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Short and Optimal Duration of Dual Antiplatelet Therapy Study (STOPDAPT)

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ClinicalTrials.gov Identifier: NCT01659034
Recruitment Status : Completed
First Posted : August 7, 2012
Last Update Posted : December 10, 2015
Sponsor:
Information provided by (Responsible Party):
Takeshi Morimoto, Kyoto University, Graduate School of Medicine

Study Description
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Brief Summary:
The purpose of this study is to evaluate safety of reduction of thienopyridine treatment period to 3 months after implantation of Cobalt-Chromium everolimus-eluting Stents.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Drug: Thienopyridine for 3 months Phase 4

Detailed Description:

"Thienopyridine antiplatelet agents have markedly inhibited incidence of stent thrombosis, when they were combined with aspirin for 1 month after implantation of bare-metal stent (BMS). On the other hand, combination of aspirin with thienopyridine (dual antiplatelet therapy: DAPT) for more than 1 year after drug-eluting stent (DES) implantation is frequently used to prevent very late stent thrombosis in the current clinical practice. In the RESET study, which was carried out in clinical practice in Japan, DAPT was performed for at least 1 year in 90% of the patients. However, there has been no report showing that long-term thienopyridine treatment for at least 1 year reduces incidence of serious cardiovascular events, and large-scale observational studies or small-scale randomized comparative studies have demonstrated that thienopyridine treatment for 6 months or for at least 12 months does not reduce incidence of serious cardiovascular events. These results suggest that the optimal duration of DAPT after DES implantation may be shorter than 6 months.

With respect to Everolimus-eluting stent (EES), which is the most widely used DES in Japan, it has been associated with significantly lower incidence of early or late stent thrombosis compared with the first-generation DES and with BMS in large-scale observational study and randomized comparative studies and their meta-analyses.

Considering that long-term DAPT obviously increases hemorrhagic complications compared to Aspirin monotherapy, it is desirable to reduce the duration of DAPT as far as possible, if long-term DAPT is not effective in inhibiting the incidence of serious cardiovascular events. Moreover, long-term DAPT enormously increases medical expenses. In this study, we planned an exploratory multicenter study to evaluate incidences of cardiovascular events and bleeding events at 12 months after stent implantation using an EES (XIENCE Prime™), which is associated with low risk of stent thrombosis, when thienopyridine therapy is discontinued at 3 months after surgery.


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1525 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Short and Optimal Duration of Dual Antiplatelet Therapy Study
Study Start Date : September 2012
Actual Primary Completion Date : October 2014
Actual Study Completion Date : December 2014
Arms and Interventions
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Arm Intervention/treatment
Experimental: Thienopyridine
Thienopyridine treatment for 3 months after implantation of everolimus-eluting Stents
 Drug: Thienopyridine for 3 months


Outcome Measures
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Primary Outcome Measures :
  1. Major cardiovascular and bleeding events [ Time Frame: 1-year ]
    Composite of cardiovascular death, myocardial infarction, stroke (ischemic and hemorrhagic), stent thrombosis (definite stent thrombosis not resulting in myocardial infarction), and major bleeding (TIMI Major/Minor) Cardiovascular death, myocardial infarction and stent thrombosis are defined according to the definition in the Academic Research Consortium (ARC). Stroke is defined as ischemic or hemorrhagic stroke with symptoms lasting > 24 hour. Major bleeding is defined according to the definition in the Thrombosis in Myocardial Infarction (TIMI).


Secondary Outcome Measures :
  1. Cardiovascular death/MI/stroke/definite ST [ Time Frame: 1-year ]
    Composite of cardiovascular death, myocardial infarction, stroke, and definite stent thrombosis

  2. Major bleeding (TIMI Major/Minor) [ Time Frame: 1-year ]
    Major bleeding (TIMI Major/Minor)

  3. Death/MI [ Time Frame: 1-year ]
    Composite of all-cause death and myocardial infarction

  4. All-cause death [ Time Frame: 1-year ]
    All-cause death

  5. Cardiovascular death/MI [ Time Frame: 1-year ]
    Composite of cardiovascular death and myocardial infarction

  6. Cardiovascular death [ Time Frame: 1-year ]
    Cardiovascular death

  7. MI [ Time Frame: 1-year ]
    Myocardial infarction

  8. Stroke [ Time Frame: 1-year ]
    Both ischemic and hemorrhagic stroke excluding transient ischemic attack

  9. Stent Thrombosis [ Time Frame: 1-year ]
    Stent thrombosis according to Academic Research Consortium classification

  10. Target Lesion Failure [ Time Frame: 1-year ]
    Composite of cardiovascular death, myocardial infarction due to target vessel, and target lesion revascularization

  11. Target Vessel Failure [ Time Frame: 1-year ]
    Composite of cardiovascular death, myocardial infarction, and target vessel revascularization

  12. Major Adverse Cardiac Events [ Time Frame: 1-year ]
    Composite of cardiovascular death, myocardial infarction, and clinically-driven target lesion revascularization

  13. Target Lesion Revascularization [ Time Frame: 1-year ]
    Target lesion revascularization

  14. Clinically-driven Target Lesion Revascularization [ Time Frame: 1-year ]
    Clinically-driven Target Lesion Revascularization

  15. Non Target Lesion Revascularization [ Time Frame: 1-year ]
    Revascularization for non-target vessel or target vessel but target lesion

  16. CABG [ Time Frame: 1-year ]
    Coronary artery bypass graft

  17. Target Vessel Revascularization [ Time Frame: 1-year ]
    Target vessel revascularization

  18. Any bleeding [ Time Frame: 1-year ]
    Any bleeding complications


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who received PCI using everolimus-eluting cobalt-chromium stents

Exclusion Criteria:

  • Patients who had been implanted drug-eluting stents other than everolimus-eluting cobalt-chromium stents
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01659034


Locations
Japan
Department of Cardiovascular Medicine, Kyoto University Hospital
Kyoto, Japan, 606-8507
Sponsors and Collaborators
Takeshi Morimoto
Investigators
Principal Investigator: Takeshi Kimura, MD, PhD Professor of Medicine, Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine
More Information
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Responsible Party: Takeshi Morimoto, Professor of Medicine, Kyoto University, Graduate School of Medicine
ClinicalTrials.gov Identifier: NCT01659034     History of Changes
Other Study ID Numbers: C-645
First Posted: August 7, 2012    Key Record Dates
Last Update Posted: December 10, 2015
Last Verified: December 2015

Keywords provided by Takeshi Morimoto, Kyoto University, Graduate School of Medicine:
Anti-platelet therapy

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases