Patients, complicated with peripheral arterial occlusive disease, without in-stent stenosis eight months after drug-eluting stent implantation in the left anterior descending coronary
Conditions
Interventions
Group A: administration of cilostazol (200 mg per day) and aspirin (100mg per day) for eight months
Group B: administration of clopidogrel (75 mg per day) and aspirin (100mg per day) for eight months
Sponsors
The Institute of Health Biosciences, The University of Tokushima Graduate School
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects who meet all of the following criteria: 1. Stable angina patients with chronic arterial occlusive disease between the ages of 20 and 80 years old 2. Asymptomatic patients who underwent drug-eluting stent implantation in left anterior descending coronary and had in-stent stenosis rate of less than 50% in contrast study after eight months 3. Patients with heart rate is less than 80 beats per minute 4. Patients follow-up can be more than eight months 5. Patients who receive an explanation of the study, the consent of the study participants was obtained in writing from the person or agent
Exclusion criteria
Exclusion criteria: Subjects who fall under any of the following criteria will be excluded from this study 1. Patients with bleeding or bleeding tendency 2. Patients treated with antiplatelet drugs is not appropriate 3. Patients with a history of hypersensitivity or side effects caused by the study drugs 4. Patients with malapposition on OCT image 5. Patients without visible coating on stent surface on OCT image 6. Patients otherwise judged by the investigator to be inappropriate for inclusion in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. At the start of the study and eight months later, evaluation of either presence or absence of in-stent stenosis in left anterior descending coronary, judging whether new stenotic lesion exists in the left anterior descending coronary by angiography, and determination of stenosis rate by QCA 2. At the start of the study and eight months later, evaluation of vascular reactivity within 20 mm from distal end of in-stent in left anterior descending coronary by load test using acetylcholine and determination of average vessel diameter by QCA 3. At the start of the study and eight months later, evaluation of degree of in-stent intimal thickening (neo-intimal volume %) in left anterior descending coronary by OCT | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. At the start of the study and eight months later, judging whether new stenotic lesion exists in left circumflex coronary by angiography and determination of stenosis rate by QCA 2. At the start of the study and eight months later, evaluation of vascular reactivity within 20 mm from bifurcation of left circumflex coronary artery, or within 20 mm from distal end of in-stent in left anterior descending coronary in case of stent implanted in the range of evaluation, by load test using acetylcholine, and determination of average vessel diameter by QCA | — |
Countries
Japan
Contacts
Public ContactTetsuzo Wakatsuki
Tokushima University Hospital Cardiovascular Medicine
Outcome results
None listed