Care China-Diabetes
- Conditions
- Cardiovascular DiseaseDiabetes
- Registration Number
- NCT00938119
- Lead Sponsor
- Johnson & Johnson Medical, China
- Brief Summary
This multicenter, prospective, observational registry will assess efficacy and safety outcomes associated with percutaneous coronary intervention (PCI) with implantation of the CYPHER Selectβ’+ Sirolimus-eluting Coronary Stents in Chinese diabetic patients with coronary artery disease in routine clinical practice.
- Detailed Description
The study objective is to assess the incidences of major adverse cardiovascular events (MACE; defined as a composite of clinically driven target-lesion revascularization, cardiac death, any myocardial infarction, and stent thrombosis) at 12-month follow-up, and of stent thrombosis at 1-day, and 1- and 12-month follow-up. Pre-specified analyses will be performed among patient subpopulations according to level of glycemic control (HbA1c level \< 6.5% or \> 6.5%); reference vessel diameter by quantitative coronary angiography (\< 2.5 mm and \> 2.5 mm); and stented length (8-18 mm; 23-33 mm; and \>33 mm). Quantitative coronary angiographic (QCA) analysis will be performed at the core lab of the China Cardiovascular Research Foundation for all pre- and post-index procedure angiograms and during the 12-month follow-up period for the pre- and post-reintervention procedures in those cases of clinically-driven PCI revascularization. Also, multivariable analyses will be conducted to investigate potential predictors of 12-month MACE rate in routine clinical practice.
The registry will be conducted at about 45 centers in China, where the CYPHER Selectβ’+ Sirolimus-eluting Coronary Stent is commercially available. Data will be collected on 2,500 diabetic patients treated with the CYPHER Selectβ’ + Sirolimus-eluting Coronary Stent only.
Primary outcome: MACE (clinically driven TLR, cardiac death, MI, ST) at 12 months Secondary outcome: ARC (probable + definite) ST at 1-day, and 1 and 12 months
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 1603
- Patients between the ages of 18 and 80 (inclusive) receiving CYPHER SELECTβ’+ Sirolimus-eluting Coronary Stent according to standard clinical practice when financially feasible
- The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethics Committee of the respective clinical site.
- Patient has diagnosis of diabetes or is diagnosed with it before or during the index procedure hospitalization based on disease diagnosis criteria
- Any contraindication to any of the following medications: aspirin, heparin, thienopyridines (clopidogrel/ticlopidine), stainless steel, contrast agents, or sirolimus
- An elective surgical procedure is planned that would necessitate interruption of antiplatelet drugs during the first 6 months post enrollment
- Cardiogenic shock
- Terminal illness with life expectancy <1 year
- ST-segment elevation myocardial infarction within 7 days prior to the index procedure
- Any patient who received coronary stent(s) within 1 year
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method MACE (clinically driven TLR, cardiac death, MI, ST) at 12 months 12 months
- Secondary Outcome Measures
Name Time Method ARC (probable + definite) ST at 1-day, and 1 and 12 months 12 months
Trial Locations
- Locations (46)
The First Hospital of China Medical University
π¨π³Shenyang, Liaoning, China
Xijing Hospital
π¨π³Xian, Shanxi, China
Guangdong General Hospital
π¨π³Guangzhou, Guangdong, China
Cardiovascular Institute & Fu Wai Hospital
π¨π³Beijing, China
Xuan Wu Hospital Capital Medical University
π¨π³Beijing, Beijing, China
Peking University, Shenzhen Hospital
π¨π³Guangdong, Guangdong, China
The First Affiliated Hospital of Harbin Medical University
π¨π³Harbin, Heilongjiang, China
Peking University People's Hospital
π¨π³Beijing, Beijing, China
The General Hospital of the People's Liberation Army
π¨π³Beijing, Beijing, China
China-Japan Friendship Hospital
π¨π³Beijng, Beijing, China
The Second Affiliated Hospital of Jilin University
π¨π³Changchun, Jilin, China
The Affiliated Hospital Of Medical College Qingdao University
π¨π³Qingdao, Shandong, China
General Hospital of Daqing Oilfield
π¨π³Da Qing, China
The Affiliated Hospital of Medical College of Chinese Armed Police Forces
π¨π³Tianjin, China
The First Affiliated Hospital of Wenzhou Medical College
π¨π³Wenzhou, China
Beijing Anzhen Hospital of the Capital University of Medical Science
π¨π³Beijing, Beijing, China
Beijing Hospital
π¨π³Beijing, Beijing, China
Second Affiliated Hospital of Zhejiang University College of Medicine
π¨π³Hangzhou, Zhejiang, China
Lanzhou University First Hospita
π¨π³Lanzhou, Gansu, China
Tian Jin Chest Hospital
π¨π³Tianjin, Tianjin, China
People's Hospital Of XinJiang Uygur Autonomous Region
π¨π³Urumuqi, Xinjiang, China
Sir Run Run Shaw Hospital
π¨π³Hang Zhou, China
The First Hospital of Xian Jiao Tong University
π¨π³Xi'an, China
NanFang Hospital Affiliated to Southern Medical University
π¨π³Guangzhou, Guangdong, China
Peking University Third Hospital
π¨π³Beijing, Beijing, China
Zhongshan Hospital Xiamen University
π¨π³Xiamen, Fujian, China
Shandong Provincial Hospital
π¨π³Jinan, China
Shengjing Hospital of China Medical University
π¨π³Shen Yang, China
Peking Union Medical College Hospital
π¨π³Beijing, Beijing, China
The General Hospital of Shenyang Military Command
π¨π³Shenyang, Liaoning, China
Peace Hospital
π¨π³ShiJiaZhuang, Hebei, China
Shanxi Cardiovascular Hospital
π¨π³Taiyuan, Shanxi, China
The First Hospital of Shanxi Medical University
π¨π³Taiyuan, Shanxi, China
General Hospital of Armed Police Forces
π¨π³Beijing, Beijing, China
Beijing Chaoyang Hospital
π¨π³Beijing, Beijing, China
Zhongshan Hospital Fudan University
π¨π³Shanghai, Shanghai, China
Shanghai Jiaotong University School of Medicine affiliated Renji Hospital
π¨π³Shanghai, Shanghai, China
Henan Provincial People's Hospital
π¨π³Zhengzhou, Henan, China
Tianjin First Center Hospital
π¨π³Tianjin, Tianjin, China
Shanghai Tenth People's Hospital of Tongji University
π¨π³Shanghai, China
Teda International Cardiovascular Hospital
π¨π³Tianjin, China
Nanjing First Hospital
π¨π³Nanjing, Jiangsu, China
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
π¨π³Shanghai, Shanghai, China
The First Affiliated Hospital,Sun Yat-Sen University
π¨π³Guangzhou, Guangdong, China
Beijing Tongren Hospital affiliated to Capital Medical University
π¨π³Beijing, Beijing, China
Beijing Friendship Hospital
π¨π³Beijing, Beijing, China