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Acute Coronary SyndromePhase 4STOPDAPT-3NCT04609111

ShorT and OPtimal Duration of Dual AntiPlatelet Therapy-3 Study

A Phase 4 study testing No aspirin and 1-month DAPT in people with Acute Coronary Syndrome, run by Kyoto University, Graduate School of Medicine at 1 site in Japan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

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)… Read more about this study

Who is it for?
Any age
Conditions the study is for
Acute Coronary Syndrome
What is being tested?
No aspirin and 1-month DAPT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6,002 participants
Where
1 siteJapan
Study dates
29 Jan 2021to 31 Dec 2025
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Japan1 site

  • Kyoto University Graduate School of Medicine

    Kyoto, 606-8507

Other trials in Japan

About this study

Official title: 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.

Read the 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.

Being tested
No aspirin, 1-month DAPT
Keywords
stent, percutaneous coronary transluminal angioplasty, bleeding, antiplatelet agents
Medical subject headings
Acute Coronary Syndrome, Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No aspirinDrug

    1-month prasugrel monotherapy followed by clopidogrel monotherapy

  • 1-month DAPTDrug

    1-month dual antiplatelet therapy comprising of aspirin and prasugrel followed by aspirin monotherapy

Study groups in NCT04609111
Study groupRoleWhat they receive
No aspirinActive comparatorTo start prasugrel monotherapy before the index percutaneous coronary intervention (PCI) and to change into clopidogrel monotherapy at 1-month after the PCI.
Receives: Drug: No aspirin
1-month DAPTActive comparatorTo 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.
Receives: Drug: 1-month DAPT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Major bleeding

    Bleeding defined as BARC criteria 3 or 5

    Measured: 1 month

  2. Cardiovascular composite endpoint

    Composite of cardiovascular death, myocardial infarction, ischemic stroke ,or definite stent thrombosis

    Measured: 1 month

Secondary outcomes (58)

  1. Death

    Death from any cause

    Measured: 1 month

  2. Death

    Death from any cause

    Measured: 12 months

  3. Cardiovascular death

    Death from cardiac or vascular disease

    Measured: 1 month

  4. Cardiovascular death

    Death from cardiac or vascular disease

    Measured: 12 months

  5. Myocardial infarction

    Defined by arterial revascularization therapies study (ARTS) criteria

    Measured: 1 month

  6. Myocardial infarction

    Defined by arterial revascularization therapies study (ARTS) criteria

    Measured: 12 months

  7. Stroke

    Including both ischemic and hemorrhagic stroke

    Measured: 1 month

  8. Stroke

    Including both ischemic and hemorrhagic stroke

    Measured: 12 months

  9. Ischemic stroke

    Ischemic stroke with symptom lasting over 24 hours

    Measured: 1 month

  10. Ischemic stroke

    Ischemic stroke with symptom lasting over 24 hours

    Measured: 12 months

  11. Hemorrhagic stroke

    Intracerebral hemorrhage or subarachnoidal hemorrhage not associated with trauma

    Measured: 1 month

  12. Hemorrhagic stroke

    Intracerebral hemorrhage or subarachnoidal hemorrhage not associated with trauma

    Measured: 12 months

  13. Stent thrombosis

    Stent thrombosis defined by Academic Research Consortium definition

    Measured: 1 month

  14. Stent thrombosis

    Stent thrombosis defined by Academic Research Consortium definition

    Measured: 12 months

  15. Target lesion failure

    The angiographical confirmation of the restenosis of the target lesions

    Measured: 1 month

  16. Target lesion failure

    The angiographical confirmation of the restenosis of the target lesions

    Measured: 12 months

  17. 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

    Measured: 1 month

  18. 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

    Measured: 12 months

  19. 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

    Measured: 1 month

  20. 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

    Measured: 12 months

  21. Clinically-driven target lesion revascularization

    Target lesion revascularization with the anginal symptoms or the positive test for ischemia

    Measured: 1 month

  22. Clinically-driven target lesion revascularization

    Target lesion revascularization with the anginal symptoms or the positive test for ischemia

    Measured: 12 months

  23. Non-target lesions revascularization

    Revascularization to non-target lesions regardless percutaneous coronary intervention or coronary artery bypass grafting

