ClinicalTrials.gg
Sign In
Active, not recruitingNCT03462498STOPDAPT-2 ACSUpdated Jun 14, 2024

ShorT and OPtimal Duration of Dual AntiPlatelet Therapy-2 Study for the Patients With ACS

A Phase 4 interventional study of 1-months DAPT and 12-month DAPT in Acute Coronary Syndrome, Acute Myocardial Infarction and Coronary Artery Disease, sponsored by Kyoto University, Graduate School of Medicine. Active, not recruiting at 1 site in Japan. Per ClinicalTrials.gov, last updated 2024-06-14.

Sponsored by Kyoto University, Graduate School of Medicine · Phase 4, Interventional, and Prevention

Phase
Phase 4
Study type
Interventional
Enrollment
3,008
Allocation
Randomized
Sex
All
01

Study summary

The purpose of this study is to evaluate the safety of reducing dual antiplatelet therapy (DAPT) duration to 1 month after implantation of the everolimus-eluting cobalt-chromium stent (CoCr-EES) under the setting of acute coronary syndrome (ACS).

Read the detailed description

The drug-eluting stents (DESs) are currently used in the majority of percutaneous coronary intervention (PCI) procedures. On the other hand, the problems of the first-generation DES (late adverse events, such as very late stent thrombosis) have been pointed out. Dual antiplatelet therapy (DAPT) has become a standard regimen after DES implantation and for fear of very late stent thrombosis, DAPT is frequently performed for 1 year or longer in clinical practice. Especially guidelines recommend 1-year DAPT for patients with acute coronary syndrome (ACS), though its rational is based on the study more than 15 years old. However, serious hemorrhagic complications associated with prolonged DAPT duration can bring disadvantages to patients, and it is extremely important to clarify an optimal DAPT duration after DES procedure. Currently, 1-month DAPT regimen after bare metal stent (BMS) implantation is commonly used in clinical practice, producing no major problems. Based on a meta-analysis of recent clinical studies, it has also been reported that the use of Cobalt-Chromium Everolimus-Eluting Stent (CoCr-EES) reduces the risk of early stent thrombosis by half compared to the use of BMS. There is no necessity to extend antiplatelet therapy after CoCr-EES implantation longer than after BMS implantation, and it is considered possible to use the same 1-month DAPT duration as after BMS implantation. The investigators already planned and started a multicenter, randomized, open-label, controlled study, in which the subjects who have undergone CoCr-EES procedure will be divided into the 1-month DAPT and clopidogrel monotherapy group and the 12-month DAPT and aspirin monotherapy group (STOPDAPT-2; NCT02619760), where primary endpoint is the incidence of composite events including cardiovascular death, myocardial infarction, stent thrombosis, stroke, and bleeding defined by TIMI major or minor bleeding. In STOPDAPT-2, the non-inferiority about primary endpoint of 1-month DAPT group will be evaluated at 12 months after index procedure and secondarily, the superiority about primary endpoint of 1-month DAPT group will be evaluated at 5 years after index procedure. The proportion of patients with ACS is about 30-40% in STOPDAPT-2 and the power is insufficient to evaluate the safety and efficacy of 1-month DAPT regimen specifically for patients with ACS. Therefore the investigators planned the current study to enroll patients of ACS with the same protocol as STOPDAPT-2.

02

Conditions studied

  • Acute Coronary Syndrome
  • Acute Myocardial Infarction
  • Coronary Artery Disease
  • Percutaneous Coronary Intervention
  • Platelet Aggregation Inhibitors

Keywords

  • Acute Coronary Syndrome
  • Acute Myocardial Infarction
  • Coronary Artery Disease
  • Percutaneous Coronary Intervention
  • Platelet Aggregation Inhibitors
03

In context

Acute Coronary Syndrome

1,488 studies on the registry are indexed under Acute Coronary Syndrome; 273 are open to participants now.

This study's enrollment of 3,008 is above the median of 200 across 865 interventional studies indexed under Acute Coronary Syndrome.

