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)

• Status: Unknown status
• Trial end date: 2019-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ajou University School of Medicine
• Collaborator: B. Braun Korea Co., Ltd.
• Treatments: Aspirin; Clopidogrel; Ticlopidine

Criteria

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