    Measured: 1 month

  24. Non-target lesions revascularization

    Revascularization to non-target lesions regardless percutaneous coronary intervention or coronary artery bypass grafting

    Measured: 12 months

  25. Coronary artery bypass grafting

    Any coronary artery bypass grafting

    Measured: 1 month

  26. Coronary artery bypass grafting

    Any coronary artery bypass grafting

    Measured: 12 months

  27. Any target vessel revascularization

    Revascularization to the target vessel

    Measured: 1 month

  28. Any target vessel revascularization

    Revascularization to the target vessel

    Measured: 12 months

  29. Any coronary revascularization

    Revascularization regardless of percutaneous coronary intervention or coronary artery bypass grafting

    Measured: 1 month

  30. Any coronary revascularization

    Revascularization regardless of percutaneous coronary intervention or coronary artery bypass grafting

    Measured: 12 months

  31. Type 2 bleeding in Bleeding Academic Research Consortium (BARC) criteria

    Type 2 bleeding defined by BARC criteria

    Measured: 1 month

  32. Type 2 bleeding in Bleeding Academic Research Consortium (BARC) criteria

    Type 2 bleeding defined by BARC criteria

    Measured: 12 months

  33. Type 3 bleeding in Bleeding Academic Research Consortium (BARC) criteria

    Type 3 bleeding defined by BARC criteria

    Measured: 1 month

  34. Type 3 bleeding in Bleeding Academic Research Consortium (BARC) criteria

    Type 3 bleeding defined by BARC criteria

    Measured: 12 months

  35. Type 4 bleeding in Bleeding Academic Research Consortium (BARC) criteria

    Type 4 bleeding defined by BARC criteria

    Measured: 1 month

  36. Type 4 bleeding in Bleeding Academic Research Consortium (BARC) criteria

    Type 4 bleeding defined by BARC criteria

    Measured: 12 months

  37. Type 5 bleeding in Bleeding Academic Research Consortium (BARC) criteria

    Type 5 bleeding defined by BARC criteria

    Measured: 1 month

  38. Type 5 bleeding in Bleeding Academic Research Consortium (BARC) criteria

    Type 5 bleeding defined by BARC criteria

    Measured: 12 months

  39. Type 2, 3, or 5 bleeding in Bleeding Academic Research Consortium (BARC) criteria

    Type 2, 3, or 5 bleeding defined by BARC criteria

    Measured: 1 month

  40. Type 2, 3, or 5 bleeding in Bleeding Academic Research Consortium (BARC) criteria

    Type 2, 3, or 5 bleeding defined by BARC criteria

    Measured: 12 months

  41. Major bleeding in Thrombolysis in Myocardial Infarction (TIMI) criteria

    Major bleeding defined by TIMI criteria

    Measured: 1 month

  42. Major bleeding in Thrombolysis in Myocardial Infarction (TIMI) criteria

    Major bleeding defined by TIMI criteria

    Measured: 12 months

  43. Minor bleeding in Thrombolysis in Myocardial Infarction (TIMI) criteria

    Minor bleeding defined by TIMI criteria

    Measured: 1 month

  44. Minor bleeding in Thrombolysis in Myocardial Infarction (TIMI) criteria

    Minor bleeding defined by TIMI criteria

    Measured: 12 months

  45. Major or minor bleeding in Thrombolysis in Myocardial Infarction (TIMI) criteria

    Major or minor defined by TIMI criteria

    Measured: 1 month

  46. Major or minor bleeding in Thrombolysis in Myocardial Infarction (TIMI) criteria

    Major or minor defined by TIMI criteria

    Measured: 12 months

  47. Severe bleeding in Global Utilization Of Streptokinase And Tpa For Occluded Arteries (GUSTO) criteria

    Severe bleeding defined by GUSTO criteria

    Measured: 1 month

  48. Severe bleeding in Global Utilization Of Streptokinase And Tpa For Occluded Arteries (GUSTO) criteria

    Severe bleeding defined by GUSTO criteria

    Measured: 12 months

  49. Moderate bleeding in Global Utilization Of Streptokinase And Tpa For Occluded Arteries (GUSTO) criteria

