Clinical trial NCT00708669: Japan-Drug Eluting Stents Evaluation; a Randomized Trial
Official title: A Japanese Prospective, Randomized, Multi-center Trial Comparing the TAXUS Stent and the CYPHER Stent in Patients With Coronary Artery Disease Eligible for PCI.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Lead sponsor: Associations for Establishment of Evidence in Interventions
Sponsor class: OTHER
First posted: 2008-07-02
Enrollment: 3500
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the procedural, short and long term clinical outcomes of the TAXUS stent compared to Cypher stent in coronary arteries of ≥ 2.5 and ≤ 3.75 mm in the reference vessel diameter with a lesion of ≤ 46 mm (by visual observation) in routine clinical settings in Japan.

Detailed description: In these days, meta-analyses have been conducted in large scale and small scale studies, but there has been no conclusion yet stating which one of the stents, either Cypher stent or TAXUS stent, is superior to the other. In specific disease condition such as in diabetic patients, it has been reported that Paclitaxel (TAXUS stent) is more suitable than Sirolimus (Cypher stent), due to the difference in the action mechanisms of the drugs. Since TAXUS stent was recently approved in Japan, we decided to conduct a randomized multi-center comparative study to compare Cypher stent and TAXUS stent regarding the clinical endpoint (target vessel failure for 8 months). The study is powered to show equivalence between the 2 stents in all patients, and to show superiority of the TAXUS stent in the diabetic patient population. In addition, for selected patients, quantitative coronary angiography, intravascular ultrasound, optical coherence tomography, and angioscopy are performed to examine the difference of the two stents more closely.

Eligibility criteria: Inclusion Criteria:

* Patient is ≥ 20 years old
* Patient suitable for percutaneous coronary intervention (PCI)
* Patient with signed informed consent
* Patient judged suitable to receive anti-platelet drugs (clopidogrel bisulfate or ticlopidine hydrochloride, etc.) in principle for at least 6 months after procedure, and ideally up to 12 months in patients who are not at high risk of bleeding, based on ACC/AHA guideline
* Patient with up to 3 lesions (with ≥ 50% of stenosis) in the maximum of 2 targeted vessels to be treated at once
* Patient with reference vessel diameter (RVD) of 2.5 mm to 3.75 mm by visual observation
* Patient with length of each lesion of up to 46 mm by visual assessment
* Patient eligible for implementation of drug eluting stent.

Exclusion Criteria:

* Patient with any planned treatment in the targeted vessel with a drug eluting stent other than in this study
* Patient with acute myocardial infarction (AMI) (including non-ST segment elevation MI) developed within 7 days before the procedure
* Patient participating in a currently ongoing registry or clinical study, or receiving a treatment which may affect the endpoints of this study
* Patient of childbearing potential with a positive pregnancy test within 14 days before the procedure, or lactating
* Patient who has history of allergy against Sirolimus, Paclitaxel, polymers or stainless steel
* Patient who has history of side-effect against anti-platelet drugs or anti-coagulation drugs
* Patient with serious hepatic dysfunction
* Patient with left ventriculogram ejection fraction of 35% or less
* Patient with three target vessels in need of PCI treatment
* Patient with serious renal dysfunction (serum creatinine value 2mg/dL or higher)
* Patient currently receiving artificial dialysis
* Patient with a malignant tumor (cancer) diagnosed within 5 years before the procedure
* Patient who has received PCI treatment within the past one year
* Patient with chronic total occlusion (CTO) or TIMI flow 2 or less
* Patient with \>50% stenosis in left main coronary artery
* Patient with \>50% stenosis in side branch ostial for which stenting in the side branch lesion is required (KBT for side branch is accepted)
* Patient with in-stent restenosis in the target lesion implanted with a bare-metal or drug eluting stent
* Patient who has target lesion in saphenous vein graft
* Patient judged non-eligible by the physician in charge.

