Plain English Summary
Background and study aims?
Diabetes mellitus (DM) is associated with increased cardiovascular morbidity and mortality. Coronary artery disease (CAD) is the most common cause of cardiovascular morbidity and mortality. There are four times as many cardiovascular deaths in diabetic patients compared to non-diabetic patients. In particular, after acute coronary syndrome or heart attacks, patients with DM have been reported to have worse survival rates compared to those without DM. Hyperglycemia (high blood sugar) is an important predictor of long-term outcomes after acute coronary events. The management of many risk factors including blood pressure and cholesterol has been shown to reduce these complications in patients with type 2 DM. Therefore, lifestyle changes and management of hyperglycemia is recommended in current clinical guidelines. To reach this goal, combining therapy with oral anti-diabetic drugs (OADs) is very common.
The study aimed at investigating the relationship between anti-diabetic drugs and the outcomes of acute coronary syndrome.
Who can participate?
Diabetic patients aged 20 years or older, who are hospitalized due to acute coronary syndrome
What does the study involve?
The study will collect clinical information related to acute coronary syndrome by reviewing medical records or interviewing with the patients at regular intervals.
What are the possible benefits and risks of participating? The participation of patients will benefit in the exploration of knowledge about the impact of OADs on the outcomes of acute coronary syndrome. There are no known risks to participants taking part in this study.
Where is the study run from?
Taiwan Society of Cardiology, Taipei (Taiwan)
When is the study starting and how long is it expected to run for?
July 2013 to January 2017
Who is funding the study?
Taiwan Society of Cardiology (Taiwan)
Who is the main contact?
Prof. Kuo-Gi Hsyu
m002018@ms.skh.org.tw
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
102-051-E
Study information
Scientific title
A prospective observational study of cardiovascular morbidity and mortality of acute coronary syndrome in patients with type 2 diabetes receiving different oral anti-diabetic drugs (OADs)
Acronym
Study hypothesis
The aim of the study is to evaluate the relations between anti-diabetic drugs and the outcomes after acute coronary syndrome
Ethics approval
IRB of National Taiwan University Hospital, Hsinchu Br., 01/11/2013, IRB No.102-051-E
Study design
Observational cohort study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Not Specified
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Diabetic patients with acute coronary syndrome
Intervention
After enrolment, the participants will be reviewed by medical records and interview as needed, at enrolment, discharge, and 1, 6, 12, 24 months after discharge, to collect information related to acute coronary syndrome, including mortality, myocardial infarction, hospitalisation and cardiovascular death. The total duration of follow-up was 24 months after enrolment.
Intervention type
Drug
Phase
Not Specified
Drug names
Primary outcome measure
Cumulative one-year mortality, assessed by reviewing medical records and interviews with patients at the baseline, discharge and 1, 6, 12 and 24 months after discharge
Secondary outcome measures
The following will be assessed by reviewing medical records and interviews with patients at the baseline, discharge and 1, 6, 12 and 24 months after discharge:
1. In hospital outcome
2. Cumulative one-year cardiovascular events
Overall trial start date
01/07/2013
Overall trial end date
18/01/2017
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged 20 years or older
2. Diagnosed with acute coronary syndrome within 30 days prior to enrolment
3. Type 2 diabetes mellitus (newly or previously diagnosed)
4. Provided informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
2000
Participant exclusion criteria
1. Acute coronary syndrome caused by major trauma, GI bleeding, surgery, or endovascular interventions
