Cardiovascular DiseaseNCT00938119
Care China-Diabetes
An observational study of Cardiovascular Disease and Diabetes, run by Johnson & Johnson Medical, China at 46 sites in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cardiovascular Disease, Diabetes
- How many people
- 1,603 participants
- Where
- 46 sitesChina
- Study dates
- Aug 2009to Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
46 sites in 1 country.
46 sites in 1 country
China46 sites
Beijing Anzhen Hospital of the Capital University of Medical Science
Beijing, Beijing Municipality, 100029
General Hospital of Armed Police Forces
Beijing, Beijing Municipality, 100039
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Beijing Tongren Hospital affiliated to Capital Medical University
Beijing, Beijing Municipality, 100730
Beijing Chaoyang Hospital
Beijing, Beijing Municipality
Beijing Friendship Hospital
Beijing, Beijing Municipality
Beijing Hospital
Beijing, Beijing Municipality
Peking Union Medical College Hospital
Beijing, Beijing Municipality
Peking University Third Hospital
Beijing, Beijing Municipality
The General Hospital of the People's Liberation Army
Beijing, Beijing Municipality
Xuan Wu Hospital Capital Medical University
Beijing, Beijing Municipality
Cardiovascular Institute & Fu Wai Hospital
Beijing, 100037
China-Japan Friendship Hospital
Beijng, Beijing Municipality, 100029
The Second Affiliated Hospital of Jilin University
Changchun, Jilin
General Hospital of Daqing Oilfield
Daqing
Peking University, Shenzhen Hospital
Guangdong, Guangdong
NanFang Hospital Affiliated to Southern Medical University
Guangzhou, Guangdong, 510515
Guangdong General Hospital
Guangzhou, Guangdong
The First Affiliated Hospital,Sun Yat-Sen University
Guangzhou, Guangdong
Second Affiliated Hospital of Zhejiang University College of Medicine
Hangzhou, Zhejiang, 310009
Sir Run Run Shaw Hospital
Hangzhou, 310016
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang
Shandong Provincial Hospital
Jinan, 250021
Lanzhou University First Hospita
Lanzhou, Gansu
Nanjing First Hospital
Nanjing, Jiangsu
The Affiliated Hospital Of Medical College Qingdao University
Qingdao, Shandong
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, 200032
Shanghai Jiaotong University School of Medicine affiliated Renji Hospital
Shanghai, Shanghai Municipality
Shanghai Tenth People's Hospital of Tongji University
Shanghai, 200072
The General Hospital of Shenyang Military Command
Shenyang, Liaoning, 110015
The First Hospital of China Medical University
Shenyang, Liaoning
Shengjing Hospital of China Medical University
Shenyang, 110004
Peace Hospital
Shijiazhuang, Hebei, 050082
Shanxi Cardiovascular Hospital
Taiyuan, Shanxi, 030001
The First Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030001
Tian Jin Chest Hospital
Tianjin, Tianjin Municipality
Tianjin First Center Hospital
Tianjin, Tianjin Municipality
Teda International Cardiovascular Hospital
Tianjin
The Affiliated Hospital of Medical College of Chinese Armed Police Forces
Tianjin
People's Hospital Of XinJiang Uygur Autonomous Region
Urumuqi, Xinjiang
The First Affiliated Hospital of Wenzhou Medical College
Wenzhou, 325000
The First Hospital of Xian Jiao Tong University
Xi'an, 710061
Zhongshan Hospital Xiamen University
Xiamen, Fujian
Xijing Hospital
Xian, Shanxi
Henan Provincial People's Hospital
Zhengzhou, Henan, 450000
About this study
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
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.
Read the 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
- Conditions
- Cardiovascular Disease, Diabetes
- Keywords
- Cardiovascular disease, Diabetes
- Medical subject headings
- Cardiovascular Diseases, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Diabetes patients with PCI | this is single group |
What is being measured
The primary outcome is the main question the study is designed to answer.
MACE (clinically driven TLR, cardiac death, MI, ST) at 12 months
Measured: 12 months
Secondary outcomes (1)
ARC (probable + definite) ST at 1-day, and 1 and 12 months
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2009 (estimated)
- Study startAug 2009
- Primary completionNov 2011
- Study completionDec 2012
Why it stopped: the product was delisted.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,603 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Medical, China
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yang Yue Jin, MD, Phd, Principal investigator, Cardiovascular Institute & Fu Wai HospitalLv Shu Zheng, MD, Principal investigator, Beijing Anzhen Hospital of the Capital University of Medical SciencesChen Yun Dai, MD, Phd, Principal investigator, Chinese PLA General HospitalWang Le feng, Principal investigator, Beijing Chaoyang Hospital Affiliated to the Capital University of Medical SciencesGao Wei, MD, Phd, Principal investigator, Peking University Third HospitalWang Wei Min, MD, PhD, Principal investigator, Peking University People's HospitalHuo Yong, MD, PhD, Principal investigator, Peking University First HospitalFang Quan, MD, PhD, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00938119
- Sponsor's protocol ID
- CDS-200801
- Status last verified
- Jul 2011
- First submitted
- 24 Jun 2009
- Last updated
- 28 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00938119
- Acronym / sponsor ID
- CDS-200801
- Conditions
- Cardiovascular Disease, Diabetes
- Keywords
- Cardiovascular disease, Diabetes
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: the product was delisted.
- Enrolment
- 1,603 participants (actual)
- Lead sponsor
- Johnson & Johnson Medical, ChinaIndustry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Nov 2011 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 13 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diabetes patients with PCI | – | –this is single group |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
MACE (clinically driven TLR, cardiac death, MI, ST) at 12 months
Time frame: 12 months
1 secondary outcome
ARC (probable + definite) ST at 1-day, and 1 and 12 months
Time frame: 12 months
Results and safety
The study was stopped early (reason given: the product was delisted.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yang Yue Jin, MD, Phd principal investigator
Cardiovascular Institute & Fu Wai Hospital
Lv Shu Zheng, MD principal investigator
Beijing Anzhen Hospital of the Capital University of Medical Sciences
Chen Yun Dai, MD, Phd principal investigator
Chinese PLA General Hospital
46 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Disease and Diabetes, run by Johnson & Johnson Medical, China at 46 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 46 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: the product was delisted.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MACE (clinically driven TLR, cardiac death, MI, ST) at 12 months (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2013.