Condition category
Circulatory System
Date applied
19/08/2013
Date assigned
11/09/2013
Last edited
08/04/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Studies have previously shown that cyclosporine therapy effectively reduced left ventricular infarction size and preserved left ventricular function after acute myocardial infarction (heart attack). In view of the fact that immune and inflammatory reactions are one of the major contributors to death of the cells that make up the cardiac muscle (cardiomyocytes) after acute myocardial infarction and that the drug tacrolimus is more effective than cyclosporine, we think that tacrolimus may limit the extent of myocardial infarction and improve left ventricular function after heart attack. To test this idea, animal studies were conducted which showed promising results, raising the need for a study to investigate the impact of tacrolimus when given as an injection directly into the heart on improving reperfusion rate, left ventricular function and clinical outcome in patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention.

Who can participate?
Men and women, aged between 20 and 80 years old, with acute ST-segment elevation myocardial infarction occurring within 12 hours and receiving primary percutaneous coronary intervention (PCI).

What does the study involve?
The participants are randomly allocated to one of the two groups. In the study group, tacrolimus is injected directly into the heart before primary PCI. In the control group, normal saline is injected directly into the heart before primary PCI.

What are the possible benefits and risks of participating?
The possible benefits are improvement of heart function and reduction of adverse outcomes. Possible risks include reduced kidney function, neurotoxicity (affecting brain cells), hyperglycemia (increased blood sugar level) and diarrhoea.

Where is the study run from?
Six medical centres located in China and Taiwan.

When is the study starting and how long is it expected to run for?
The study started in September 2013 and it is expected to run for 4 years. The trial will be recruiting participants for 3 years, and all patients will be followed up at least 1 year.

Who is funding the study?
Chang Gung Memorial Hospital (Taiwan).

Who is the main contact?
Dr Hon-Kan Yip

Trial website

Contact information

Type

Scientific

Primary contact

Dr Hon-Kan Yip

ORCID ID

Contact details

123
Ta Pei Road
Niao Sung District
Kaohsiung
833
Taiwan

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Intra-COronary Administration of Tacrolimus prior to first-balloon attenuates infarct size and improves left ventricular function in patients with ST-segment Elevation Myocardial Infarction (COAT-STEMI) undergoing primary coronary intervention: a double-blind, placebo-controlled, randomized, multi-center clinical trial

Acronym

Study hypothesis

Tacrolimus may limit the extent of myocardial infarction and improve left ventricular function in the setting of acute myocardial infarction.

Ethics approval

Chang Gung Memorial Hospital, 29/07/2013, ref: 102-1228A3

Study design

Prospective randomized double blind placebo controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet: Hon-Kan Yip/ Chang Gung Memorial Hospital. E-mail: han.gung@msa.hinet.net

Condition

Acute ST segment elevation myocardial infarction

Intervention

Study arm- 600 participants. Intra-coronary transfusion of tacrolimus before primary percutaneous coronary intervention for acute myocardial infarction.
Control arm-600 participants. Intra-coronary transfusion of normal saline before primary percutaneous coronary intervention acute myocardial infarction.
The primary percutaneous coronary intervention procedures are the same in both arms and following the clinical practice. The duration of treatment is the same as the procedure of primary percutaneous coronary intervention. All patients will be followed up at least one year.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Percentage of Thrombolysis In Myocardial Infarction (TIMI)-3 flow post primary percutaneous coronary intervention after the procedure by coronary angiography (the same day).

Secondary outcome measures

1. 30 days mortality
2. One year cardiac mortality
3. One year adverse outcome (including mortality, reinfarction and target vessel revascularization)
4. One year re-hospitalization due to congestive heart failure
5. 6 months improvement of left ventricular function by echocardiography

Overall trial start date

01/09/2013

Overall trial end date

31/08/2016

Reason abandoned

Eligibility

Participant inclusion criteria

Male and female, age between 20 and 80 years old with acute ST segment elevation myocardial infarction occuring less than 12 hours and receiving primary percutaneous coronary intervention (PCI).

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

1200

Participant exclusion criteria

1. Recent myocardial infarction and stroke within 3 months
2. Receiving immunosupressant, adverse drug reaction for immunosuppressant, cardiogenic shock, active inflammative or infectious disease
3. Pregnant or breast feeding women
4. Liver cirrhosis
5. Hemodialysis patients
6. Patients receiving organ transplant
7. Malignancy
8. Life span less than 1 year

Recruitment start date

01/09/2013

Recruitment end date

31/08/2016

Locations

Countries of recruitment

China, Taiwan

Trial participating centre

Kaohsiung Chang Gung Memorial Hospital
No.123, DAPI Road Niaosng District
Kaohsiung City
83301
Taiwan

Trial participating centre

Pingtung Christian Hospital
No. 60, Dalian Rdoad
Pingtung City
90
Taiwan

Trial participating centre

Kaohsiung University Chung-ho Memorial Hospital
No. 100, Ziyou 1st Road Sanmin District
Kaohsiung City
807
Taiwan

Trial participating centre

Kaohsiung Veterans General Hospital
No. 386, Dazhong 1st Road Zuoying District
Kaohsiung City
813
Taiwan

Trial participating centre

Chi Mei Hospital
No.201, Taikang Taikang Vil. Liuying District
Tainan City
376
Taiwan

Trial participating centre

Xiamen Cardiovascular Hospital
Medical College of Xiamen University
Xiamen
-
China

Sponsor information

Organisation

Chang Gung Memorial Hospital (Taiwan)

Sponsor details

123
Ta Pei Road
Niao Sung District
Kaohsiung
833
Taiwan

Sponsor type

Hospital/treatment centre

Website

http://www.cgmh.org.tw

Funders

Funder type

Hospital/treatment centre

Funder name

Chang Gung Memorial Hospital (Taiwan)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

08/04/2016: Five additional trial participating centres have been added.