Primary outcomes:
measure: Target Vessel Failure (TVF) at 8 months post-procedure(assessed prior to routine angiography) in Overall study population
timeFrame: 8 months
Secondary outcomes:
measure: Target Vessel Failure (TVF) at 8 months post-procedure (assessed prior to routine angiography) in diabetic group
timeFrame: 8 months
Other outcomes:
Locations:
city: Aichi
country: Japan
facility: Aichi Medical University Hospital
city: Amagasaki
country: Japan
facility: Japan Labour Health and Welfare Organization, Kansai Rosai Hospital
city: Asahikawa
country: Japan
facility: Asahikawa-Kosei General Hospital
city: Fuchu
country: Japan
facility: Sakakibara Memorial Hospital
city: Fukui
country: Japan
facility: Fukui Cardiovascular Center
city: Fukuoka
country: Japan
facility: Fukuoka University Hospital
city: Gifu
country: Japan
facility: Gifu Prefectural General Medical Center
city: Hamamatsu
country: Japan
facility: Seirei Hamamatsu General Hospital
city: Hekinan
country: Japan
facility: Hekinan Municipal Hospital
city: Hidaka
country: Japan
facility: Saitama Medical University International Medical Center
city: Higashiomi
country: Japan
facility: Koto Memorial Hospital
city: Hirakata
country: Japan
facility: Kansai Medical University Hirakata Hospital
city: Hiratsuka
country: Japan
facility: Hiratsuka Kyosai Hospital
city: Hirosaki
country: Japan
facility: Hirosaki University School of Medicine and Hospital
city: Hiroshima
country: Japan
facility: Hiroshima University Hospital
city: Hiroshima
country: Japan
facility: Tsuchiya General Hospital
city: Iizuka
country: Japan
facility: Iizuka Hospital
city: Imabari
country: Japan
facility: Saiseikai Imabari Hospital
city: Inzai
country: Japan
facility: Nippon Medical School Chiba Hokusoh Hospital
city: Iwaki
country: Japan
facility: Iwaki Kyoritsu Hospital
city: Izumisano
country: Japan
facility: Rinku General Medical Center
city: Izunokuni
country: Japan
facility: Juntendo University Shizuoka Hospital
city: Kadoma
country: Japan
facility: Setsunan General Hospital
city: Kanazawa
country: Japan
facility: Ishikawa Prefectural Central Hospital
city: Kanazawa
country: Japan
facility: Kanazawa Cardiovascular Hospital
city: Kashihara
country: Japan
facility: Nara Medical University Hospital
city: Kawasaki
country: Japan
facility: Japan Labour Health and Welfare Organization, Kanto Rosai Hospital
city: Kawasaki
country: Japan
facility: Kawasaki Saiwai Hospital
city: Kida
country: Japan
facility: Kagawa University Hospital
city: Kisarazu
country: Japan
facility: Kimitsu Chuo Hospital
city: Kitakyusyu
country: Japan
facility: Kokura Memorial Hospital
city: Kobe
country: Japan
facility: Kobe University Hospital
city: Kochi
country: Japan
facility: Chikamori Hospital
city: Koriyama
country: Japan
facility: Hoshi General Hospital
city: Kumamoto
country: Japan
facility: Kumamoto Chuo Hospital
city: Kumamoto
country: Japan
facility: Saiseikai Kumamoto Hospital
city: Kurashiki
country: Japan
facility: Kawasaki Medical School Hospital
city: Kurume
country: Japan
facility: Kurume University Hospital
city: Kurume
country: Japan
facility: St.Mary's Hospital
city: Kyoto
country: Japan
facility: Japanese Red Cross Kyoto Daini Hospital
city: Kyoto
country: Japan
facility: Koseikai Takeda Hospital
city: Kyoto
country: Japan
facility: Kyoto-Katsura Hospital
city: Mie
country: Japan
facility: Mie Heart Center
city: Miki
country: Japan
facility: Miki City Hospital
city: Miyazaki
country: Japan
facility: Miyazaki Medical Association Hospital
city: Morioka
country: Japan
facility: Memorial Heart Center Iwate Medical University
city: Moriyama
country: Japan
facility: Shiga Medical Center for Adults
city: Musashino
country: Japan
facility: Musashino Red Cross Hospital
city: Nagaoka
country: Japan
facility: Tachikawa General Hospital
city: Nagasaki
country: Japan
facility: Kouseikai Hospital
city: Nagoya
country: Japan
facility: Nagoya daiichi red cross Hospital
city: Nagoya
country: Japan
facility: Nagoya Daini Red Cross Hospital
city: Nagoya
country: Japan
facility: Nagoya Memorial Hospital
city: Ogaki
country: Japan
facility: Ogaki Municipal Hospital
city: Oita
country: Japan
facility: Oita Cardiovascular Hospital
city: Oita
country: Japan
facility: OitaOka Hospital
city: Okayama
country: Japan
facility: Okayama Red Cross General Hospital
city: Okayama
country: Japan
facility: Okayama University Hospital
city: Okayama
country: Japan
facility: Sakakibara Heart Institute of Okayama
city: Omihachiman
country: Japan
facility: Omihachiman Community Medical Center
city: Osaka
country: Japan