Browse Acute Coronary Syndrome studies →

Lead sponsor

Kyoto University, Graduate School of Medicine is the lead sponsor of 22 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients received percutaneous coronary intervention with cobalt-chromium everolimus-eluting stent under the setting of acute coronary syndrome
  • Patients who are capable of oral dual antiplatelet therapy consisting of aspirin and P2Y12 receptor antagonist

Exclusion criteria

Exclusion Criteria:

  • Patients requiring oral anticoagulants
  • Patients with medical history of intracranial hemorrhage
  • Patients who have experienced serious complications (myocardial infarction, stroke, and major bleeding) during hospital stay after percutaneous coronary intervention
  • Patients with drug eluting stents other than Cobalt chromium everolimus eluting stents implanted at the time of enrollment
  • Patients confirmed to have no tolerability to clopidogrel before enrollment
  • Patients requiring continuous administration of antiplatelet drugs other than aspirin and P2Y12 receptor antagonists at the time of enrollment
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
3,008 participants (actual)

Study arms

  • Active comparator
    1-month DAPT

    1-month dual antiplatelet therapy (DAPT) composed of aspirin and P2Y12 receptor antagonists and clopidogrel monotherapy for 59 months

    Drug: 1-months DAPT

  • Active comparator
    12-month DAPT

    1-month dual antiplatelet therapy (DAPT) composed of aspirin and P2Y12 receptor antagonists; 11-month DAPT composed of aspirin and clopidogrel and aspirin monotherapy for 48 months

    Drug: 12-month DAPT

Interventions

  • Drug1-months DAPT

    1-month DAPT followed by 59-month monotherapy

  • Drug12-month DAPT

    12-month DAPT followed by 48-month monotherapy

06

What researchers measure

Primary outcomes

  1. Composite event of cardiovascular death/myocardial infarction/definite stent thrombosis/stroke/bleeding defined as major or minor under the definition of Thrombolysis in Myocardial Infarction (TIMI) Study group

    Time frame: 12 months

  2. Composite event of cardiovascular death/myocardial infarction/definite stent thrombosis/stroke/bleeding defined as major or minor under the definition of Thrombolysis in Myocardial Infarction (TIMI) Study group

