The aim of this trial is to determine over 2 years of follow up in at least 500 adults with STEMI who have undergone primary PCI and have an IMR score greater than 32 randomly allocated to a single low, or very low dose tenecteplase or placebo treatment.

See ANZCTR for full trial details >

 

Trial Summary:

In patients with ST-Elevated Myocardial Infarction (STEMI), percutaneous coronary intervention (PCI; angioplasty with stenting) restores epicardial coronary blood flow. Yet half of these patients continue to have impaired perfusion on the myocardial level and this portends a poor prognosis. Poor microcirculatory reperfusion has also been shown to be a predictor of death or rehospitalisation for heat failure after three years in post-PCI STEMI patients. The development of the index of microcirculatory resistance (IMR) has allowed easy assessment of the coronary microcirculation.

In this trial, participants who have undergone primary PCI with an IMR score greater than 32 will be randomised to receive a low, or very low intracoronary dose tenecteplase (TNK) or placebo. Participants with an IMR score less than or equal to 32 will be entered into a registry for follow up. The aim of the trial is to evaluate the effects of tenecteplase compared with placebo on acute and long-term clinical outcomes in STEMI patients with high microvascular resistance post-PCI. The primary endpoint will be cardiovascular mortality and rehospitalisation for heart failure at 24 months.

A subset of randomised participants will also undergo cardiac MRIs at discharge and 6 months to evaluate the size of their infarct, and intracoronary bleeding rates.

Supported By:

National Health and Medical Research Council (NHMRC), Abbott Australasia, and Genentech Inc.

Eligibility:

Adult men and women who present with STEMI and have undergone PCI within 6 hours of symptom onset, with an IMR >32.

Registration ID:

ACTRN12618000778280

Participation:

A target population of at least 500 participants who present with STEMI within 6 hours of symptom onset. Approximately 50% of participants (~250) are anticipated to meet randomisation criteria, to receive intracoronary TNK (low or very lose dose) or placebo.

Australian Lead Group:

NHMRC CTC

Status:

Start-up

Activation Date:

April 2021 (anticipated)

Chairs:

Associate Professor Martin Ng

Contact:

RESTORE-MI@ctc.usyd.edu.au