facility: National Hospital Organization Osaka National Hospital
city: Osaka
country: Japan
facility: Osaka City University Hospital
city: Osaka
country: Japan
facility: Osaka General Medical Center
city: Osaka
country: Japan
facility: Osaka Police Hospital
city: Sagamihara
country: Japan
facility: Kitasato University Hospital
city: Saitama
country: Japan
facility: Iwatsuki-minami Hospital
city: Sakai
country: Japan
facility: Japan Labour Health and Welfare Organization, Osaka Rosai Hospital
city: Sapporo
country: Japan
facility: Caress Sapporo Hokko Memorial Hospital
city: Sapporo
country: Japan
facility: Caress Sapporo Tokeidai Hospital
city: Sapporo
country: Japan
facility: Hokkaido Social Insurance Hospital
city: Sapporo
country: Japan
facility: Sapporo Orthopaedic Cardio-vascular Hospital
city: Sapporo
country: Japan
facility: Teine Keijinkai Hospital
city: Sendai
country: Japan
facility: Sendai Kousei Hospital
city: Sendai
country: Japan
facility: Sendai Open Hospital
city: Sendai
country: Japan
facility: Tohoku Koseinenkin Hospital
city: Shimotsuke
country: Japan
facility: Jichi Medical University Hospital
city: Suita
country: Japan
facility: National Cerebral and Cardiovascular Center
city: Suita
country: Japan
facility: Osaka University Graduate School of Medicine
city: Takamatsu
country: Japan
facility: Kagawa Prefectural Central Hospital
city: Tokyo
country: Japan
facility: Ayase Heart Hospital
city: Tokyo
country: Japan
facility: Edogawa Hospital
city: Tokyo
country: Japan
facility: Itabashi Chuo Medical Center
city: Tokyo
country: Japan
facility: Jikei University Hospital
city: Tokyo
country: Japan
facility: Juntendo University Hospital
city: Tokyo
country: Japan
facility: Juntendo University Nerima Hospital
city: Tokyo
country: Japan
facility: Kanto Medical Center NTT EC
city: Tokyo
country: Japan
facility: Keio University Hospital
city: Tokyo
country: Japan
facility: Mitsui Memorial Hospital
city: Tokyo
country: Japan
facility: Nihon University School of Medicine Itabashi Hospital
city: Tokyo
country: Japan
facility: Nippon Medical School Hospital
city: Tokyo
country: Japan
facility: Showa University Hospital
city: Tokyo
country: Japan
facility: St. Luke's International Hospital
city: Tokyo
country: Japan
facility: Teikyo University Hospital
city: Tokyo
country: Japan
facility: The Cardiovascular Institute Hospital
city: Tokyo
country: Japan
facility: Toho University Ohashi Medical Center
city: Tokyo
country: Japan
facility: Toho University Omori Medical Center
city: Tokyo
country: Japan
facility: Tokyo Medical University Hospital
city: Tokyo
country: Japan
facility: Tokyo Metropolitan Hiroo Hospital
city: Tokyo
country: Japan
facility: Tokyo Women's Medical University Hospital
city: Tokyo
country: Japan
facility: Toranomon Hospital
city: Tomishiro
country: Japan
facility: Tomishiro Central Hospital
city: Toyama
country: Japan
facility: Toyama Prefectural Central Hospital
city: Toyama
country: Japan
facility: Toyama Red Cross Hospital
city: Toyoake
country: Japan
facility: Fujita Health University Hospital
city: Toyohashi
country: Japan
facility: Toyohashi Heart Center
city: Tsuchiura
country: Japan
facility: Tsuchiura Kyodo Hospital
city: Tsuyama
country: Japan
facility: Tsuyama Central Hospital
city: Uwajima
country: Japan
facility: Uwajima City Hospital
city: Wakayama
country: Japan
facility: Wakayama Medical University Hospital
city: Yamagata
country: Japan
facility: Yamagata Prefectural Central Hospital
city: Yamaguchi
country: Japan
facility: Saiseikai Yamaguchi Hospital
city: Yatsushiro
country: Japan
facility: Japan Labour Health and Welfare Organization, Kumamoto Rosai hospital
city: Yokohama
country: Japan
facility: Japan Labour Health and Welfare Organization, Yokohama Rosai Hospital
city: Yokohama
country: Japan
facility: Kanagawa Cardiovascular and Respiratory Center
city: Yokohama
country: Japan
facility: Kikuna Memorial Hospital
city: Yokohama
country: Japan
facility: Saiseikai Yokohamashi Tobu Hospital
city: Yokohama
country: Japan
facility: Showa University Fujigaoka Hospital
city: Yokohama
country: Japan
facility: Showa University Northern Yokohama Hospital
city: Yokohama
country: Japan
facility: Yokohama City University General Medical Center
city: Yokohama
country: Japan
facility: Yokohama Sakae Kyosai Hospital
city: Yokosuka
country: Japan
facility: Yokosuka General Hospital Uwamachi
city: Yonago
country: Japan
facility: Tottori University Hospital
Study officials:
affiliation: Non-profit organization(NPO); "Associations for Establishment of Evidence in Intervations"
name: Shinsuke Nanto, M.D
role: STUDY_CHAIR
References: