Intra-coronary administration of tacrolimus prior to primary coronary intervention attenuates infarct size and improves left ventricular function in patients with ST-segment Elevation Myocardial Infarction

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN38455499

Enrollment

1200

Registered

2013-09-11

Start date

2013-09-01

Completion date

Unknown

Last updated

2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute ST segment elevation myocardial infarction Circulatory System Acute myocardial infarction, unspecified

Interventions

Study arm- 600 participants. Intra-coronary transfusion of tacrolimus before primary percutaneous coronary intervention for acute myocardial infarction. Control arm-600 participants. Intra-coronary tr

Eligibility

Sex/Gender

All

Inclusion criteria

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).

Exclusion criteria

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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	—

Countries

China, Taiwan

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 8, 2026