Care China-Diabetes

This study has been terminated.
(the product was delisted.)
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Medical, China
ClinicalTrials.gov Identifier:
NCT00938119
First received: June 24, 2009
Last updated: June 27, 2013
Last verified: July 2011
  Purpose

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.


Condition
Cardiovascular Disease
Diabetes

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Medical, China:

Primary Outcome Measures:
  • MACE (clinically driven TLR, cardiac death, MI, ST) at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • ARC (probable + definite) ST at 1-day, and 1 and 12 months [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   None Retained

Diabetes patient


Enrollment: 1603
Study Start Date: August 2009
Study Completion Date: December 2012
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Diabetes patients with PCI
this is single group

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00938119

  Show 46 Study Locations
Sponsors and Collaborators
Johnson & Johnson Medical, China
Investigators
Principal Investigator: Yang Yue Jin, MD, Phd Cardiovascular Institute & Fu Wai Hospital
Principal Investigator: Lv Shu Zheng, MD Beijing Anzhen Hospital of the Capital University of Medical Sciences
Principal Investigator: Chen Yun Dai, MD, Phd Chinese PLA General Hospital
Principal Investigator: Wang Le feng Beijing Chaoyang Hospital Affiliated to the Capital University of Medical Sciences
Principal Investigator: Gao Wei, MD, Phd Peking University Third Hospital
Principal Investigator: Wang Wei Min, MD, PhD Peking University People's Hospital
Principal Investigator: Huo Yong, MD, PhD Peking University First Hospital
Principal Investigator: Fang Quan, MD, PhD Peking Union Medical College Hospital
Principal Investigator: He Qing, MD, PhD Beijing Hospital
Principal Investigator: Liu Hui Liang, MD General Hospital of Armed Police Forces
Principal Investigator: Li Hui, MD General Hospital of Daqing Oilfield
Principal Investigator: Chen Ji Yan, MD, PhD Guangdong General Hospital
Principal Investigator: Du Zhi Min, MD First Affiliated Hospital, Sun Yat-Sen University
Principal Investigator: Hou Yu Qing, MD NanFang Hospital Affiliated to Southern Medical University
Principal Investigator: Li Wei Min, MD First Affiliated Hospital of Harbin Medical University
Principal Investigator: Yu Bo, MD The Second Affiliated Hospital of Harbin Medical University
Principal Investigator: Fu Guo Sheng, MD Sir Run Run Shaw Hospital Affiliated with School of Medicine,Zhejiang University
Principal Investigator: Wang Jian An, MD, PhD Second Affiliated Hospital, School of Medicine, Zhejiang University
Principal Investigator: Zhu Jian Hua, MD First Affiliated Hospital of Zhejiang University College of Medicine
Principal Investigator: Liu Bin, MD The Second Affiliated Hospital of Jilin University
Principal Investigator: Cui Lian Qun, MD, PhD Shandong Provincial Hospital
Principal Investigator: Zhang Zheng, MD, PhD Lanzhou University First Hospital
Principal Investigator: Chen Shao Liang, MD, PhD Nanjing First Hospital
Principal Investigator: Xu Biao, MD Nanjing Drum Tower Hospital
Principal Investigator: Li Lang, MD, PhD Guangxi Medical University
Principal Investigator: Ge Jun Bo, MD, PhD Fudan University
Principal Investigator: He Ben, MD,PhD Shanghai Jiaotong University School of Medicine affiliated Renji Hospital
Principal Investigator: Shen Wei Feng, MD, PhD Shanghai Jiaotong University School of Medicine affiliated Ruijin Hospital
Principal Investigator: Xu Ya Wei, MD, PhD Shanghai Tenth People's Hospital of Tongji University
Principal Investigator: Han Ya Ling, MD, PhD General Hospital of Shenyang Military Region
Principal Investigator: Pang Wen Yue, MD, PhD Shengjing Hospital
Principal Investigator: Li Bao, MD,PhD Shanxi Cardiovascular Hospital
Principal Investigator: Lv Ji Yuan, MD The First Hospital of Shanxi Medical University
Principal Investigator: Liu Yin, MD, PhD Tian Jin Chest Hospital
Principal Investigator: Qi Xiang Qian, MD Teda International Cardiovascular Hospital
Principal Investigator: Jiang Tie Min, MD The Affiliated Hospital of Medical College of Chinese Armed Police Forces
Principal Investigator: Lu Cheng Zhi, MD Tianjin First Center Hospital
Principal Investigator: Huang Wei Jian, MD, PhD Wenzhou Medical University
Principal Investigator: Sun Ying Xian, MD China Medical University, China
Principal Investigator: Li Guo Qing, MD People's Hospital Of XinJiang Uygur Autonomous Region
Principal Investigator: Yuan Zu Yi, MD The First Hospital of Xian Jiao Tong University
Principal Investigator: Wang Hai Chang, MD Xijing Hospital
Principal Investigator: Wang Yan, MD,PhD Zhongshan Hospital Xiamen University
Principal Investigator: Gao Chuan Yu, MD, PhD Henan Provincial Hospital
Principal Investigator: Wang Chun, MD, PhD Peking University, Shen Zhen Hospital
Principal Investigator: Yong Wang, MD, PhD China-Japan Friendship Hospital
  More Information

No publications provided

Responsible Party: Johnson & Johnson Medical, China
ClinicalTrials.gov Identifier: NCT00938119     History of Changes
Other Study ID Numbers: CDS-200801
Study First Received: June 24, 2009
Last Updated: June 27, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Johnson & Johnson Medical, China:
Cardiovascular disease
Diabetes

Additional relevant MeSH terms:
Cardiovascular Diseases
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on October 29, 2014