Skip to main content
OpenTrials
Completed

NCT Number: NCT02619760

ShorT and OPtimal Duration of Dual AntiPlatelet Therapy-2 Study

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Division of Cardiology, Kyoto University Hospital

Kyoto, 606-8507, Japan

About this study

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. However, serious hemorrhagic complications associated with a 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 therefore planned 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. 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. At first, 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients received percutaneous coronary intervention with cobalt-chromium everolimus-eluting stent
  • Patients who are capable of oral dual antiplatelet therapy consisting of asprin 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 (Xience) implanted at the time of enrollment
  • Patients comfirmed to have no tolerability to clopidgorel before enrollment
  • Patients requiring continuous administration of antiplaelet drugs other than aspirin and P2Y12 receptor antagonists at the time of enrollment
  • Patients with coronary bioabsorbable vascular scaffolds (BVS) implanted prior to or at the time of enrollment

Treatment and study plan

1-month DAPT

Drug

1-month dual antiplatelet therapy (DAPT) composed of aspirin and P2Y12 receptor antagonists

12-month DAPT

Drug

12-month dual antiplatelet therapy (DAPT) composed of aspirin and P2Y12 receptor antagonists

Primary outcomes

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

    Time frame: 12-month

    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

Secondary outcomes

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

    Time frame: 12-month

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

    Time frame: 60-month

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

    Time frame: 12-month

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

    Time frame: 60-month

  5. Upper gastrointestinal endoscopic examination or treatment

    Time frame: 60-month

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

    Time frame: 12-month

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

    Time frame: 60-month

  8. All-cause death

    Time frame: 12-month

  9. All-cause death

    Time frame: 60-month

  10. Composite event of cardiovascular death/myocardial infarction

    Time frame: 12-month

  11. Composite event of cardiovascular death/myocardial infarction

    Time frame: 60-month

  12. Cardiovascular death

    Time frame: 12-month

  13. Cardiovascular death

    Time frame: 60-month

  14. Myocardial infarction

    Time frame: 12-month

  15. Myocardial infarction

    Time frame: 60-month

  16. Stroke

    Time frame: 12-month

    a neurological deficit with acute onset that persists for at least 24 hours caused by a disturbance of the cerebral circulation due to ischemia or hemorrhage

  17. Stroke

    Time frame: 60-month

    a neurological deficit with acute onset that persists for at least 24 hours caused by a disturbance of the cerebral circulation due to ischemia or hemorrhage

  18. MACE (Major Adverse Cardiac Events)

    Time frame: 12-month

    Composite event of cardiac death, myocardial infarction and clinically-indicated target vesion revascularization

  19. MACE (Major Adverse Cardiac Events)

    Time frame: 60-month

    Composite event of cardiac death, myocardial infarction and clinically-indicated target vesion revascularization

  20. Definite stent thrombosis

    Time frame: 12-month

  21. Definite stent thrombosis

    Time frame: 60-month

  22. Target lesion failure

    Time frame: 12-month

    Composite event of cardiac death, myocardial infarction (MI) of target vessels, and Clinically-indicated TLR

  23. Target lesion failure

    Time frame: 60-month

    Composite event of cardiac death, myocardial infarction (MI) of target vessels, and Clinically-indicated TLR

  24. Target vessel failure

    Time frame: 12-month

  25. Target vessel failure

    Time frame: 60-month

  26. Target lesion revasucularization

    Time frame: 12-month

    PCI performed in the target lesion (within 5 mm of the stent edges), or CABG performed for restenosis of the target lesion or for treatment of other complications

  27. Target lesion revasucularization

    Time frame: 60-month

    PCI performed in the target lesion (within 5 mm of the stent edges), or CABG performed for restenosis of the target lesion or for treatment of other complications

  28. Clinically-driven target lesion revascularization

    Time frame: 12-month

    the revascularization that meets the following criteria; (1) recurrence of angina pectoris, presumably related to the target vessel, (2) objective signs of ischemia at rest or during exercise test (or equivalent), presumably related to the target vessel, (3) Signs of functional ischemia revealed by any invasive diagnostic test (e.g., Doppler flow velocity reserve [FVR], fractional flow reserve [FFR]), and (4) revascularization for ≥ 70% diameter stenosis even in the absence of the above-mentioned ischemic signs or symptoms. Presence/absence of clinical findings is judged by the operator of the procedure before the revascularization.

  29. Clinically-driven target lesion revascularization

    Time frame: 60-month

    the revascularization that meets the following criteria; (1) recurrence of angina pectoris, presumably related to the target vessel, (2) objective signs of ischemia at rest or during exercise test (or equivalent), presumably related to the target vessel, (3) Signs of functional ischemia revealed by any invasive diagnostic test (e.g., Doppler flow velocity reserve [FVR], fractional flow reserve [FFR]), and (4) revascularization for ≥ 70% diameter stenosis even in the absence of the above-mentioned ischemic signs or symptoms. Presence/absence of clinical findings is judged by the operator of the procedure before the revascularization.

  30. Non target lesion revascularization

    Time frame: 12-month

  31. Non target lesion revascularization

    Time frame: 60-month

  32. Coronary artery bypass graft

    Time frame: 12-month

  33. Coronary artery bypass graft

    Time frame: 60-month

  34. Target vessel revascularization

    Time frame: 12-month

  35. Target vessel revascularization

    Time frame: 60-month

  36. Any coronary reascluarization

    Time frame: 12-month

  37. Any coronary reascluarization

    Time frame: 60-month

  38. Bleeding complications

    Time frame: 12-month

    Evaluated with TIMI (major/minor/minimal), GUSTO (severe/moderate) and BARC (Type 1, 2, 3a, 3b, 3c, 4, 5a, 5b)

  39. Bleeding complications

    Time frame: 60-month

    Evaluated with TIMI (major/minor/minimal), GUSTO (severe/moderate) and BARC (Type 1, 2, 3a, 3b, 3c, 4, 5a, 5b)

  40. Gastrointestinal bleeding

    Time frame: 12-month

    Bleeding events requiring upper gastrointestinal endoscopic study or treatment.

  41. Gastrointestinal bleeding

    Time frame: 60-month

    Bleeding events requiring upper gastrointestinal endoscopic study or treatment.

  42. Gastrointestinal complaints

    Time frame: 12-month

    Symptoms requiring upper gastrointestinal endoscopic study or treatment

  43. Gastrointestinal complaints

    Time frame: 60-month

    Symptoms requiring upper gastrointestinal endoscopic study or treatment

  44. Newly diagnosed cancer

    Time frame: 60-month

    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.

Sponsors and collaborators

Lead sponsor

Kyoto University, Graduate School of Medicine

Other

Registry information

Acronym: STOPDAPT-2

Important dates

Study start
2015
Primary completion
2018
Study completion
2023
First posted
Dec 2, 2015
Registry last updated
Jun 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.