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).

Who is this study for? Patients with ST Elevation Myocardial Infarction
What treatments are being studied? Tenecteplase
Status: Recruiting
Location: See all (22) locations...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Adult men and women aged over 18 who present with STEMI within 6 hours of symptom onset. Patients will be eligible if they have symptoms consistent with myocardial ischaemia (chest pain, dyspnoea) for at least 20 minutes accompanied by definite ECGs indicating STEMI as defined by Australian National Heart Foundation (NHF) guidelines

• Willing and able to comply with all study requirements, including treatment, assessment and clinic visit attendances

• Able to personally read and understand the Participant Information and Consent Form and provide written, signed and dated informed consent to participate in the study

• (At time of PCI) Patient has received metallic drug-eluting stent

• Participant consents to have a 3-7 day (discharge) and 6 month follow up cardiac MRI

Locations
Other Locations
Australia
Royal Adelaide Hospital
RECRUITING
Adelaide
Bankstown-Lidcombe Hospital
NOT_YET_RECRUITING
Bankstown
Box Hill Hospital
RECRUITING
Box Hill
Royal Prince Alfred Hospital
RECRUITING
Camperdown
Jessie McPherson Private Hospital
RECRUITING
Clayton
Victorian Heart Hospital
RECRUITING
Clayton
Concord Repatriation General Hospital
RECRUITING
Concord
Lyell McEwin Hospital
RECRUITING
Elizabeth Vale
The Northern Hospital
RECRUITING
Epping
Frankston Hospital
RECRUITING
Frankston
Northern Beaches Hospital
NOT_YET_RECRUITING
Frenchs Forest
Liverpool Hospital
RECRUITING
Liverpool
Fiona Stanley Hospital
NOT_YET_RECRUITING
Murdoch
John Hunter Hospital
RECRUITING
New Lambton Heights
Royal Perth Hospital
RECRUITING
Perth
Prince of Wales Hospital
NOT_YET_RECRUITING
Randwick
Sunshine Hospital
RECRUITING
Saint Albans
Wollongong Hospital
WITHDRAWN
Wollongong
New Zealand
Auckland City Hospital
NOT_YET_RECRUITING
Auckland
Christchurch Hospital
NOT_YET_RECRUITING
Christchurch
Waikato Hospital
RECRUITING
Hamilton
Wellington Hospital
NOT_YET_RECRUITING
Wellington
Contact Information
Primary
Martin Ng, MBBS (Hons)
martin.ng@sydney.edu.au
+614 3407 8507
Backup
Rebecca Mister
RESTORE-MI.Study@sydney.edu.au
+612 9562 5000
Time Frame
Start Date: 2021-10-14
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 445
Treatments
Experimental: Tenecteplase (1/3 systemic weight based dose)
Tenecteplase will be reconstituted in 20mL sterile water for injection at 1/3 of the weight based dose, and administered by intracoronary infusion over 3 minutes.
Placebo_comparator: Sterile Water for injection (WFI)
Water for injection will be prepared to 20mL over an equivalent time period to the reconstitution time of the experimental arm, in order to maintain the blind, and administered by intracoronary infusion over 3 minutes.
Related Therapeutic Areas
Sponsors
Leads: University of Sydney

This content was sourced from clinicaltrials.gov