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ShorT and OPtimal Duration of Dual AntiPlatelet Therapy-2 Study (STOPDAPT-2)

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ClinicalTrials.gov Identifier: NCT02619760
Recruitment Status : Active, not recruiting
First Posted : December 2, 2015
Last Update Posted : March 1, 2019
Sponsor:
Information provided by (Responsible Party):
Takeshi Morimoto, Kyoto University, Graduate School of Medicine

Tracking Information
First Submitted Date  ICMJE November 29, 2015
First Posted Date  ICMJE December 2, 2015
Last Update Posted Date March 1, 2019
Actual Study Start Date  ICMJE December 2015
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 29, 2015)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02619760 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 9, 2015)
  • Composite event of cardiovascular death/myocardial infarction/definite stent thrombosis/stroke [ Time Frame: 12-month ]
  • Composite event of cardiovascular death/myocardial infarction/definite stent thrombosis/stroke [ Time Frame: 60-month ]
  • Bleeding defined as major or minor under the definition of Thrombolysis in Myocardial Infarction (TIMI) Study group [ Time Frame: 12-month ]
  • Bleeding defined as major or minor under the definition of Thrombolysis in Myocardial Infarction (TIMI) Study group [ Time Frame: 60-month ]
  • Upper gastrointestinal endoscopic examination or treatment [ Time Frame: 60-month ]
  • Composite event of all-cause death/myocardial infarction [ Time Frame: 12-month ]
  • Composite event of all-cause death/myocardial infarction [ Time Frame: 60-month ]
  • All-cause death [ Time Frame: 12-month ]
  • All-cause death [ Time Frame: 60-month ]
  • Composite event of cardiovascular death/myocardial infarction [ Time Frame: 12-month ]
  • Composite event of cardiovascular death/myocardial infarction [ Time Frame: 60-month ]
  • Cardiovascular death [ Time Frame: 12-month ]
  • Cardiovascular death [ Time Frame: 60-month ]
  • Myocardial infarction [ Time Frame: 12-month ]
  • Myocardial infarction [ Time Frame: 60-month ]
  • 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
  • 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
  • MACE (Major Adverse Cardiac Events) [ Time Frame: 12-month ]
    Composite event of cardiac death, myocardial infarction and clinically-indicated target vesion revascularization
  • MACE (Major Adverse Cardiac Events) [ Time Frame: 60-month ]
    Composite event of cardiac death, myocardial infarction and clinically-indicated target vesion revascularization
  • Definite stent thrombosis [ Time Frame: 12-month ]
  • Definite stent thrombosis [ Time Frame: 60-month ]
  • Target lesion failure [ Time Frame: 12-month ]
    Composite event of cardiac death, myocardial infarction (MI) of target vessels, and Clinically-indicated TLR
  • Target lesion failure [ Time Frame: 60-month ]
    Composite event of cardiac death, myocardial infarction (MI) of target vessels, and Clinically-indicated TLR
  • Target vessel failure [ Time Frame: 12-month ]
  • Target vessel failure [ Time Frame: 60-month ]
  • 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
  • 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
  • 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.
  • 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.
  • Non target lesion revascularization [ Time Frame: 12-month ]
  • Non target lesion revascularization [ Time Frame: 60-month ]
  • Coronary artery bypass graft [ Time Frame: 12-month ]
  • Coronary artery bypass graft [ Time Frame: 60-month ]
  • Target vessel revascularization [ Time Frame: 12-month ]
  • Target vessel revascularization [ Time Frame: 60-month ]
  • Any coronary reascluarization [ Time Frame: 12-month ]
  • Any coronary reascluarization [ Time Frame: 60-month ]
  • 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)
  • 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)
  • Gastrointestinal bleeding [ Time Frame: 12-month ]
    Bleeding events requiring upper gastrointestinal endoscopic study or treatment.
  • Gastrointestinal bleeding [ Time Frame: 60-month ]
    Bleeding events requiring upper gastrointestinal endoscopic study or treatment.
