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RECRUITING
NCT03998319
PHASE3

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

Sponsor: University of Sydney

View on ClinicalTrials.gov

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.

Official title: A Randomised Trial to Evaluate the Efficacy of Low-dose Intracoronary Tenecteplase in ST-Elevation Myocardial Infarction (STEMI) Patients With High Microvascular Resistance Post-percutaneous Coronary Intervention (PCI).

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

445

Start Date

2021-10-14

Completion Date

2026-12-31

Last Updated

2024-09-27

Healthy Volunteers

No

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.

Locations (22)

Bankstown-Lidcombe Hospital

Bankstown, New South Wales, Australia

Royal Prince Alfred Hospital

Camperdown, New South Wales, Australia

Concord Repatriation General Hospital

Concord, New South Wales, Australia

Northern Beaches Hospital

Frenchs Forest, New South Wales, Australia

Liverpool Hospital

Liverpool, New South Wales, Australia

John Hunter Hospital

New Lambton Heights, New South Wales, Australia

Prince of Wales Hospital

Randwick, New South Wales, Australia

Wollongong Hospital

Wollongong, New South Wales, Australia

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Lyell McEwin Hospital

Elizabeth Vale, South Australia, Australia

Box Hill Hospital

Box Hill, Victoria, Australia

Jessie McPherson Private Hospital

Clayton, Victoria, Australia

Victorian Heart Hospital

Clayton, Victoria, Australia

The Northern Hospital

Epping, Victoria, Australia

Frankston Hospital

Frankston, Victoria, Australia

Sunshine Hospital

Saint Albans, Victoria, Australia

Fiona Stanley Hospital

Murdoch, Western Australia, Australia

Royal Perth Hospital

Perth, Western Australia, Australia

Auckland City Hospital

Auckland, New Zealand

Christchurch Hospital

Christchurch, New Zealand

Waikato Hospital

Hamilton, New Zealand

Wellington Hospital

Wellington, New Zealand