Evaluation of Efficacy and Safety in the 3-Months DAPT Group vs.The 6-Months DAPT Group of Patients Treated with the Coroflex ISAR Stent

Not Applicable

Completed

• Conditions: Symptoms, signs and abnormal clinical and laboratory findings, NEC

• Registration Number: KCT0003736
• Lead Sponsor: Ajou University Hospital

Brief Summary

Between May 2015 and August 2020, 488 patients who underwent Coroflex ISAR stent implantation were enrolled in the study and randomly assigned to the 3-month (n=244) or 6-month (n=244) DAPT group. Compared with 6 months of DAPT, 3 months of DAPT did not increase the risk of primary endpoint 1 year after Coroflex ISAR stent implantation, although it should be noted that the trial has limited power to see differences due to low event rate and low recruitment rate.

Detailed Description

Not available

Study Timeline

• Study Completion: 2020-07-22
• Results First Posted: 2022-07-22
• Last Update Posted: 10 January 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 488

Inclusion Criteria

1.Patients aged 19 or older
2.Patients who have submitted a written consent to participate in the clinical trial.
3.De novo lesion
4.Patients scheduled for elective intervention procedure by Coroflex ISAR Stent to treat ischemic cardiovascular disease

Exclusion Criteria

1. Patients with any contraindications or hypersensitivity related to antiplatelet therapy
2. Patients with Acute Myocardial Infarction (ST segment elevation myocardial infarction,
Non ST segment elevation myocardial infarction)
3. Patients who are anticipated to receive treatment or surgery that may require desisting the administration of
antiplatelet therapy for 2 weeks or longer during the period of the clinical trial
4. Chronic total occlusion (CTO) lesions, in-stent restenosis (ISR)
5. Patients experiencing cardiogenic shock
6. Women who are breastfeeding, pregnant, or desiring pregnancy
7. Patients with findings of hemorrhage
8. Patients with a life expectancy of less than 1 year
9. Patients who have received a drug-eluting stent (DES) procedure within the past 6 months
10. Any other patients judged by the investigator to be unsuitable for the trial

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Major Adverse Cardiac Events (MACE) (cardiac death, recurrent myocardial infarction, target lesion revascularization)

Secondary Outcome Measures

Name	Time	Method
Major Adverse Cardiac Events (MACE) (cardiac death, recurrent myocardial infarction, target lesion revascularization);cardiac death, recurrent myocardial infarction, target lesion revascularization,target vessel revascularization;cardiac death, recurrent myocardial infarction, target lesion revascularization,target vessel revascularization