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

Sponsor
Kyoto University, Graduate School of Medicine (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03462498
Collaborator
(none)
3,008
1
2
95.9
31.4

Study Details

Study Description

Brief 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).

Condition or Disease Intervention/Treatment Phase
  • Drug: 1-months DAPT
  • Drug: 12-month DAPT
Phase 4

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
3008 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Study to Evaluate the Safety of Reducing Dual Antiplatelet Therapy (DAPT) Duration to 1 Month for Patients With Acute Coronary Syndrome (ACS) After Implantation of Everolimus-eluting Cobalt-chromium Stent
Actual Study Start Date :
Apr 2, 2018
Anticipated Primary Completion Date :
Mar 31, 2025
Anticipated Study Completion Date :
Mar 31, 2026

Arms and Interventions

Arm Intervention/Treatment
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
1-month DAPT followed by 59-month monotherapy

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
12-month DAPT followed by 48-month monotherapy

Outcome Measures

Primary Outcome Measures

  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 [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 [60 months]

Secondary Outcome Measures

  1. Composite event of cardiovascular death/myocardial infarction/definite stent thrombosis/stroke [12 months]

  2. Composite event of cardiovascular death/myocardial infarction/definite stent thrombosis/stroke [60 months]

  3. Bleeding defined as major or minor under the definition of Thrombolysis in Myocardial Infarction (TIMI) Study group [12 months]

  4. Bleeding defined as major or minor under the definition of Thrombolysis in Myocardial Infarction (TIMI) Study group [60 months]

  5. Upper gastrointestinal endoscopic examination or treatment [60 months]

  6. Composite event of all-cause death/myocardial infarction [12 months]

  7. Composite event of all-cause death/myocardial infarction [60 months]

  8. All-cause death [12 months]

  9. All-cause death [60 months]

  10. Composite event of cardiovascular death/myocardial infarction [12 months]

  11. Composite event of cardiovascular death/myocardial infarction [60 months]

  12. Cardiovascular death [12 months]

  13. Cardiovascular death [60 months]

  14. Myocardial infarction [12 months]

  15. Myocardial infarction [60 months]

  16. Stroke [12 months]

  17. Stroke [60 months]

  18. Definite stent thrombosis [12 months]

    Academic Research Consortium definition

  19. Definite stent thrombosis [60 months]

    Academic Research Consortium definition

  20. Target lesion failure [12 months]

  21. Target lesion failure [60 months]

  22. Target vessel failure [12 months]

  23. Target vessel failure [60 months]

  24. Major adverse cardiac event [12 months]

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

  25. Major adverse cardiac event [60 months]

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

  26. Target lesion revascularization [12 months]

  27. Target lesion revascularization [60 months]

  28. Clinically-driven target lesion revascularization [12 months]

  29. Clinically-driven target lesion revascularization [60 months]

  30. Non target lesion revascularization [12 months]

  31. Non target lesion revascularization [60 months]

  32. Coronary artery bypass graft [12 months]

  33. Coronary artery bypass graft [60 months]

  34. Target vessel revascularization [12 months]

  35. Target vessel revascularization [60 months]

  36. Any coronary revascularization [12 months]

  37. Any coronary revascularization [60 months]

  38. Bleeding complications [12 months]

  39. Bleeding complications [60 months]

  40. Gastrointestinal bleeding [12 months]

  41. Gastrointestinal bleeding [60 months]

  42. Gastrointestinal complaints requiring upper gastrointestinal endoscopy [12 months]

  43. Gastrointestinal complaints requiring upper gastrointestinal endoscopy [60 months]

  44. Newly diagnosed cancer [60 months]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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:
  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Kyoto University Graduate School of Medicine Kyoto Japan 606-8507

Sponsors and Collaborators

  • Kyoto University, Graduate School of Medicine

Investigators

  • Principal Investigator: Takeshi Kimura, MD, Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Takeshi Morimoto, Professor of Medicine, Kyoto University, Graduate School of Medicine
ClinicalTrials.gov Identifier:
NCT03462498
Other Study ID Numbers:
  • C1348
First Posted:
Mar 12, 2018
Last Update Posted:
Jan 10, 2022
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Takeshi Morimoto, Professor of Medicine, Kyoto University, Graduate School of Medicine
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 10, 2022