DETErmination of the Duration of the Dual Antiplatelet Therapy by the Degree of the Coverage of The Struts on Optical Coherence Tomography From the Randomized Comparison Between Everolimus-eluting Stents(EES) Versus Biolimus A9-eluting Stents(BES) (DETECT-OCT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2015 by Yonsei University
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01752894
First received: December 14, 2012
Last updated: February 26, 2015
Last verified: February 2015
  Purpose

The purpose of the study is 1> to compare neointimal stent coverage after OCT-guided vs. Angio-guided PCI, 2> to compare neointimal stent coverage at 3 months after EES vs BES implantation, 3> to determine the duration of dual antiplatelet therapy by OCT measurement at 3 months


Condition Intervention
Ischemic Heart Disease
Device: Angio-guided PCI with EES or BES
Device: OCT-guided PCI with EES or BES
Device: PCI with BES under angio-guide or OCT guide
Device: PCI with EES under angio-guide or OCT guide
Drug: Keep DAPT
Drug: Discontinue DAPT

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • percentage of neointimal coverage at 3 month-OCT after stent implantation [ Time Frame: at 3 month-OCT after stent implantation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The occurrence of the composite of cardiac death, MI, definite or probable stent thrombosis, and TIMI-defined major bleeding for 12 motnhs [ Time Frame: 12 months after PCI ] [ Designated as safety issue: Yes ]
  • percentage of malapposition strut at 3 month-OCT after stent implantation [ Time Frame: 3 months after PCI ] [ Designated as safety issue: No ]
  • The occurrence of the composite of All cause death, spontaneous MI, Target vessel revascularization and stroke. [ Time Frame: 12 months after PCI ] [ Designated as safety issue: Yes ]
  • Target vessel revascularization [ Time Frame: 12 months after PCI ] [ Designated as safety issue: No ]
  • TIMI-defined major bleeding for 12 motnhs [ Time Frame: 12 months after PCI ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1100
Study Start Date: January 2013
Estimated Study Completion Date: November 2017
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Angio guided PCI Device: Angio-guided PCI with EES or BES
Angio-guided intervention
Experimental: OCT-guided PCI Device: OCT-guided PCI with EES or BES
OCT-guided intervention
Active Comparator: BES Device: PCI with BES under angio-guide or OCT guide
biolimus A9-eluting stent.
Experimental: EES Device: PCI with EES under angio-guide or OCT guide
everolimus eluting stent.
Active Comparator: Keep dual antiplatelet therapy (DAPT)
Study subjects will be allocated into this arm with non-randomization method
Drug: Keep DAPT
maintain DAPT for 12 months according to level of uncovered strut (>6%) at 3months OCT follow up after stent implantation.
Active Comparator: Discontinue Dual antiplatelet therapy (DAPT)
Study subjects will be allocated into this arm with non-randomization method
Drug: Discontinue DAPT
discontinue DAPT according to level of uncovered strut (≤6%) at 3months OCT follow up after stent implantation.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients ≥ 20 years old
  • Patients with ischemic heart disease who are considered for coronary revascularization with stent implantation.
  • Significant coronary de novo lesion (stenosis > 70% by quantitative angiographic analysis) treated by single DES ≤ 25mm
  • Reference vessel diameter of 2.5 to 3.5 mm by operator assessment

Exclusion Criteria:

  • Complex lesion morphologies such as arota-ostial, unprotected left main, chronic total occlusion, graft, thrombosis, and restenosis
  • Reference vessel diameter < 2.5 mm or > 4.0mm
  • Heavy calcified lesions (definite calcified lesions on angiogram)
  • Primary PCI for STEMI
  • Contraindication to anti-platelet agents
  • Treated with any DES within 3 months at other vessel
  • Creatinine level ≥ 2.0 mg/dL or ESRD
  • Severe hepatic dysfunction (3 times normal reference values)
  • Pregnant women or women with potential childbearing
  • Life expectancy < 1 year
  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: NCT01752894

Contacts
Contact: MYEONG-KI HONG, MD 82-2-2228-8458 MKHONG61@yuhs.ac

Locations
Korea, Republic of
Division of Cardiology, Department of Internal Medicine, Yonsei University College of Medicine Recruiting
Seoul, Korea, Republic of, 120-752
Contact: MYEONG-KI HONG, MD    82-2-2228-8458    MKHONG61@yuhs.ac   
Sponsors and Collaborators
Yonsei University
  More Information

No publications provided

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01752894     History of Changes
Other Study ID Numbers: 1-2012-0047
Study First Received: December 14, 2012
Last Updated: February 26, 2015
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

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

ClinicalTrials.gov processed this record on July 30, 2015