Clinical trial NCT03873012: 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 Versus Biolimus A9-eluting Stents
Official title: 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 Versus Biolimus A9-eluting Stents: Retrospective and Prospective Follow-up Study for Patients Who Were Enrolled in the Previous DETECT-OCT Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Coronary Artery Disease
Keywords: Dual antiplatelet therapy duration
Optical coherence tomography
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2019-03-13
Enrollment: 894
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants who already enrolled in DETECT-OCT

Brief summary: This study is a retrospective and prospective follow-up study of patients who were participating in a randomized comparative study (DETECT-OCT trial) to determine the duration of dual antiplatelet therapy for neointimal hyperplasia after Biolimus stent and Everolimus stent insertion . The primary objective of this study was to determine the duration of double antiplatelet therapy (DAPT) based on OCT results at 3 months after percutaneous coronary intervention with OCT guide and percutaneous coronary intervention with guided angiography. After that, patients who were enrolled in the previous DETECT-OCT study will be followed up for a 10 years follow-up.

Detailed description: This clinical trial will be followed for a long time until the 5th and 10th years of patients who have been registered for the DETECT-OCT study To assess the patient's status at 5- and 10-year, follow-up visits are scheduled at the outpatient visit if they are currently followed-up at the registry. However, if there is no follow-up observation at the current registrar, we will follow-up the telephone survey and visit as much as possible. Patients who have already passed the 5-year follow-up period from January 2, 2013, the first time to register, will be followed up by medical records to confirm the progress. To track the progress to the 10-year follow-up, we will conduct prospective observations by telephone survey.

Eligibility criteria: Inclusion Criteria:

* 1. patients who were enrolled in the previous DETECT-OCT study
* 2. Patients who agreed with informed consents

Exclusion Criteria:

* 1. Patients who disagreed with informed consents

Primary outcomes:
measure: Overall survival
timeFrame: At 5 years
measure: Overall survival
timeFrame: At 10 years
measure: Cardiac death
timeFrame: At 5 years
measure: Cardiac death
timeFrame: At 10 years
measure: Myocardial infarction
timeFrame: At 5 years
measure: Myocardial infarction
timeFrame: At 10 years
measure: Target lesion revascularization
timeFrame: At 5 years
measure: Target lesion revascularization
timeFrame: At 10 years
measure: Target vessel revascularization
timeFrame: At 5 years
measure: Target vessel revascularization
timeFrame: At 10 years
measure: Stent thrombosis
timeFrame: At 5 years
measure: Stent thrombosis
timeFrame: At 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Division of Cardiology, Department of Internal Medicine, Yonsei University College of Medicine
Study officials:
References:
citation: Lee SY, Ahn CM, Yoon HJ, Hur SH, Kim JS, Kim BK, Ko YG, Choi D, Jang Y, Hong MK. Early Follow-Up Optical Coherence Tomographic Findings of Significant Drug-Eluting Stent Malapposition. Circ Cardiovasc Interv. 2018 Dec;11(12):e007192. doi: 10.1161/CIRCINTERVENTIONS.118.007192.