Phase
Condition
Angina
Myocardial Ischemia
Cardiac Ischemia
Treatment
Sterile water for injection (WFI)
Tenecteplase (1/3 systemic weight based dose)
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Adult men and women aged over 18 who present with STEMI within 6 hours of symptomonset. Patients will be eligible if they have symptoms consistent with myocardialischaemia (chest pain, dyspnoea) for at least 20 minutes accompanied by definiteECGs 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 Formand 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
Exclusion
Exclusion Criteria:
At the time of screening and/or prior to randomisation, no known;
Previous coronary bypass grafting
Other residual lesions with ≥50% diameter stenosis in the culprit vessel
Prior myocardial infarction in the target territory
Presence of contraindications to thrombolytic therapy (including history of strokeand recent brain surgery active internal bleeding; history of cerebrovascularaccident; intracranial or intraspinal surgery, or trauma within 2 months;intracranial neoplasm, arteriovenous malformation, or aneurysm; known bleedingdiathesis; and severe uncontrolled hypertension)
Presence of contraindications to adenosine infusion for IMR measurement includingsinus node disease, moderate to severe bronchoconstrictive disease and second orthird-degree atrioventricular (AV) block
Diagnosis of metastatic disease
Concurrent illness, including severe infection that may jeopardise the ability ofthe patient to undergo the procedures outlined in this protocol with reasonablesafety
Serious medical or psychiatric conditions that might limit the ability of thepatient to comply with the protocol
Pregnancy, lactation, or inadequate contraception. Women must be post-menopausal,infertile, or use a reliable means of contraception. Women of childbearing potentialmust have a negative pregnancy test done within 7 days prior to registration. Menmust have been surgically sterilised or use a (double if required) barrier method ofcontraception.
Participation in any investigational study in the previous 30 days Other exclusion criteria:
(Cardiac MRI cohort only) Presence of contraindications to contrast enhanced MRIincluding severe claustrophobia, pregnancy, pacemakers, non-MRI compatible aneurysmclips, defibrillators and estimated glomerular filtration rate of <30mL/min.
(At time of PCI)
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 orother reasons.
Study Design
Study Description
Connect with a study center
Bankstown-Lidcombe Hospital
Bankstown, New South Wales 2200
AustraliaSite Not Available
Royal Prince Alfred Hospital
Camperdown, New South Wales 2050
AustraliaActive - Recruiting
Concord Repatriation General Hospital
Concord, New South Wales 2139
AustraliaActive - Recruiting
Northern Beaches Hospital
Frenchs Forest, New South Wales 2086
AustraliaSite Not Available
Liverpool Hospital
Liverpool, New South Wales 2170
AustraliaActive - Recruiting
John Hunter Hospital
New Lambton Heights, New South Wales 2305
AustraliaActive - Recruiting
Prince of Wales Hospital
Randwick, New South Wales 2031
AustraliaSite Not Available
Wollongong Hospital
Wollongong, New South Wales 2500
AustraliaSite Not Available
Royal Adelaide Hospital
Adelaide, South Australia 5000
AustraliaActive - Recruiting
Lyell McEwin Hospital
Elizabeth Vale, South Australia 5112
AustraliaActive - Recruiting
Box Hill Hospital
Box Hill, Victoria 3128
AustraliaActive - Recruiting
Jessie McPherson Private Hospital
Clayton, Victoria 3168
AustraliaActive - Recruiting
Monash Medical Centre - Clayton
Clayton, Victoria 3168
AustraliaActive - Recruiting
Victorian Heart Hospital
Clayton, Victoria 3168
AustraliaActive - Recruiting
The Northern Hospital
Epping, Victoria 3076
AustraliaActive - Recruiting
Frankston Hospital
Frankston, Victoria 3199
AustraliaActive - Recruiting
Sunshine Hospital
Saint Albans, Victoria 3021
AustraliaActive - Recruiting
Fiona Stanley Hospital
Murdoch, Western Australia 6150
AustraliaSite Not Available
Royal Perth Hospital
Perth, Western Australia 6000
AustraliaActive - Recruiting
Auckland City Hospital
Auckland, 1023
New ZealandSite Not Available
Christchurch Hospital
Christchurch, 4710
New ZealandSite Not Available
Waikato Hospital
Hamilton, 3240
New ZealandActive - Recruiting
Wellington Hospital
Wellington, 2820
New ZealandSite Not Available
Stanford University
Stanford, California 94305
United StatesSite Not Available
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