monotherapy
Study Arms  ICMJE
  • 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.
    Intervention: Drug: No aspirin
  • 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.
    Intervention: Drug: 1-month DAPT
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: June 17, 2023)		 6002
Original Estimated Enrollment  ICMJE
 (submitted: October 23, 2020)		 3110
Estimated Study Completion Date  ICMJE December 31, 2025
Estimated Primary Completion Date December 31, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04609111
Other Study ID Numbers  ICMJE Y0080
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Takeshi Morimoto, Kyoto University, Graduate School of Medicine
Original Responsible Party Takeshi Morimoto, Kyoto University, Graduate School of Medicine, Professor of Medicine
Current Study Sponsor  ICMJE Kyoto University, Graduate School of Medicine
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Takeshi Kimura, MD Kyoto University, Graduate School of Medicine
PRS Account Kyoto University, Graduate School of Medicine
Verification Date June 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP