Clinical trial NCT00938119: Care China-Diabetes
Official title: The Care China-Diabetes Registry A 12-month, Multi-centre, Prospective, Observational Registry Study to Investigate the Efficacy and Safety of CYPHER Select TM+ Sirolimus-eluting Coronary Stent Among Chinese Diabetic Patients With Coronary Artery Disease in Routine Clinical Practice
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cardiovascular Disease
Diabetes
Keywords: Cardiovascular disease
Diabetes
Lead sponsor: Johnson & Johnson Medical, China
Sponsor class: INDUSTRY
First posted: 2009-07-13
Enrollment: 1603
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The registry will be conducted at approximately 45 centers in China where the CYPHER SelectTM+ Sirolimus-eluting Coronary Stent is commercially available. Data will be collected on 2,500 diabetic patients treated only with the CYPHER Select™+ Sirolimus-eluting Coronary Stent during the index procedure. Enrolled diabetic patients are confirmed and diagnosed with Diabetes before or during the index procedure hospitalization, i.e., those receiving active treatment with an oral hypoglycemic agent or insulin, patients with diagnosis of diabetes who were on dietary therapy alone or patients with an abnormal blood glucose level after an overnight fast as defined by local standards.

Brief summary: This multicenter, prospective, observational registry will assess efficacy and safety outcomes associated with percutaneous coronary intervention (PCI) with implantation of the CYPHER Select™+ 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 Select™+ Sirolimus-eluting Coronary Stent is commercially available. Data will be collected on 2,500 diabetic patients treated with the CYPHER Select™ + 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

Eligibility criteria: Inclusion Criteria:

* Patients between the ages of 18 and 80 (inclusive) receiving CYPHER SELECT™+ 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

