The impact of anti-diabetic drugs on the outcomes of heart attacks
| ISRCTN | ISRCTN77314261 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN77314261 |
| Secondary identifying numbers | 102-051-E |
- Submission date
- 12/09/2018
- Registration date
- 04/10/2018
- Last edited
- 04/10/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
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
Contact information
Scientific
No. 95, Wen Chang Road, Shih Lin District
Taipei
112
Taiwan
Study information
| Study design | Observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Not Specified |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| 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) |
| Study objectives | The aim of the study is to evaluate the relations between anti-diabetic drugs and the outcomes after acute coronary syndrome |
| Ethics approval(s) | IRB of National Taiwan University Hospital, Hsinchu Br., 01/11/2013, IRB No.102-051-E |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | |
| 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 study start date | 01/07/2013 |
| Completion date | 18/01/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 2000 |
| Key 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 |
| Key exclusion criteria | 1. Acute coronary syndrome caused by major trauma, GI bleeding, surgery, or endovascular interventions 2. Participating in other clinical trials |
| Date of first enrolment | 01/11/2013 |
| Date of final enrolment | 30/09/2016 |
Locations
Countries of recruitment
- Taiwan
Study participating centres
Zhongshan South Road
Zhongzheng District
Taipei City
100
Taiwan
Section 2
Zhongshan N Rd
Zhongshan District
Taipei City
101
Taiwan
Section 2
Shipai Road
Beitou District
Taipei City
112
Taiwan
Wenchang Road
Shilin District
Taipei City
112
Taiwan
Section 2
Chenggong Road
Neihu District
Taipei City
114
Taiwan
Section 3
Xinglong Road
Wenshan District
Taipei City
116
Taiwan
Zhenxing Street
Beitou District
Taipei City
112
Taiwan
Section 4
Ren'ai Road
Da’an District
Taipei City
106
Taiwan
Section 2
Nanya South Road
Banqiao District
New Taipei City
220
Taiwan
Zhongzheng Road
Zhonghe District
New Taipei City
235
Taiwan
Fuxing Street
Guishan District
Taoyuan City
333
Taiwan
Jianguo Road
Xindian District
New Taipei City
231
Taiwan
Luodong Township
Yilan County
265
Taiwan
Xinmin Road
Yilan City
Yilan County
260
Taiwan
Section 1
Jianguo North Road
South District
Taichung City
402
Taiwan
Yude Road
North District
Taichung City
404
Taiwan
Section 4
Taiwan Boulevard
Xitun District
Taichung City
407
Taiwan
Sec. 2
Yun-Lin Rd.
Douliou City
640
Taiwan
Shatian Road
Shalu District
Taichung City
433
Taiwan
Shengli Road
North District
Tainan City
704
Taiwan
Zhonghua Rd.
Yongkang Dist.
Tainan City
710
Taiwan
Dapi Road
Niaosong District
Kaohsiung City
833
Taiwan
Dazhong 1st Road
Zuoying District
Kaohsiung City
813
Taiwan
Yida Road
Jiaosu Village
Yanchao District
Kaohsiung City
821
Taiwan
Ziyou 1st Road
Sanmin District
Kaohsiung City
807
Taiwan
Lane 442
Section 1
Jingguo Road
North District
Hsinchu City
300
Taiwan
Dalian Road
Pingtung City
900
Taiwan
Sponsor information
Not defined
13F-1, No. 11, Min-Chuan W. Road, Taipei 10452, Taiwan, R.O.C
Taipei
104
Taiwan
| Phone | 886-2-2597-6177 |
|---|---|
| tsoc@tsoc.org.tw | |
| Website | http://www.tsoc.org.tw/ |
"ROR" |
https://ror.org/00j2yyv15 |
Funders
Funder type
Not defined
No information available
Results and Publications
| Intention to publish date | 18/01/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Publication in a high-impact peer-reviewed journal is planned, two years after the overall end of the trial |
| IPD sharing plan |
