The aim of this trial is to determine over 2 years of follow up in 800 adults with STEMI who have undergone primary PCI and have an IMR score greater than 32 randomly allocated to single, 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 intracoronary low 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.

Supported By:

National Health and Medical Research Council (NHMRC)

Eligibility:

Adult men and women who present with STEMI and have undergone PCI within 12 hours of symptom onset, with an IMR >32.

Registration ID:

ACTRN12618000778280

Participation:

A target population of 1666 participants who present with STEMI within 12 hours of symptom onset. Approximately 50% of participants (~800) are anticipated to meet randomisation criteria, to receive intracoronary TNK or placebo.

Australian Lead Group:

NHMRC CTC

Status:

Open to recruitment (Pilot phase only)

Activation Date:

September 2018

Chairs:

Associate Professor Martin Ng

Contact:

RESTORE-MI@ctc.usyd.edu.au