Status:
COMPLETED
Additional Benefit of Cilostazol to Dual Antiplatelet Therapy After Biolimus-eluting Stent Implantation
Lead Sponsor:
Yonsei University
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Because there is limited data about long-term efficacy and safety about short-term use of cilostazol adding to dual antiplatelet therapy in patients with long or multivessel coronary artery disease af...
Detailed Description
Previous randomized trials have shown the efficacy of drug-eluting stent (DES) such as sirolimus-eluting stent (CYPHERTM, Cordis, Warren, NJ, USA), paclitaxel-eluting stent (TAXUSTM, BostonScientific,...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Age \> 18 years.
- Subject is able to verbally confirm understandings of risks, benefits and treatment alternatives of receiving the BioMatrix® and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure.
- Subject must have significant coronary artery stenosis (\>70% by visual estimate).
- Subject must have evidence of myocardial ischemia (e.g., stable, unstable angina, recent infarction, acute myocardial infarction, silent ischemia, positive functional study or a reversible changes in the ECG consistent with ischemia).
- Target lesion(s) located in a native coronary artery with visually estimated diameter of ≥ 2.0 and ≤ 4.24 mm
- Target lesion(s) amenable for PCI
- Lesion(s) must have at least 1 of these 2 angiographic features to be eligible
- Lesion(s) need(s) stent length ≥ 28mm (multiple stents whether are overlapped or not are allowed. No limitation of stent length)
- Multivessel coronary artery disease that need ≥2 stents regardless of stent length
- Significant (\>70%) lesions in at least two major epicardial vessels (≥ 2.0mm in diameter)
- Lesion(s) of chronic total occlusion or bifurcation which need ≥ 2 stents can be eligible
- Exclusion criteria:
- The subject has a known hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel, biolimus A9, stainless steel, cobalt chromium, contrast media\*. (\*Subjects with documented sensitivity to contrast media, which can be effectively premedicated with steroid and diphenhydramine may be enrolled. However, those with true anaphylaxis to prior contrast media should not be enrolled.)
- Systemic (intravenous) biolimus A9 use within 12 months.
- Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study.
- History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions.
- Gastrointestinal or genitourinary bleeding within the prior 3 months, or major surgery within 2 months.
- Current known current platelet count \<100,000 cells/mm3 or Hgb \<10 g/dL.
- An elective surgical procedure is planned that would necessitate interruption of thienopyridines during the first 12 months post enrollment
- Non-cardiac co-morbid conditions are present with life expectancy \<1 year or that may result in protocol non-compliance (per site investigator's medical judgment).
- Subjects who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
- Subjects who have received DES implantation in the any coronary artery prior to enrollment
- Subjects with heart failure, NYHA class III or IV or those with cardiogenic shock. (The degree of left ventricular ejection fraction is not considered as an index of exclusion)
- Creatinine level \> 3.0mg/dL or dependence on dialysis.
- Severe hepatic dysfunction AST or ALT \> 3 times upper normal reference values) except MI-induced elevation
- Subjects who need antagonist of vitamin K due during study
- Isolated left main disease (lesion(s) at proximal LAD or LCX lesion that need to cross the left main can be enrolled)
- Target lesion(s) with ISR
Exclusion
Key Trial Info
Start Date :
March 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
630 Patients enrolled
Trial Details
Trial ID
NCT01192724
Start Date
March 1 2010
End Date
December 1 2012
Last Update
November 15 2016
Active Locations (1)
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1
Wonju Christian Hospital
Wŏnju, Gangwon-do, South Korea, 220-050