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)

Ajou University School of Medicine

Status and phase: Unknown; Phase 4

Conditions: Stable Angina, Unstable Angina, Silent Coronary Ischemia, Coronary Artery Disease

Treatments: Device: Coroflex ISAR; Drug: 3 months DAPT; Drug: 6 months DAPT

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02609698

AJOU-CV-0001

Details and patient eligibility

About

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.

Enrollment: 906 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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906 participants in 2 patient groups

Coroflex ISAR 3 months DAPT

Experimental group

Description:

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

Treatment:

Drug: 3 months DAPT

Device: Coroflex ISAR

Coroflex ISAR 6 months DAPT

Active Comparator group

Description:

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

Treatment:

Drug: 6 months DAPT

Device: Coroflex ISAR