    Time frame: 60 months

Secondary outcomes

  1. Composite event of cardiovascular death/myocardial infarction/definite stent thrombosis/stroke

    Time frame: 12 months

  2. Composite event of cardiovascular death/myocardial infarction/definite stent thrombosis/stroke

    Time frame: 60 months

  3. Bleeding defined as major or minor under the definition of Thrombolysis in Myocardial Infarction (TIMI) Study group

    Time frame: 12 months

  4. Bleeding defined as major or minor under the definition of Thrombolysis in Myocardial Infarction (TIMI) Study group

    Time frame: 60 months

  5. Upper gastrointestinal endoscopic examination or treatment

    Time frame: 60 months

  6. Composite event of all-cause death/myocardial infarction

    Time frame: 12 months

  7. Composite event of all-cause death/myocardial infarction

    Time frame: 60 months

  8. All-cause death

    Time frame: 12 months

  9. All-cause death

    Time frame: 60 months

  10. Composite event of cardiovascular death/myocardial infarction

    Time frame: 12 months

  11. Composite event of cardiovascular death/myocardial infarction

    Time frame: 60 months

  12. Cardiovascular death

    Time frame: 12 months

  13. Cardiovascular death

    Time frame: 60 months

  14. Myocardial infarction

    Time frame: 12 months

  15. Myocardial infarction

    Time frame: 60 months

  16. Stroke

    Time frame: 12 months

  17. Stroke

    Time frame: 60 months

  18. Definite stent thrombosis

    Academic Research Consortium definition

    Time frame: 12 months

  19. Definite stent thrombosis

    Academic Research Consortium definition

    Time frame: 60 months

  20. Target lesion failure

    Time frame: 12 months

  21. Target lesion failure

    Time frame: 60 months

  22. Target vessel failure

    Time frame: 12 months

  23. Target vessel failure

    Time frame: 60 months

  24. Major adverse cardiac event

    Composite of cardiac death, myocardial infarction, and clinically-driven TLR

    Time frame: 12 months

  25. Major adverse cardiac event

    Composite of cardiac death, myocardial infarction, and clinically-driven TLR

    Time frame: 60 months

  26. Target lesion revascularization

    Time frame: 12 months

  27. Target lesion revascularization

    Time frame: 60 months

  28. Clinically-driven target lesion revascularization

    Time frame: 12 months

  29. Clinically-driven target lesion revascularization

    Time frame: 60 months

  30. Non target lesion revascularization

    Time frame: 12 months

  31. Non target lesion revascularization

    Time frame: 60 months

  32. Coronary artery bypass graft

    Time frame: 12 months

  33. Coronary artery bypass graft

    Time frame: 60 months

  34. Target vessel revascularization

    Time frame: 12 months

  35. Target vessel revascularization

    Time frame: 60 months

  36. Any coronary revascularization

    Time frame: 12 months

  37. Any coronary revascularization

    Time frame: 60 months

  38. Bleeding complications

    Time frame: 12 months

  39. Bleeding complications

    Time frame: 60 months

  40. Gastrointestinal bleeding

    Time frame: 12 months

  41. Gastrointestinal bleeding

    Time frame: 60 months

  42. Gastrointestinal complaints requiring upper gastrointestinal endoscopy

    Time frame: 12 months

  43. Gastrointestinal complaints requiring upper gastrointestinal endoscopy

    Time frame: 60 months

  44. Newly diagnosed cancer

    The endpoint is a newly diagnosed malignancy during the follow-up period that has not been previously diagnosed before enrollment. This does not include recurrent tumor after remission, includes early-stage cancer eligible for endoscopic treatment, and includes the tumors which are not diagnosed by tissue biopsy but are judged to be clinically malignant on imaging.

    Time frame: 60 months

07

Study locations

1 site
08

References and documents

Publications

  • Obayashi Y, Watanabe H, Morimoto T, Yamamoto K, Natsuaki M, Domei T, Yamaji K, Suwa S, Isawa T, Watanabe H, Yoshida R, Sakamoto H, Akao M, Hata Y, Morishima I, Tokuyama H, Yagi M, Suzuki H, Wakabayashi K, Suematsu N, Inada T, Tamura T, Okayama H, Abe M, Kawai K, Nakao K, Ando K, Tanabe K, Ikari Y, Morino Y, Kadota K, Furukawa Y, Nakagawa Y, Kimura T; STOPDAPT-2 and STOPDAPT-2 ACS Investigators. Clopidogrel Monotherapy After 1-Month Dual Antiplatelet Therapy in Percutaneous Coronary Intervention: From the STOPDAPT-2 Total Cohort. Circ Cardiovasc Interv. 2022 Aug;15(8):e012004. doi: 10.1161/CIRCINTERVENTIONS.122.012004. Epub 2022 Aug 1. PubMed 35912647 ↗
  • Watanabe H, Morimoto T, Natsuaki M, Yamamoto K, Obayashi Y, Ogita M, Suwa S, Isawa T, Domei T, Yamaji K, Tatsushima S, Watanabe H, Ohya M, Tokuyama H, Tada T, Sakamoto H, Mori H, Suzuki H, Nishikura T, Wakabayashi K, Hibi K, Abe M, Kawai K, Nakao K, Ando K, Tanabe K, Ikari Y, Morino Y, Kadota K, Furukawa Y, Nakagawa Y, Kimura T; STOPDAPT-2 ACS Investigators. Comparison of Clopidogrel Monotherapy After 1 to 2 Months of Dual Antiplatelet Therapy With 12 Months of Dual Antiplatelet Therapy in Patients With Acute Coronary Syndrome: The STOPDAPT-2 ACS Randomized Clinical Trial. JAMA Cardiol. 2022 Apr 1;7(4):407-417. doi: 10.1001/jamacardio.2021.5244. PubMed 35234821 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2018 to primary completion in Dec 2021, 44 months.

Of 85 non-industry phase 4 interventional studies under Acute Coronary Syndrome, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 27 and three quarters within 67. This study's 44 months is close to that.

Counting every sponsor, half of 92 studies reached it within 42 months; a quarter within 26 and three quarters within 60.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 6, 2018
First posted
Mar 12, 2018
StartActual
Apr 2, 2018
Primary completionActual
Dec 31, 2021
CompletionEst.
Mar 31, 2026
Last update
Jun 14, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 14, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03462498
Lead sponsor
Kyoto University, Graduate School of Medicine
Responsible party
Takeshi Morimoto (Professor of Medicine, Kyoto University, Graduate School of Medicine) — Principal investigator
First posted
Mar 12, 2018
Start date
Apr 2, 2018
Primary completion
Dec 31, 2021
Completion
Mar 31, 2026 (estimated)
Last update
Jun 14, 2024

Study contacts

Takeshi Kimura, MD
principal investigator · Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Acute Coronary Syndrome →

Other studies from this sponsor

Kyoto University, Graduate School of Medicine

Start the discussion