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)

Study Overview
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Brief Summary
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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.

Official Title
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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

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

Intervention / Treatment
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* Device: Coroflex ISAR
* Drug: 3 months DAPT
* Drug: 6 months DAPT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 19 or older Patients who have submitted a written consent to participate in the clinical trial De novo lesion Patients scheduled for elective intervention to treat ischemic cardiovascular disease Exclusion Criteria: Patients with any contraindications or hypersensitivity related to antiplatelet therapy Patients with Acute Myocardial Infarction (ST elevation myocardial infarction, Non ST elevation myocardial infarction) 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 Chronic total occlusion (CTO) lesions, in-stent restenosis (ISR) Patients experiencing cardiogenic shock Women who are breastfeeding, pregnant, or desiring pregnancy Patients with findings of hemorrhage Patients with a life expectancy of less than 1 year Patients who have received a drug-eluting stent (DES) procedure within the past 6 months Any other patients judged by the investigator to be unsuitable for the trial
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Coroflex ISAR 3 months DAPT<br>Patients who have received a Coroflex ISAR stent procedure to treat coronary arterial lesions, and administered the drug for 3 months | Device: Coroflex ISAR<br>* This stent platform has a thin-strut cobalt-chromiun alloy backbone, no polymer, microporous surface.<br>Drug: 3 months DAPT<br> <br> * Other names: Aspirin + clopidogrel for 3-months schedule after the coronary stenting;|
| Active Comparator: Coroflex ISAR 6 months DAPT<br>Patients who have received a Coroflex ISAR stent procedure to treat coronary arterial lesions, and administered the drug for 6 months | Device: Coroflex ISAR<br>* This stent platform has a thin-strut cobalt-chromiun alloy backbone, no polymer, microporous surface.<br>Drug: 6 months DAPT<br> <br> * Other names: Aspirin + clopidogrel for 6-months schedule after the coronary stenting;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MACE |  | 6 months from the time of the stenting | 
| Any death, cardiac death, MI, TLR, TVR |  | 6 months from the time of the stenting | 
| Any death, cardiac death, MI, Stroke, TLR, TVR |  | 12 months from the time of the stenting | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DES, Stent, Polymer-free, Antiplatelet therapy, Clopidogrel, DAPT