    Moderate bleeding defined by GUSTO criteria

    Measured: 1 month

  50. Moderate bleeding in Global Utilization Of Streptokinase And Tpa For Occluded Arteries (GUSTO) criteria

    Moderate bleeding defined by GUSTO criteria

    Measured: 12 months

  51. Moderate or severe bleeding in Global Utilization Of Streptokinase And Tpa For Occluded Arteries (GUSTO) criteria

    Moderate or severe bleeding defined by GUSTO criteria

    Measured: 1 month

  52. Moderate or severe bleeding in Global Utilization Of Streptokinase And Tpa For Occluded Arteries (GUSTO) criteria

    Moderate or severe bleeding defined by GUSTO criteria

    Measured: 12 months

  53. Intracranial bleeding

    Intracranial bleeding regardless of spontaneous or trauma

    Measured: 1 month

  54. Intracranial bleeding

    Intracranial bleeding regardless of spontaneous or trauma

    Measured: 12 months

  55. Gastrointestinal bleeding

    Bleeding from gastrointestinal tract regardless of severity

    Measured: 1 month

  56. Gastrointestinal bleeding

    Bleeding from gastrointestinal tract regardless of severity

    Measured: 12 months

  57. Gastrointestinal complaints

    Requirement of upper gastric fiberscopy to examine the gastrointestinal complaints

    Measured: 1 month

  58. Gastrointestinal complaints

    Requirement of upper gastric fiberscopy to examine the gastrointestinal complaints

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Oct 2020
  2. Study start29 Jan 2021
  3. Primary completion31 Dec 2023
  4. Study completion31 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
6,002 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04609111
Sponsor's protocol ID
Y0080
Acronym
STOPDAPT-3
Status last verified
Jun 2024
First submitted
23 Oct 2020
Last updated
14 Jun 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Nishikura T, Yamamoto K, Wakabayashi K, Natsuaki M, Watanabe H, Morimoto T, Obayashi Y, Nishikawa R, Kimura T, Ando K, Suwa S, Isawa T, Takenaka H, Ishikawa T, Onishi Y, Hibi K, Kawai K, Murakami T, Takasaki A, Higashitani N, Nakano M, Ono K, Kimura T; STOPDAPT-3 investigators. Effect of Proton Pump Inhibitors in Patients Undergoing Percutaneous Coronary Intervention With Aspirin-Free Strategy. JACC Asia. 2026 Feb;6(2):128-140. doi: 10.1016/j.jacasi.2025.09.015. Epub 2025 Nov 26.

    PubMed 41307518

  • Natsuaki M, Watanabe H, Morimoto T, Yamamoto K, Obayashi Y, Nishikawa R, Kimura T, Ando K, Suwa S, Isawa T, Takenaka H, Ishikawa T, Tamura T, Kawahatsu K, Hayashi F, Akao M, Serikawa T, Mori H, Kawamura T, Hagikura A, Shibata N, Ono K, Kimura T. Aspirin Versus Clopidogrel Beyond 1 Month After PCI in Patients With Oral Anticoagulation. Circ Cardiovasc Interv. 2025 Nov;18(11):e015495. doi: 10.1161/CIRCINTERVENTIONS.125.015495. Epub 2025 Sep 24.

    PubMed 40988628

  • Obayashi Y, Natsuaki M, Watanabe H, Morimoto T, Yamamoto K, Nishikawa R, Kimura T, Ando K, Suwa S, Isawa T, Takenaka H, Ishikawa T, Tokuyama H, Sakamoto H, Fujita T, Nanasato M, Okayama H, Nishikura T, Kirigaya H, Nishida K, Ono K, Kimura T; STOPDAPT-3 Investigators. Aspirin vs Clopidogrel 1 Month After Acute Coronary Syndrome With High-Bleeding Risk or ST-Segment Elevation. JACC Cardiovasc Interv. 2025 Sep 8;18(17):2120-2135. doi: 10.1016/j.jcin.2025.03.029. Epub 2025 Jun 4.

    PubMed 40471776

  • Ishikawa T, Natsuaki M, Watanabe H, Morimoto T, Yamamoto K, Obayashi Y, Nishikawa R, Ando K, Suwa S, Isawa T, Takenaka H, Yoshida R, Suzuki H, Nakazawa G, Kusuyama T, Morishima I, Hojo S, Tsutsumi J, Yamamoto H, Ueda H, Ono K, Kimura T. Aspirin-Free Strategy for PCI in Patients With High Bleeding Risk With or Without Acute Coronary Syndrome: A Subgroup Analysis From the STOPDAPT-3 Trial. Circ Cardiovasc Interv. 2025 Jul;18(7):e015197. doi: 10.1161/CIRCINTERVENTIONS.124.015197. Epub 2025 May 14.

