Condition category
Circulatory System
Date applied
12/09/2018
Date assigned
04/10/2018
Last edited
04/10/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Prof Kuo-Gi Hsyu

ORCID ID

Contact details

No. 95
Wen Chang Road
Shih Lin District
Taipei
112
Taiwan

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

http://www.tsoc.org.tw/

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

Publication citations

Additional files

Editorial Notes