We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
Verified February 2015 by Yonsei University
Sponsor:
ClinicalTrials.gov Identifier:
NCT01752894
First Posted: December 19, 2012
Last Update Posted: March 2, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Yonsei University
  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
Intervention Model: Parallel Assignment
Masking: None (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 ]

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 ]
  • percentage of malapposition strut at 3 month-OCT after stent implantation [ Time Frame: 3 months after PCI ]
  • The occurrence of the composite of All cause death, spontaneous MI, Target vessel revascularization and stroke. [ Time Frame: 12 months after PCI ]
  • Target vessel revascularization [ Time Frame: 12 months after PCI ]
  • TIMI-defined major bleeding for 12 motnhs [ Time Frame: 12 months after PCI ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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): 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

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01752894     History of Changes
Other Study ID Numbers: 1-2012-0047
First Submitted: December 14, 2012
First Posted: December 19, 2012
Last Update Posted: March 2, 2015
Last Verified: February 2015

Additional relevant MeSH terms:
Heart Diseases
Myocardial Ischemia
Coronary Artery Disease
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases
Everolimus
Umirolimus
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Inflammatory Agents