Exclusion 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

Primary outcomes:
measure: MACE (clinically driven TLR, cardiac death, MI, ST) at 12 months
timeFrame: 12 months
Secondary outcomes:
measure: ARC (probable + definite) ST at 1-day, and 1 and 12 months
timeFrame: 12 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital of the Capital University of Medical Science
state: Beijing
city: Beijing
country: China
facility: General Hospital of Armed Police Forces
state: Beijing
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Tongren Hospital affiliated to Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Chaoyang Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Friendship Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Hospital
state: Beijing
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
city: Beijing
country: China
facility: The General Hospital of the People's Liberation Army
state: Beijing
city: Beijing
country: China
facility: Xuan Wu Hospital Capital Medical University
state: Beijing
city: Beijng
country: China
facility: China-Japan Friendship Hospital
state: Beijing
city: Xiamen
country: China
facility: Zhongshan Hospital Xiamen University
state: Fujian
city: Lanzhou
country: China
facility: Lanzhou University First Hospita
state: Gansu
city: Guangdong
country: China
facility: Peking University, Shenzhen Hospital
state: Guangdong
city: Guangzhou
country: China
facility: NanFang Hospital Affiliated to Southern Medical University
state: Guangdong
city: Guangzhou
country: China
facility: Guangdong General Hospital
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hospital,Sun Yat-Sen University
state: Guangdong
city: ShiJiaZhuang
country: China
facility: Peace Hospital
state: Hebei
city: Harbin
country: China
facility: The First Affiliated Hospital of Harbin Medical University
state: Heilongjiang
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
state: Henan
city: Nanjing
country: China
facility: Nanjing First Hospital
state: Jiangsu
city: Changchun
country: China
facility: The Second Affiliated Hospital of Jilin University
state: Jilin
city: Shenyang
country: China
facility: The General Hospital of Shenyang Military Command
state: Liaoning
city: Shenyang
country: China
facility: The First Hospital of China Medical University
state: Liaoning
city: Qingdao
country: China
facility: The Affiliated Hospital Of Medical College Qingdao University
state: Shandong
city: Shanghai
country: China
facility: Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
state: Shanghai
city: Shanghai
country: China
facility: Zhongshan Hospital Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Jiaotong University School of Medicine affiliated Renji Hospital
state: Shanghai
city: Taiyuan
country: China
facility: Shanxi Cardiovascular Hospital
state: Shanxi
city: Taiyuan
country: China
facility: The First Hospital of Shanxi Medical University
state: Shanxi
city: Xian
country: China
facility: Xijing Hospital
state: Shanxi
city: Tianjin
country: China
facility: Tian Jin Chest Hospital
state: Tianjin
city: Tianjin
country: China
facility: Tianjin First Center Hospital
state: Tianjin
city: Urumuqi
country: China
facility: People's Hospital Of XinJiang Uygur Autonomous Region
state: Xinjiang
city: Hangzhou
country: China
facility: Second Affiliated Hospital of Zhejiang University College of Medicine
state: Zhejiang
city: Beijing
country: China
facility: Cardiovascular Institute & Fu Wai Hospital
city: Da Qing
country: China
facility: General Hospital of Daqing Oilfield
city: Hang Zhou
country: China
facility: Sir Run Run Shaw Hospital
city: Jinan
country: China
facility: Shandong Provincial Hospital
city: Shanghai
country: China
facility: Shanghai Tenth People's Hospital of Tongji University
city: Shen Yang
country: China
facility: Shengjing Hospital of China Medical University
city: Tianjin
country: China
facility: Teda International Cardiovascular Hospital
city: Tianjin
country: China
facility: The Affiliated Hospital of Medical College of Chinese Armed Police Forces
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical College
city: Xi'an
country: China
facility: The First Hospital of Xian Jiao Tong University
Study officials:
affiliation: Cardiovascular Institute & Fu Wai Hospital
name: Yang Yue Jin, MD, Phd
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing Anzhen Hospital of the Capital University of Medical Sciences
name: Lv Shu Zheng, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Chinese PLA General Hospital
name: Chen Yun Dai, MD, Phd
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing Chaoyang Hospital Affiliated to the Capital University of Medical Sciences
name: Wang Le feng
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking University Third Hospital
name: Gao Wei, MD, Phd
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking University People's Hospital
name: Wang Wei Min, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking University First Hospital
name: Huo Yong, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking Union Medical College Hospital
name: Fang Quan, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing Hospital
name: He Qing, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: General Hospital of Armed Police Forces
name: Liu Hui Liang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: General Hospital of Daqing Oilfield
name: Li Hui, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Guangdong Provincial People's Hospital
name: Chen Ji Yan, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: First Affiliated Hospital, Sun Yat-Sen University
name: Du Zhi Min, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Southern Medical University, China
name: Hou Yu Qing, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: First Affiliated Hospital of Harbin Medical University
name: Li Wei Min, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Second Affiliated Hospital of Harbin Medical University
name: Yu Bo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sir Run Run Shaw Hospital Affiliated with School of Medicine,Zhejiang University
name: Fu Guo Sheng, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Wang Jian An, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: First Affiliated Hospital of Zhejiang University College of Medicine
name: Zhu Jian Hua, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Second Affiliated Hospital of Jilin University
name: Liu Bin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Shandong Provincial Hospital
name: Cui Lian Qun, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lanzhou University First Hospital
name: Zhang Zheng, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Chen Shao Liang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
name: Xu Biao, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: First Affiliated Hospital of Guangxi Medical University
name: Li Lang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fudan University
name: Ge Jun Bo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Shanghai Jiaotong University School of Medicine affiliated Renji Hospital
name: He Ben, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Shanghai Jiaotong University School of Medicine affiliated Ruijin Hospital
name: Shen Wei Feng, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Shanghai Tenth People's Hospital of Tongji University
name: Xu Ya Wei, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: General Hospital of Shenyang Military Region
name: Han Ya Ling, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Shengjing Hospital
name: Pang Wen Yue, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Shanxi Cardiovascular Hospital
name: Li Bao, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital of Shanxi Medical University
name: Lv Ji Yuan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tian Jin Chest Hospital
name: Liu Yin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: TEDA International Cardiovascular Hospital
name: Qi Xiang Qian, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Affiliated Hospital of Medical College of Chinese Armed Police Forces
name: Jiang Tie Min, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tianjin First Central Hospital
name: Lu Cheng Zhi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: First Affiliated Hospital of Wenzhou Medical University
name: Huang Wei Jian, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: First Hospital of China Medical University
name: Sun Ying Xian, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: People's Hospital of Xinjiang Uygur Autonomous Region
name: Li Guo Qing, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Hospital of Xian Jiao Tong University
name: Yuan Zu Yi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Xijing Hospital
name: Wang Hai Chang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Zhongshan Hospital Xiamen University
name: Wang Yan, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Henan Provincial People's Hospital
name: Gao Chuan Yu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking University, Shen Zhen Hospital
name: Wang Chun, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: China-Japan Friendship Hospital
name: Yong Wang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: