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New treatment option for STEMI
Official title A Study of Low-dose Intracoronary Thrombolytic Therapy in STEMI (Heart Attack) Patients.
ClinicalTrials.gov ID: NCT03998319
What this study is testing
What is Tenecteplase (1/3 systemic weight based dose)?
Tenecteplase (1/3 systemic weight based dose) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for stemi.
Also referred to as TNKase.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
- (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
You likely can't join if
- 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 stroke and recent brain surgery active internal bleeding; history of...
- Presence of contraindications to adenosine infusion for IMR measurement including sinus node disease, moderate to severe bronchoconstrictive disease...
See the full eligibility criteria
- 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...
- 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
- 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 stroke and recent brain surgery active internal bleeding; history of cerebrovascular accident; intracranial or intraspinal surgery, or trauma...
- Presence of contraindications to adenosine infusion for IMR measurement including sinus node disease, moderate to severe bronchoconstrictive disease and second or third-degree atrioventricular (AV) block
- Diagnosis of metastatic disease
- Concurrent illness, including severe infection that may jeopardise the ability of the patient to undergo the procedures outlined in this protocol with reasonable safety
- Serious medical or psychiatric conditions that might limit the ability of the patient 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 potential must have a negative pregnancy test done within 7...
- Participation in any investigational study in the previous 30 days Other exclusion criteria:
- (Cardiac MRI cohort only) Presence of contraindications to contrast enhanced MRI including severe claustrophobia, pregnancy, pacemakers, non-MRI compatible aneurysm clips, defibrillators and estimated glomerular...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Bankstown, New South Wales, Australia
- Camperdown, New South Wales, Australia
- Concord, New South Wales, Australia
- Frenchs Forest, New South Wales, Australia
- Liverpool, New South Wales, Australia
- New Lambton Heights, New South Wales, Australia
- Randwick, New South Wales, Australia
- Wollongong, New South Wales, Australia
- Adelaide, South Australia, Australia
- Elizabeth Vale, South Australia, Australia
- Box Hill, Victoria, Australia
- Clayton, Victoria, Australia
- Epping, Victoria, Australia
- Frankston, Victoria, Australia
- Saint Albans, Victoria, Australia
- Murdoch, Western Australia, Australia
- Perth, Western Australia, Australia
- Auckland, New Zealand
- Christchurch, New Zealand
- Hamilton, New Zealand
+ 1 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bankstown, New South Wales, Australia; Camperdown, New South Wales, Australia; Concord, New South Wales, Australia; Frenchs Forest, New South Wales, Australia; Liverpool, New South Wales, Australia; New Lambton Heights, New South Wales, Australia and 15 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.