2. Participating in other clinical trials
Recruitment start date
01/11/2013
Recruitment end date
30/09/2016
Locations
Countries of recruitment
Taiwan
Trial participating centre
Taiwan; National Taiwan University Hospital
No. 7號
Zhongshan South Road
Zhongzheng District
Taipei City
100
Taiwan
Trial participating centre
Mac Kay Memorial Hospital
No. 92號
Section 2
Zhongshan N Rd
Zhongshan District,
Taipei City
101
Taiwan
Trial participating centre
Taipei Veterans General Hospital
No. 201
Section 2
Shipai Road
Beitou District
Taipei City
112
Taiwan
Trial participating centre
Shin Kong Wu Ho-Su Memorial Hospital
No. 95
Wenchang Road
Shilin District
Taipei City
112
Taiwan
Trial participating centre
Tri-Service General Hospital
No. 325
Section 2
Chenggong Road
Neihu District
Taipei City
114
Taiwan
Trial participating centre
Wan fang Hospital
No. 111號
Section 3
Xinglong Road
Wenshan District
Taipei City
116
Taiwan
Trial participating centre
Cheng Hsin General Hospital
No. 45號
Zhenxing Street
Beitou District
Taipei City
112
Taiwan
Trial participating centre
Cathay General Hospital
No. 280號
Section 4
Ren'ai Road
Da’an District
Taipei City
106
Taiwan
Trial participating centre
Far Eastern Memorial Hospital
No. 21號
Section 2
Nanya South Road
Banqiao District
New Taipei City
220
Taiwan
Trial participating centre
Shuang Ho Hospital
No. 291
Zhongzheng Road
Zhonghe District
New Taipei City
235
Taiwan
Trial participating centre
Lin kou Chang Gung Memorial Hospital
No. 5
Fuxing Street
Guishan District
Taoyuan City
333
Taiwan
Trial participating centre
Taipei Tzu Chi Hospital
No. 289
Jianguo Road
Xindian District
New Taipei City
231
Taiwan
Trial participating centre
Lo-Tung Poh-Ai Hospital
No. 83, Nanchang Street
Luodong Township
Yilan County
265
Taiwan
Trial participating centre
Yang-Ming University Hospital
No. 152
Xinmin Road
Yilan City
Yilan County
260
Taiwan
Trial participating centre
Chung-Shan Medical University Hospital
No. 110號
Section 1
Jianguo North Road
South District
Taichung City
402
Taiwan
Trial participating centre
China Medical University Hospital
No. 2號
Yude Road
North District
Taichung City
404
Taiwan
Trial participating centre
Taichung Veterans General Hospital
No. 1650號
Section 4
Taiwan Boulevard
Xitun District
Taichung City
407
Taiwan
Trial participating centre
Yunlin Branch, Taiwan; National Taiwan University Hospital
No. 579
Sec. 2
Yun-Lin Rd.
Douliou City
640
Taiwan
Trial participating centre
Kuang Tien General Hospital
No. 117
Shatian Road
Shalu District
Taichung City
433
Taiwan
Trial participating centre
National Cheng Kung University Hospital
No. 138號
Shengli Road
North District
Tainan City
704
Taiwan
Trial participating centre
Chi mei Medical Center
No.901
Zhonghua Rd.
Yongkang Dist.
Tainan City
710
Taiwan
Trial participating centre
Chang Gung Memorial Hospital, Kaohsiung
No. 123號
Dapi Road
Niaosong District
Kaohsiung City
833
Taiwan
Trial participating centre
Kaohsiung Veterans General Hospital
No. 386號
Dazhong 1st Road
Zuoying District
Kaohsiung City
813
Taiwan
Trial participating centre
E-Da Hospital, Kaohsiung
No.1
Yida Road
Jiaosu Village
Yanchao District
Kaohsiung City
821
Taiwan
Trial participating centre
Kaohsiung Medical University Hospital
No. 100號
Ziyou 1st Road
Sanmin District
Kaohsiung City
807
Taiwan
Trial participating centre
National Taiwan University Hospital, Hsinchu Branch
No. 25
Lane 442
Section 1
Jingguo Road
North District
Hsinchu City
300
Taiwan
Trial participating centre
Ping Tung Christian Hospital
No. 60號
Dalian Road
Pingtung City
900
Taiwan
Sponsor information
Organisation
Taiwan Society of Cardiology
Sponsor details
13F-1
No. 11
Min-Chuan W. Road
Taipei 10452
Taiwan
R.O.C
Taipei
104
Taiwan
886-2-2597-6177
tsoc@tsoc.org.tw
Sponsor type
Not defined
Website
Funders
Funder type
Not defined
Funder name
investigator initiated and funded
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Publication in a high-impact peer-reviewed journal is planned, two years after the overall end of the trial
Intention to publish date
18/01/2018
Participant level data
Other
Basic results (scientific)
Publication list