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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome Drug: No aspirin Drug: 1-month DAPT Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6002 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: ShorT and OPtimal Duration of Dual AntiPlatelet Therapy Study After Everolimus-eluting Cobalt-chromium Stent-3
Actual Study Start Date : January 29, 2021
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Major bleeding [ Time Frame: 1 month ]
    Bleeding defined as BARC criteria 3 or 5

  2. Cardiovascular composite endpoint [ Time Frame: 1 month ]
    Composite of cardiovascular death, myocardial infarction, ischemic stroke ,or definite stent thrombosis


Secondary Outcome Measures :
  1. Death [ Time Frame: 1 month ]
    Death from any cause

  2. Death [ Time Frame: 12 months ]
    Death from any cause

  3. Cardiovascular death [ Time Frame: 1 month ]
    Death from cardiac or vascular disease

  4. Cardiovascular death [ Time Frame: 12 months ]
    Death from cardiac or vascular disease

  5. Myocardial infarction [ Time Frame: 1 month ]
    Defined by arterial revascularization therapies study (ARTS) criteria

  6. Myocardial infarction [ Time Frame: 12 months ]
    Defined by arterial revascularization therapies study (ARTS) criteria

  7. Stroke [ Time Frame: 1 month ]
    Including both ischemic and hemorrhagic stroke

  8. Stroke [ Time Frame: 12 months ]
    Including both ischemic and hemorrhagic stroke

  9. Ischemic stroke [ Time Frame: 1 month ]
    Ischemic stroke with symptom lasting over 24 hours

  10. Ischemic stroke [ Time Frame: 12 months ]
    Ischemic stroke with symptom lasting over 24 hours

  11. Hemorrhagic stroke [ Time Frame: 1 month ]
    Intracerebral hemorrhage or subarachnoidal hemorrhage not associated with trauma

  12. Hemorrhagic stroke [ Time Frame: 12 months ]
    Intracerebral hemorrhage or subarachnoidal hemorrhage not associated with trauma

  13. Stent thrombosis [ Time Frame: 1 month ]
    Stent thrombosis defined by Academic Research Consortium definition

  14. Stent thrombosis [ Time Frame: 12 months ]
    Stent thrombosis defined by Academic Research Consortium definition

  15. Target lesion failure [ Time Frame: 1 month ]
    The angiographical confirmation of the restenosis of the target lesions

  16. Target lesion failure [ Time Frame: 12 months ]
    The angiographical confirmation of the restenosis of the target lesions

  17. 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

  18. 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

  19. 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

  20. 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

  21. Clinically-driven target lesion revascularization [ Time Frame: 1 month ]
    Target lesion revascularization with the anginal symptoms or the positive test for ischemia

  22. Clinically-driven target lesion revascularization [ Time Frame: 12 months ]
    Target lesion revascularization with the anginal symptoms or the positive test for ischemia

  23. Non-target lesions revascularization [ Time Frame: 1 month ]
    Revascularization to non-target lesions regardless percutaneous coronary intervention or coronary artery bypass grafting

  24. Non-target lesions revascularization [ Time Frame: 12 months ]
    Revascularization to non-target lesions regardless percutaneous coronary intervention or coronary artery bypass grafting

  25. Coronary artery bypass grafting [ Time Frame: 1 month ]
    Any coronary artery bypass grafting

  26. Coronary artery bypass grafting [ Time Frame: 12 months ]
    Any coronary artery bypass grafting

  27. Any target vessel revascularization [ Time Frame: 1 month ]
    Revascularization to the target vessel

  28. Any target vessel revascularization [ Time Frame: 12 months ]
    Revascularization to the target vessel

  29. Any coronary revascularization [ Time Frame: 1 month ]
    Revascularization regardless of percutaneous coronary intervention or coronary artery bypass grafting

  30. Any coronary revascularization [ Time Frame: 12 months ]
    Revascularization regardless of percutaneous coronary intervention or coronary artery bypass grafting

  31. Type 2 bleeding in Bleeding Academic Research Consortium (BARC) criteria [ Time Frame: 1 month ]
    Type 2 bleeding defined by BARC criteria

  32. Type 2 bleeding in Bleeding Academic Research Consortium (BARC) criteria [ Time Frame: 12 months ]
    Type 2 bleeding defined by BARC criteria

  33. Type 3 bleeding in Bleeding Academic Research Consortium (BARC) criteria [ Time Frame: 1 month ]
    Type 3 bleeding defined by BARC criteria

