Actively Recruiting
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)
Led by University of Sydney · Updated on 2024-09-27
445
Participants Needed
22
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Heart attacks occur when a blood clot blocks the heart's blood vessels, stopping blood flow to the heart muscle. This trial focuses on patients with ST-elevation myocardial infarction (STEMI) and looks at how microcirculatory damage can be measured using the Index of Microcirculatory Resistance (IMR). The study aims to find out if treating patients with impaired microcirculatory perfusion using low-dose intracoronary thrombolytic therapy can reduce heart muscle damage and improve clinical outcomes. Participants who have had a heart attack and undergone angioplasty will have their IMR measured. Those with an IMR above 32 will be randomly assigned to receive either low-dose tenecteplase (a clot-dissolving drug) or a placebo (sterile water) administered directly into the coronary artery. Patients with lower IMR will be followed in a registry. The treatment is given as an intracoronary infusion over 3 minutes. Cardiac enzymes, MRI scans, and other heart function tests will be done at various time points. During the study, participants will have heart enzyme tests at hospital admission and discharge. Those in the randomised group will receive cardiac MRI scans at discharge and six months later. Follow-up visits will occur at 30 days, then 6, 12, and 24 months after discharge to monitor heart function, rehospitalisation, and mortality. The main outcomes measured include cardiovascular death, heart failure rehospitalisation, heart attack size, and bleeding events, with safety and efficacy monitored closely throughout the study period.
CONDITIONS
Brief Title
A Study of Low-dose Intracoronary Thrombolytic Therapy in STEMI (Heart Attack) Patients.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult men and women aged over 18 who present with STEMI within 6 hours of symptom onset
- Symptoms consistent with myocardial ischaemia for at least 20 minutes with ECG indicating STEMI
- Willing and able to comply with all study requirements including treatment and clinic visits
- Able to read, understand, and provide written informed consent
- Received metallic drug-eluting stent at the time of PCI
- Consent to have cardiac MRI at 3-7 days (discharge) and 6 months follow-up
You will not qualify if you...
- Previous coronary bypass grafting
- Other residual lesions with 50% or greater diameter stenosis in the culprit vessel
- Prior myocardial infarction in the target territory
- Contraindications to thrombolytic therapy such as history of stroke, recent brain surgery, active internal bleeding, cerebrovascular accident, intracranial or spinal surgery or trauma within 2 months, intracranial neoplasm, bleeding disorders, or severe uncontrolled hypertension
- Contraindications to adenosine infusion including sinus node disease, moderate to severe bronchoconstrictive disease, second or third-degree AV block
- Diagnosis of metastatic disease
- Severe concurrent illness or infection that may limit safe participation
- Serious medical or psychiatric conditions limiting protocol compliance
- Pregnancy, lactation, or inadequate contraception; women of childbearing potential must have negative pregnancy test within 7 days prior to registration; men must use reliable contraception
- Participation in any investigational study within the previous 30 days
- For cardiac MRI cohort: contraindications to MRI including severe claustrophobia, pacemakers, non-MRI compatible devices, or low kidney function
- Patients who received GpIIb/IIIa treatment prior to IMR measurement
- Patients who do not undergo primary PCI due to lack of severity of culprit lesion or other reasons
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 6 hours from symptom onset to PCI
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person during hospital admission)
Duration - Single administration during PCI procedure
Participants with high microvascular resistance receive low-dose intracoronary tenecteplase or placebo immediately after PCI.
1 treatment visit (in-person during PCI)
Duration - Up to 6 months
Participants have cardiac enzyme measurements at baseline and discharge, and cardiac MRI at discharge (3-7 days post PCI) and 6 months post PCI.
3 visits (baseline, discharge, and 6 months post PCI)
Duration - 24 months after discharge
All participants are followed up to monitor health outcomes including cardiovascular events and rehospitalisation.
Follow-up visits at 30 days, 6 months, 12 months, and 24 months post discharge
Trial Site Locations
Total: 22 locations
1
Bankstown-Lidcombe Hospital
Bankstown, New South Wales, Australia, 2200
Not Yet Recruiting
2
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia, 2050
Actively Recruiting
3
Concord Repatriation General Hospital
Concord, New South Wales, Australia, 2139
Actively Recruiting
4
Northern Beaches Hospital
Frenchs Forest, New South Wales, Australia, 2086
Not Yet Recruiting
5
Liverpool Hospital
Liverpool, New South Wales, Australia, 2170
Actively Recruiting
6
John Hunter Hospital
New Lambton Heights, New South Wales, Australia, 2305
Actively Recruiting
7
Prince of Wales Hospital
Randwick, New South Wales, Australia, 2031
Not Yet Recruiting
8
Wollongong Hospital
Wollongong, New South Wales, Australia, 2500
Withdrawn
9
Royal Adelaide Hospital
Adelaide, South Australia, Australia, 5000
Actively Recruiting
10
Lyell McEwin Hospital
Elizabeth Vale, South Australia, Australia, 5112
Actively Recruiting
11
Box Hill Hospital
Box Hill, Victoria, Australia, 3128
Actively Recruiting
12
Jessie McPherson Private Hospital
Clayton, Victoria, Australia, 3168
Actively Recruiting
13
Victorian Heart Hospital
Clayton, Victoria, Australia, 3168
Actively Recruiting
14
The Northern Hospital
Epping, Victoria, Australia, 3076
Actively Recruiting
15
Frankston Hospital
Frankston, Victoria, Australia, 3199
Actively Recruiting
16
Sunshine Hospital
Saint Albans, Victoria, Australia, 3021
Actively Recruiting
17
Fiona Stanley Hospital
Murdoch, Western Australia, Australia, 6150
Not Yet Recruiting
18
Royal Perth Hospital
Perth, Western Australia, Australia, 6000
Actively Recruiting
19
Auckland City Hospital
Auckland, New Zealand, 1023
Not Yet Recruiting
20
Christchurch Hospital
Christchurch, New Zealand, 4710
Not Yet Recruiting
21
Waikato Hospital
Hamilton, New Zealand, 3240
Actively Recruiting
22
Wellington Hospital
Wellington, New Zealand, 2820
Not Yet Recruiting
Research Team
M
Martin Ng, MBBS (Hons)
R
Rebecca Mister
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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