A Study of Low-dose Intracoronary Thrombolytic Therapy in STEMI (Heart Attack) Patients.

Summary

Heart attacks are caused by a blood clot blocking the blood vessels of the heart, preventing blood getting to the heart muscle. Opening up the artery with a balloon (angioplasty) and a small mesh tube (stent) although life saving can cause this clot to break up and get washed downstream, which can make the heart attack worse. The investigators can measure the amount of damage caused to the microcirculation by calculating the IMR (Index of Microcirculatory resistance).

This can be measured by a wire in the coronary artery with a pressure sensor at the tip. If the IMR is elevated, it is suggestive of extensive microcirculatory damage. A clot dissolving medicine can be administered in the artery to try and reduce the IMR which can reduce damage to the heart muscle and improve outcomes.

Impaired microcirculatory perfusion in patients as a result of ST-elevation myocardial infarction (STEMI) is associated with poor clinical outcomes. This project seeks to identify patients with impaired microcirculatory perfusion after STEMI and to assess whether acute improvement in microcirculatory perfusion in these patients by the use of intracoronary thrombolytic therapy results in improved clinical outcomes.

Conditions

• STEMI
• Elevated IMR (>32)

Interventions

DRUG

Tenecteplase (1/3 systemic weight based dose)

50mg reconstituted to 20mL for intracoronary infusion at 1/3 weight based dose.

OTHER

Sterile water for injection (WFI)

Placebo comparative arm.

Sponsors & Collaborators

• University of Sydney

  lead OTHER

Principal Investigators

• Martin Ng, MBBS (Hons) · Royal Prince Alfred Hospital, Sydney, Australia

• Andy Yong, MBBS · Concord Repatriation General Hospital

• Anthony Keech, MBBS · National Health and Medical Research Council, Australia

• William Fearon, MD · Stanford University

• Jamie Layland, MBBS · Peninsula Health

• Harvey White, FRCS · Green Lane Cardiovascular Service

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-10-14

Primary Completion

2024-12-31

Completion

2026-12-31

FDA Drug

Yes

Countries

• Australia
• New Zealand

Study Locations