Status:
COMPLETED
A New Strategy Regarding Discontinuation of Dual Antiplatelet
Lead Sponsor:
Yonsei University
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
20-85 years
Phase:
PHASE4
Brief Summary
Drug-eluting stents (DES), markedly reducing the neointimal hyperplasia after stent implantation compared with bare-metal stents (BMS), have improved angiographic and clinical outcomes in the complex ...
Eligibility Criteria
Inclusion
- Coronary artery disease including stable angina, unstable angina, acute non-ST elevation myocardial infarction and acute ST elevation myocardial infarction
- Age 20 years of older
- Patients with typical chest pain or evidences of myocardial ischemia (e.g., stable, unstable angina, silent ischemia and positive functional study or reversible changes in the electrocardiogram (ECG) consistent with ischemia
- Patients with signed informed consent
- Lesion and stent length for ACS and DM subgroup : Length of single lesion \< 24 mm and, Summation of total length of all inserted DES in 3 vessel \< 60 mm
- Lesion and stent length for ACS and DM subgroup : Length of single lesion \< 24 mm and, Summation of total length of all inserted DES in 3 vessel \< 60 mm
- Lesion and stent length for long lesion subgroup : Length of single stent per single lesion \> 28 mm and, Summation of total length of all inserted DES in 3 vessel ≤ 90 mm, Possible overlapping stent
- Lesion and stent length for short lesion subgroup : Length of single lesion \< 24 mm and, Summation of total length of all inserted DES in 3 vessel \< 60 mm
- Significant coronary artery stenosis (\>50% by visual estimate) considered for coronary revascularization with stent implantation
- Reference vessel diameter of 2.5 to 4.0 mm by operator assessment
- Lesion success (30% or less residual stenosis by visual assessment over the entire stent length, with TIMI-3 flow and no more than an NHLBI type B peri-stent dissection
Exclusion
- Contraindication to anti-platelet agents \& bleeding history within prior 3 months
- Known hypersensitivity or contraindication to any of the following medications: Heparin, Aspirin, Clopidogrel, limus related drug
- Prior history of the following presentations : Cerebral vascular accident (not including transient ischemic attack, Peripheral artery occlusive diseases, Thromboembolic disease, Stent thrombosis
- Severe hepatic dysfunction (3 times normal reference values)
- Significant renal dysfunction (Serum creatinine \> 2.0 mg/dl)
- Significant leukopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis
- Cardiogenic shock
- LVEF \< 40%
- Pregnant women or women with potential childbearing
- Life expectancy 3 year
- Overlapped DESs(only long lesion subgroup is possible overlapping)
- Left main disease requiring PCI
- Bifurcation lesion with 2-stent technique
- Target lesions with in-stent restenosis at the stented segment of DES or BMS
- Lesions with chronic total occlusion
- History of PCI with DES
- In-stent restenosis lesion
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
982 Patients enrolled
Trial Details
Trial ID
NCT01145079
Start Date
May 1 2009
End Date
January 1 2012
Last Update
March 6 2013
Active Locations (1)
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1
Severance Cardiovascular Hospital, Yonsei University College of Medicine
Seoul, South Korea, 120-752