  34. Type 3 bleeding in Bleeding Academic Research Consortium (BARC) criteria [ Time Frame: 12 months ]
    Type 3 bleeding defined by BARC criteria

  35. Type 4 bleeding in Bleeding Academic Research Consortium (BARC) criteria [ Time Frame: 1 month ]
    Type 4 bleeding defined by BARC criteria

  36. Type 4 bleeding in Bleeding Academic Research Consortium (BARC) criteria [ Time Frame: 12 months ]
    Type 4 bleeding defined by BARC criteria

  37. Type 5 bleeding in Bleeding Academic Research Consortium (BARC) criteria [ Time Frame: 1 month ]
    Type 5 bleeding defined by BARC criteria

  38. Type 5 bleeding in Bleeding Academic Research Consortium (BARC) criteria [ Time Frame: 12 months ]
    Type 5 bleeding defined by BARC criteria

  39. 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

  40. 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

  41. Major bleeding in Thrombolysis in Myocardial Infarction (TIMI) criteria [ Time Frame: 1 month ]
    Major bleeding defined by TIMI criteria

  42. Major bleeding in Thrombolysis in Myocardial Infarction (TIMI) criteria [ Time Frame: 12 months ]
    Major bleeding defined by TIMI criteria

  43. Minor bleeding in Thrombolysis in Myocardial Infarction (TIMI) criteria [ Time Frame: 1 month ]
    Minor bleeding defined by TIMI criteria

  44. Minor bleeding in Thrombolysis in Myocardial Infarction (TIMI) criteria [ Time Frame: 12 months ]
    Minor bleeding defined by TIMI criteria

  45. Major or minor bleeding in Thrombolysis in Myocardial Infarction (TIMI) criteria [ Time Frame: 1 month ]
    Major or minor defined by TIMI criteria

  46. Major or minor bleeding in Thrombolysis in Myocardial Infarction (TIMI) criteria [ Time Frame: 12 months ]
    Major or minor defined by TIMI criteria

  47. Severe bleeding in Global Utilization Of Streptokinase And Tpa For Occluded Arteries (GUSTO) criteria [ Time Frame: 1 month ]
    Severe bleeding defined by GUSTO criteria

  48. Severe bleeding in Global Utilization Of Streptokinase And Tpa For Occluded Arteries (GUSTO) criteria [ Time Frame: 12 months ]
    Severe bleeding defined by GUSTO criteria

  49. Moderate bleeding in Global Utilization Of Streptokinase And Tpa For Occluded Arteries (GUSTO) criteria [ Time Frame: 1 month ]
    Moderate bleeding defined by GUSTO criteria

  50. Moderate bleeding in Global Utilization Of Streptokinase And Tpa For Occluded Arteries (GUSTO) criteria [ Time Frame: 12 months ]
    Moderate bleeding defined by GUSTO criteria

  51. 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

  52. 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

  53. Intracranial bleeding [ Time Frame: 1 month ]
    Intracranial bleeding regardless of spontaneous or trauma

  54. Intracranial bleeding [ Time Frame: 12 months ]
    Intracranial bleeding regardless of spontaneous or trauma

  55. Gastrointestinal bleeding [ Time Frame: 1 month ]
    Bleeding from gastrointestinal tract regardless of severity

  56. Gastrointestinal bleeding [ Time Frame: 12 months ]
    Bleeding from gastrointestinal tract regardless of severity

  57. Gastrointestinal complaints [ Time Frame: 1 month ]
    Requirement of upper gastric fiberscopy to examine the gastrointestinal complaints

  58. Gastrointestinal complaints [ Time Frame: 12 months ]
    Requirement of upper gastric fiberscopy to examine the gastrointestinal complaints


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04609111


Locations
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Japan
Kyoto University Graduate School of Medicine
Kyoto, Japan, 606-8507
Sponsors and Collaborators
Kyoto University, Graduate School of Medicine
Investigators
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Principal Investigator: Takeshi Kimura, MD Kyoto University, Graduate School of Medicine
More Information
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Responsible Party: Takeshi Morimoto, Study Statistician, Kyoto University, Graduate School of Medicine
ClinicalTrials.gov Identifier: NCT04609111    
Other Study ID Numbers: Y0080
First Posted: October 30, 2020    Key Record Dates
Last Update Posted: June 22, 2023
Last Verified: June 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Takeshi Morimoto, Kyoto University, Graduate School of Medicine:
stent
percutaneous coronary transluminal angioplasty
bleeding
antiplatelet agents
Additional relevant MeSH terms:
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Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics