Stable Angina, Unstable Angina, Silent Coronary Ischemia, Coronary Artery Disease Clinical Trial
Official title:
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
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.
| Status | Recruiting |
| Enrollment | 906 |
| Est. completion date | June 2019 |
| Est. primary completion date | December 2018 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Ajou University Hospital | Yeongtong-gu | Suwon |
| Lead Sponsor | Collaborator |
|---|---|
| Ajou University School of Medicine | B. Braun Korea Co., Ltd. |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | MACE | Major Adverse Cardiac Events (MACE) (cardiac death, recurrent myocardial infarction, target lesion revascularization) at 12 months from the time of the procedure | 12 months from the time of the stenting | Yes |
| Secondary | MACE | 6 months from the time of the stenting | Yes | |
| Secondary | Any death, cardiac death, MI, TLR, TVR | 6 months from the time of the stenting | Yes | |
| Secondary | Any death, cardiac death, MI, Stroke, TLR, TVR | 12 months from the time of the stenting | Yes |