Short and Optimal Duration of Dual Antiplatelet Therapy Study
STOPDAPT
1 other identifier
interventional
1,525
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 coronary-artery-disease
Started Sep 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 30, 2012
CompletedFirst Posted
Study publicly available on registry
August 7, 2012
CompletedStudy Start
First participant enrolled
September 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedDecember 10, 2015
December 1, 2015
2.1 years
July 30, 2012
December 9, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Major cardiovascular and bleeding events
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).
1-year
Secondary Outcomes (18)
Cardiovascular death/MI/stroke/definite ST
1-year
Major bleeding (TIMI Major/Minor)
1-year
Death/MI
1-year
All-cause death
1-year
Cardiovascular death/MI
1-year
- +13 more secondary outcomes
Study Arms (1)
Thienopyridine
EXPERIMENTALThienopyridine treatment for 3 months after implantation of everolimus-eluting Stents
Interventions
Eligibility Criteria
You may qualify if:
- Patients who received PCI using everolimus-eluting cobalt-chromium stents
You may not qualify if:
- Patients who had been implanted drug-eluting stents other than everolimus-eluting cobalt-chromium stents
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takeshi Morimotolead
Study Sites (1)
Department of Cardiovascular Medicine, Kyoto University Hospital
Kyoto, Kyoto, 606-8507, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Takeshi Kimura, MD, PhD
Professor of Medicine, Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor of Medicine
Study Record Dates
First Submitted
July 30, 2012
First Posted
August 7, 2012
Study Start
September 1, 2012
Primary Completion
October 1, 2014
Study Completion
December 1, 2014
Last Updated
December 10, 2015
Record last verified: 2015-12