Care China-Diabetes

Diabetes Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00938119
• Other study ID #: CDS-200801
• Status: Terminated
• Phase: N/A
• First received: June 24, 2009
• Last updated: June 27, 2013
• Start date: August 2009
• Est. completion date: December 2012

Study information

• Verified date: July 2011
• Source: Johnson & Johnson Medical, China
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1603
• Est. completion date: December 2012
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Diabetes

Locations

Country	Name	City	State
China	Beijing Anzhen Hospital of the Capital University of Medical Science	Beijing	Beijing
China	Beijing Chaoyang Hospital	Beijing	Beijing
China	Beijing Friendship Hospital	Beijing	Beijing
China	Beijing Hospital	Beijing	Beijing
China	Beijing Tongren Hospital affiliated to Capital Medical University	Beijing	Beijing
China	Cardiovascular Institute & Fu Wai Hospital	Beijing
China	General Hospital of Armed Police Forces	Beijing	Beijing
China	Peking Union Medical College Hospital	Beijing	Beijing
China	Peking University People's Hospital	Beijing	Beijing
China	Peking University Third Hospital	Beijing	Beijing
China	The General Hospital of the People's Liberation Army	Beijing	Beijing
China	Xuan Wu Hospital Capital Medical University	Beijing	Beijing
China	China-Japan Friendship Hospital	Beijng	Beijing
China	The Second Affiliated Hospital of Jilin University	Changchun	Jilin
China	General Hospital of Daqing Oilfield	Da Qing
China	Peking University, Shenzhen Hospital	Guangdong	Guangdong
China	Guangdong General Hospital	Guangzhou	Guangdong
China	NanFang Hospital Affiliated to Southern Medical University	Guangzhou	Guangdong
China	The First Affiliated Hospital,Sun Yat-Sen University	Guangzhou	Guangdong
China	Sir Run Run Shaw Hospital	Hang Zhou
China	Second Affiliated Hospital of Zhejiang University College of Medicine	Hangzhou	Zhejiang
China	The First Affiliated Hospital of Harbin Medical University	Harbin	Heilongjiang
China	Shandong Provincial Hospital	Jinan
China	Lanzhou University First Hospita	Lanzhou	Gansu
China	Nanjing First Hospital	Nanjing	Jiangsu
China	The Affiliated Hospital Of Medical College Qingdao University	Qingdao	Shandong
China	Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai
China	Shanghai Jiaotong University School of Medicine affiliated Renji Hospital	Shanghai	Shanghai
China	Shanghai Tenth People's Hospital of Tongji University	Shanghai
China	Zhongshan Hospital Fudan University	Shanghai	Shanghai
China	Shengjing Hospital of China Medical University	Shen Yang
China	The First Hospital of China Medical University	Shenyang	Liaoning
China	The General Hospital of Shenyang Military Command	Shenyang	Liaoning
China	Peace Hospital	ShiJiaZhuang	Hebei
China	Shanxi Cardiovascular Hospital	Taiyuan	Shanxi
China	The First Hospital of Shanxi Medical University	Taiyuan	Shanxi
China	Teda International Cardiovascular Hospital	Tianjin
China	The Affiliated Hospital of Medical College of Chinese Armed Police Forces	Tianjin
China	Tian Jin Chest Hospital	Tianjin	Tianjin
China	Tianjin First Center Hospital	Tianjin	Tianjin
China	People's Hospital Of XinJiang Uygur Autonomous Region	Urumuqi	Xinjiang
China	The First Affiliated Hospital of Wenzhou Medical College	Wenzhou
China	The First Hospital of Xian Jiao Tong University	Xi'an
China	Zhongshan Hospital Xiamen University	Xiamen	Fujian
China	Xijing Hospital	Xian	Shanxi
China	Henan Provincial People's Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Medical, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MACE (clinically driven TLR, cardiac death, MI, ST) at 12 months		12 months	Yes
Secondary	ARC (probable + definite) ST at 1-day, and 1 and 12 months		12 months	Yes