    PubMed 40365675

  • Domei T, Yamamoto K, Natsuaki M, Watanabe H, Morimoto T, Obayashi Y, Nishikawa R, Kimura T, Ando K, Suwa S, Isawa T, Takenaka H, Ishikawa T, Tamura T, Kawahatsu K, Hayashi F, Abe M, Serikawa T, Mori H, Kawamura T, Hagikura A, Shibata N, Ono K, Kimura T. Aspirin vs. clopidogrel monotherapy beyond 1 month after complex percutaneous coronary intervention: a pre-specified subgroup analysis of the STOPDAPT-3 trial. Eur Heart J Cardiovasc Pharmacother. 2025 Mar 13;11(2):198-209. doi: 10.1093/ehjcvp/pvaf002.

    PubMed 39863419

  • Watanabe H, Natsuaki M, Morimoto T, Yamamoto K, Obayashi Y, Nishikawa R, Kimura T, Ando K, Domei T, Suwa S, Ogita M, Isawa T, Takenaka H, Yamamoto T, Ishikawa T, Hisauchi I, Wakabayashi K, Onishi Y, Hibi K, Kawai K, Yoshida R, Suzuki H, Nakazawa G, Kusuyama T, Morishima I, Ono K, Kimura T. Aspirin vs. clopidogrel monotherapy after percutaneous coronary intervention: 1-year follow-up of the STOPDAPT-3 trial. Eur Heart J. 2024 Dec 16;45(47):5042-5054. doi: 10.1093/eurheartj/ehae617.

    PubMed 39215959

  • Watanabe H, Natsuaki M, Morimoto T, Yamamoto K, Obayashi Y, Nishikawa R, Hamatani Y, Ando K, Domei T, Suwa S, Ogita M, Isawa T, Takenaka H, Yamamoto T, Ishikawa T, Hisauchi I, Wakabayashi K, Onishi Y, Hibi K, Kawai K, Yoshida R, Suzuki H, Nakazawa G, Kusuyama T, Morishima I, Ono K, Kimura T; STOPDAPT-3 Investigators. Post-procedural Anticoagulation With Unfractionated Heparin in Acute Coronary Syndrome: Insight from the STOPDAPT-3 Trial. Am J Cardiol. 2024 Sep 1;226:83-96. doi: 10.1016/j.amjcard.2024.07.002. Epub 2024 Jul 6.

    PubMed 38972535

  • Yamamoto K, Natsuaki M, Watanabe H, Morimoto T, Obayashi Y, Nishikawa R, Ando K, Suwa S, Isawa T, Takenaka H, Ishikawa T, Tamura T, Kawahatsu K, Hayashi F, Akao M, Serikawa T, Mori H, Kawamura T, Hagikura A, Shibata N, Ono K, Kimura T; STOPDAPT-3 Investigators. An Aspirin-Free Strategy for Immediate Treatment Following Complex Percutaneous Coronary Intervention. JACC Cardiovasc Interv. 2024 May 13;17(9):1119-1130. doi: 10.1016/j.jcin.2024.03.017.

    PubMed 38749592

  • Natsuaki M, Watanabe H, Morimoto T, Yamamoto K, Obayashi Y, Nishikawa R, Ando K, Domei T, Suwa S, Ogita M, Isawa T, Takenaka H, Yamamoto T, Ishikawa T, Hisauchi I, Wakabayashi K, Onishi Y, Hibi K, Kawai K, Yoshida R, Suzuki H, Nakazawa G, Kusuyama T, Morishima I, Ono K, Kimura T. An Aspirin-Free Versus Dual Antiplatelet Strategy for Coronary Stenting: STOPDAPT-3 Randomized Trial. Circulation. 2024 Feb 20;149(8):585-600. doi: 10.1161/CIRCULATIONAHA.123.066720. Epub 2023 Nov 23.

    PubMed 37994553

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing No aspirin and 1-month DAPT in people with Acute Coronary Syndrome, run by Kyoto University, Graduate School of Medicine at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 14 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Major bleeding (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04609111, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2024.

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