A Study of Low-dose Intracoronary Thrombolytic Therapy in STEMI (Heart Attack) Patients.
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Sydney
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 within 2 months; intracranial neoplasm, arteriovenous malformation, or aneurysm; known bleeding diathesis; and severe uncontrolled hypertension)
Trial design
Design model
Parallel
Treatments tested in this trial
Tenecteplase (1/3 systemic weight based dose)
Drug50mg reconstituted to 20mL for intracoronary infusion at 1/3 weight based dose.
Sterile water for injection (WFI)
Other interventionPlacebo comparative arm.
Treatment groups
445 Participants
are divided into 2 treatment groupsGroup A: Tenecteplase (1/3 systemic weight based dose)Experimental treatment 1 intervention
Group B: Sterile Water for injection (WFI)Placebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
To compare the number of participants who experience cardiovascular mortality and rehospitalisation for heart failure at 24 months in those given tenecteplase with those given placebo (Cardiac MRI cohort only)
Cardiovascular mortality and rehospitalisation for heart failure assessed by medical record review.
Time frame
24 months2
To compare MI size as a % of LV mass and intramyocardial bleeding rates in participants at 6 months post PCI in those given low dose tenecteplase with those given placebo.
MI size and intramyocardial bleeding rates will be assessed upon cardiac MRI at discharge (3-7 days post procedure) as a baseline measure, and at 6 months post-PCI.
Time frame
6 months after primary PCI procedure.Secondary outcomes
1
Number of participants who experience individual components of the primary endpoint: (a) cardiovascular mortality at 24 months, (b) rehospitalisation for heart failure at 24 months;
Cardiovascular mortality and rehospitalisation for heart failure assessed by medical record review, respectively.
Time frame
24 months after primary PCI procedure2
Number of Major Adverse Cardiac Events (MACE)
Major Adverse Coronary Events (these are combination events involving cardiovascular death, non-fatal MI, non-fatal stroke and unstable angina) assessed from physical assessment and medical record review
Time frame
24 months after primary PCI procedure3
All-cause mortality
All-cause mortality assessed by physical assessment and medical record review.
Time frame
24 months after primary PCI procedure4
Number of stroke events
Stroke events will be assessed by medical record review. Assessment will cover all aspects of the stroke event (including type, severity, frequency).
Time frame
24 months after primary PCI procedureOther outcomes
1
DNA analyses (Subject to funding)
Samples of whole blood will be used for DNA analyses at baseline, post-PCI, discharge and 6 month follow up (6m follow up for Randomised participants only).
Time frame
0-6 months2
MicroRNA analyses (Subject to funding)
Samples of whole blood will be used for microRNA analyses at baseline, post-PCI, discharge and 6 month follow up (6m follow up for Randomised participants only).
Time frame
0-6 months3
Vasoactive markers (Subject to funding)
Samples of whole blood will be used for vasoactive marker analyses at baseline, post-PCI, discharge and 6 month follow up (6m follow up for Randomised participants only).
Time frame
0-6 months4
Inflammatory markers (Subject to funding)
Samples of whole blood will be used for inflammatory marker analyses at baseline, post-PCI, discharge and 6 month follow up (6m follow up for Randomised participants only).
Time frame
0-6 monthsSponsors and contacts
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Source ClinicalTrials.gov