  • Gastrointestinal complaints [ Time Frame: 12-month ]
    Symptoms requiring upper gastrointestinal endoscopic study or treatment
  • Gastrointestinal complaints [ Time Frame: 60-month ]
    Symptoms requiring upper gastrointestinal endoscopic study or treatment
Original Secondary Outcome Measures  ICMJE
 (submitted: November 29, 2015)
  • Composite event of cardiovascular death/myocardial infarction/definite stent thrombosis/stroke [ Time Frame: 12-month ]
  • Composite event of cardiovascular death/myocardial infarction/definite stent thrombosis/stroke [ Time Frame: 60-month ]
  • Bleeding defined as major or minor under the definition of Thrombolysis in Myocardial Infarction (TIMI) Study group [ Time Frame: 12-month ]
  • Bleeding defined as major or minor under the definition of Thrombolysis in Myocardial Infarction (TIMI) Study group [ Time Frame: 60-month ]
  • Upper gastrointestinal endoscopic examination or treatment [ Time Frame: 60-month ]
  • Composite event of all-cause death/myocardial infarction [ Time Frame: 12-month ]
  • Composite event of all-cause death/myocardial infarction [ Time Frame: 60-month ]
  • All-cause death [ Time Frame: 12-month ]
  • All-cause death [ Time Frame: 60-month ]
  • Composite event of cardiovascular death/myocardial infarction [ Time Frame: 12-month ]
  • Composite event of cardiovascular death/myocardial infarction [ Time Frame: 60-month ]
  • Cardiovascular death [ Time Frame: 12-month ]
  • Cardiovascular death [ Time Frame: 60-month ]
  • Myocardial infarction [ Time Frame: 12-month ]
  • Myocardial infarction [ Time Frame: 60-month ]
  • Stroke [ Time Frame: 12-month ]
  • Stroke [ Time Frame: 60-month ]
  • Definite stent thrombosis [ Time Frame: 12-month ]
  • Definite stent thrombosis [ Time Frame: 60-month ]
  • Target lesion failure [ Time Frame: 12-month ]
  • Target lesion failure [ Time Frame: 60-month ]
  • Target vessel failure [ Time Frame: 12-month ]
  • Target vessel failure [ Time Frame: 60-month ]
  • Target lesion revasucularization [ Time Frame: 12-month ]
  • Target lesion revasucularization [ Time Frame: 60-month ]
  • Clinically-driven target lesion revascularization [ Time Frame: 12-month ]
  • Clinically-driven target lesion revascularization [ Time Frame: 60-month ]
  • Non target lesion revascularization [ Time Frame: 12-month ]
  • Non target lesion revascularization [ Time Frame: 60-month ]
  • Coronary artery bypass graft [ Time Frame: 12-month ]
  • Coronary artery bypass graft [ Time Frame: 60-month ]
  • Target vessel revasrularization [ Time Frame: 12-month ]
  • Target vessel revasrularization [ Time Frame: 60-month ]
  • Any coronary reascluarization [ Time Frame: 12-month ]
  • Any coronary reascluarization [ Time Frame: 60-month ]
  • Bleeding complications [ Time Frame: 12-month ]
  • Bleeding complications [ Time Frame: 60-month ]
  • Gastrointestinal bleeding [ Time Frame: 12-month ]
  • Gastrointestinal bleeding [ Time Frame: 60-month ]
  • Gastrointestinal complaints [ Time Frame: 12-month ]
  • Gastrointestinal complaints [ Time Frame: 60-month ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ShorT and OPtimal Duration of Dual AntiPlatelet Therapy-2 Study
Official Title  ICMJE ShorT and OPtimal Duration of Dual AntiPlatelet Therapy-2 Study
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).
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. 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. We therefore planned a multicenter, randomized, open-label, controlled study, in which the subjects who have undergone CoCr-EES procedure will be diveded 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-inferiorty 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Coronary Artery Disease
Intervention  ICMJE
  • Drug: 1-month DAPT
    1-month dual antiplatelet therapy (DAPT) composed of aspirin and P2Y12 receptor antagonists
  • Drug: 12-month DAPT
    12-month dual antiplatelet therapy (DAPT) composed of aspirin and P2Y12 receptor antagonists
Study Arms  ICMJE
  • Active Comparator: 1-month DAPT
    1-month dual antiplatelet therapy (DAPT) composed of aspirin and P2Y12 receptor antagonists , followed by 59-month clopidogrel monotherapy
    Intervention: Drug: 1-month DAPT
  • Active Comparator: 12-month DAPT
    1-month dual antiplatelet therapy (DAPT) composed of aspirin and P2Y12 receptor antagonists with 11-month DAPT composed of aspirin and clopidogrel, followed by 48-month aspirin monotherapy
    Intervention: Drug: 12-month DAPT
Publications * Watanabe H, Domei T, Morimoto T, Natsuaki M, Shiomi H, Toyota T, Ohya M, Suwa S, Takagi K, Nanasato M, Hata Y, Yagi M, Suematsu N, Yokomatsu T, Takamisawa I, Doi M, Noda T, Okayama H, Seino Y, Tada T, Sakamoto H, Hibi K, Abe M, Kawai K, Nakao K, Ando K, Tanabe K, Ikari Y, Hanaoka KI, Morino Y, Kozuma K, Kadota K, Furukawa Y, Nakagawa Y, Kimura T; STOPDAPT-2 Investigators. Effect of 1-Month Dual Antiplatelet Therapy Followed by Clopidogrel vs 12-Month Dual Antiplatelet Therapy on Cardiovascular and Bleeding Events in Patients Receiving PCI: The STOPDAPT-2 Randomized Clinical Trial. JAMA. 2019 Jun 25;321(24):2414-2427. doi: 10.1001/jama.2019.8145.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: December 12, 2017)
3045
Original Estimated Enrollment  ICMJE
 (submitted: November 29, 2015)
3000
Estimated Study Completion Date  ICMJE December 2023
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02619760
Other Study ID Numbers  ICMJE C1114
UMIN000019948 ( Other Identifier: UMIN )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Takeshi Morimoto, Kyoto University, Graduate School of Medicine
Study Sponsor  ICMJE Kyoto University, Graduate School of Medicine
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Takeshi Kimura, MD, PhD Professor of Medicine, Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine
PRS Account Kyoto University, Graduate School of Medicine
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP