ISAR-DAPT (A Comparative 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; A Prospective, Multicenter, Randomized, Open-Label Clinical Trial)

Phase 4

• Conditions: Stable Angina, Unstable Angina, Silent Coronary Ischemia, Coronary Artery Disease
• Interventions: Device: Coroflex ISAR; Drug: 3 months DAPT; Drug: 6 months DAPT

• Registration Number: NCT02609698
• Lead Sponsor: Ajou University School of Medicine

Brief Summary

This clinical trial studies patients treated with the Coroflex ISAR Stent for coronary artery disease in order for the objective of verifying the non-inferiority of results that among patients who were administered DAPT for 3 months compared to patients who were administered DAPT for 6 months, in terms of the efficacy and safety of DAPT.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08
• Status Verified: 2015-11
• Study First Submitted: 2015-11-18
• Study First Submitted QC: 2015-11-18
• Last Update Submitted: 2015-11-18
• Study First Posted: 2015-11-20
• Last Update Posted: 2015-11-20
• Primary Completion: 2018-12
• Study Completion: 2019-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 906

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 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 elevation myocardial infarction, Non ST 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 Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Coroflex ISAR 3 months DAPT	3 months DAPT	Patients who have received a Coroflex ISAR stent procedure to treat coronary arterial lesions, and administered the drug for 3 months
Coroflex ISAR 6 months DAPT	6 months DAPT	Patients who have received a Coroflex ISAR stent procedure to treat coronary arterial lesions, and administered the drug for 6 months
Coroflex ISAR 3 months DAPT	Coroflex ISAR	Patients who have received a Coroflex ISAR stent procedure to treat coronary arterial lesions, and administered the drug for 3 months
Coroflex ISAR 6 months DAPT	Coroflex ISAR	Patients who have received a Coroflex ISAR stent procedure to treat coronary arterial lesions, and administered the drug for 6 months

Primary Outcome Measures

Name	Time	Method
MACE	12 months from the time of the stenting	Major Adverse Cardiac Events (MACE) (cardiac death, recurrent myocardial infarction, target lesion revascularization) at 12 months from the time of the procedure

Secondary Outcome Measures

Name	Time	Method
MACE	6 months from the time of the stenting
Any death, cardiac death, MI, Stroke, TLR, TVR	12 months from the time of the stenting
Any death, cardiac death, MI, TLR, TVR	6 months from the time of the stenting

Trial Locations

Locations (1)

Ajou University Hospital; 🇰🇷 Yeongtong-gu, Suwon, Korea, Republic of