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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by Kyoto University, Graduate School of Medicine
Sponsor:
Information provided by (Responsible Party):
Takeshi Morimoto, Kyoto University, Graduate School of Medicine
ClinicalTrials.gov Identifier:
NCT01659034
First received: July 30, 2012
Last updated: September 11, 2012
Last verified: September 2012
  Purpose

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 Intervention Phase
Coronary Artery Disease
Drug: Thienopyridine for 3 months
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Short and Optimal Duration of Dual Antiplatelet Therapy Study

Further study details as provided by Kyoto University, Graduate School of Medicine:

Primary Outcome Measures:
  • Major cardiovascular and bleeding events [ Time Frame: 1-year ] [ Designated as safety issue: Yes ]
    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:
  • Cardiovascular death/MI/stroke/definite ST [ Time Frame: 1-year ] [ Designated as safety issue: Yes ]
    Composite of cardiovascular death, myocardial infarction, stroke, and definite stent thrombosis

  • Major bleeding (TIMI Major/Minor) [ Time Frame: 1-year ] [ Designated as safety issue: Yes ]
    Major bleeding (TIMI Major/Minor)

  • Death/MI [ Time Frame: 1-year ] [ Designated as safety issue: Yes ]
    Composite of all-cause death and myocardial infarction

  • All-cause death [ Time Frame: 1-year ] [ Designated as safety issue: Yes ]
    All-cause death

  • Cardiovascular death/MI [ Time Frame: 1-year ] [ Designated as safety issue: Yes ]
    Composite of cardiovascular death and myocardial infarction

  • Cardiovascular death [ Time Frame: 1-year ] [ Designated as safety issue: Yes ]
    Cardiovascular death

  • MI [ Time Frame: 1-year ] [ Designated as safety issue: Yes ]
    Myocardial infarction

  • Stroke [ Time Frame: 1-year ] [ Designated as safety issue: Yes ]
    Both ischemic and hemorrhagic stroke excluding transient ischemic attack

  • Stent Thrombosis [ Time Frame: 1-year ] [ Designated as safety issue: Yes ]
    Stent thrombosis according to Academic Research Consortium classification

  • Target Lesion Failure [ Time Frame: 1-year ] [ Designated as safety issue: Yes ]
    Composite of cardiovascular death, myocardial infarction due to target vessel, and target lesion revascularization

  • Target Vessel Failure [ Time Frame: 1-year ] [ Designated as safety issue: Yes ]
    Composite of cardiovascular death, myocardial infarction, and target vessel revascularization

  • Major Adverse Cardiac Events [ Time Frame: 1-year ] [ Designated as safety issue: Yes ]
    Composite of cardiovascular death, myocardial infarction, and clinically-driven target lesion revascularization

  • Target Lesion Revascularization [ Time Frame: 1-year ] [ Designated as safety issue: Yes ]
    Target lesion revascularization

  • Clinically-driven Target Lesion Revascularization [ Time Frame: 1-year ] [ Designated as safety issue: Yes ]
    Clinically-driven Target Lesion Revascularization

  • Non Target Lesion Revascularization [ Time Frame: 1-year ] [ Designated as safety issue: Yes ]
    Revascularization for non-target vessel or target vessel but target lesion

  • CABG [ Time Frame: 1-year ] [ Designated as safety issue: Yes ]
    Coronary artery bypass graft

  • Target Vessel Revascularization [ Time Frame: 1-year ] [ Designated as safety issue: Yes ]
    Target vessel revascularization

  • Any bleeding [ Time Frame: 1-year ] [ Designated as safety issue: Yes ]
    Any bleeding complications


Estimated Enrollment: 1500
Study Start Date: September 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Thienopyridine
Thienopyridine treatment for 3 months after implantation of everolimus-eluting Stents
Drug: Thienopyridine for 3 months

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.

  Eligibility

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01659034

Contacts
Contact: Takeshi Kimura, MD, PhD +81-75-751-4254 taketaka@kuhp.kyoto-u.ac.jp
Contact: Takeshi Morimoto, MD, PhD +81-72-366-0221 morimoto@kuhp.kyoto-u.ac.jp

Locations
Japan
Department of Cardiovascular Medicine, Kyoto University Hospital Recruiting
Kyoto, Japan, 606-8507
Contact: Takeshi Kimura, MD, PhD    +81-75-751-4254    taketaka@kuhp.kyoto-u.ac.jp   
Contact: Masahiro Natsuaki, MD    +81-75-751-4255    natsuaki@kuhp.kyoto-u.ac.jp   
Principal Investigator: Takeshi Kimura, MD, PhD         
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

No publications provided

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
Study First Received: July 30, 2012
Last Updated: September 11, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by 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

ClinicalTrials.gov processed this record on September 18, 2014