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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03998319
Registration number
NCT03998319
Ethics application status
Date submitted
6/05/2019
Date registered
26/06/2019
Date last updated
30/10/2023
Titles & IDs
Public title
A Study of Low-dose Intracoronary Thrombolytic Therapy in STEMI (Heart Attack) Patients.
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Scientific title
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).
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Secondary ID [1]
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CTC0150
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Universal Trial Number (UTN)
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Trial acronym
RESTORE-MI
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
STEMI
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Elevated IMR (>32)
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Condition category
Condition code
Cardiovascular
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Coronary heart disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Tenecteplase (1/3 systemic weight based dose)
Other interventions - Sterile water for injection (WFI)
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.
Treatment: Drugs: Tenecteplase (1/3 systemic weight based dose)
50mg reconstituted to 20mL for intracoronary infusion at 1/3 weight based dose.
Other interventions: Sterile water for injection (WFI)
Placebo comparative arm.
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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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)
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Assessment method [1]
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Cardiovascular mortality and rehospitalisation for heart failure assessed by medical record review.
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Timepoint [1]
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24 months
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Primary outcome [2]
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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.
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Assessment method [2]
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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.
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Timepoint [2]
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6 months after primary PCI procedure.
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Secondary outcome [1]
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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;
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Assessment method [1]
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Cardiovascular mortality and rehospitalisation for heart failure assessed by medical record review, respectively.
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Timepoint [1]
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24 months after primary PCI procedure
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Secondary outcome [2]
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Number of Major Adverse Cardiac Events (MACE)
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Assessment method [2]
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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
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Timepoint [2]
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24 months after primary PCI procedure
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Secondary outcome [3]
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All-cause mortality
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Assessment method [3]
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All-cause mortality assessed by physical assessment and medical record review.
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Timepoint [3]
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24 months after primary PCI procedure
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Secondary outcome [4]
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Number of stroke events
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Assessment method [4]
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Stroke events will be assessed by medical record review. Assessment will cover all aspects of the stroke event (including type, severity, frequency).
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Timepoint [4]
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24 months after primary PCI procedure
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Secondary outcome [5]
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Number of incidences of bailout treatment use for no-reflow syndrome
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Assessment method [5]
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Use of Bailout treatment for no-reflow syndrome assessed by medical record review
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Timepoint [5]
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24 months after primary PCI procedure
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Secondary outcome [6]
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Occurrence of major (Type 3 or greater) and minor (Type 2) bleeding as defined by the Bleeding Academic Research Consortium
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Assessment method [6]
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Major (Type 3 or greater) and minor (Type 2) bleeding as defined by the Bleeding Academic Research Consortium. Assessed by medical record review.
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Timepoint [6]
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24 months after primary PCI procedure
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Secondary outcome [7]
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Index of Microcirculatory Resistance (IMR)
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Assessment method [7]
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Index of microcirculatory resistance (IMR) measurement assessed by coronary pressure wire data output review.
This is a simple unit scale, with a higher number indicating a worse outcome with a score of more than 25 indicating abnormal microcirculatory function in the heart.
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Timepoint [7]
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0-2 hours
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Secondary outcome [8]
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Fractional Flow Reserve (FFR)
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Assessment method [8]
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Fractional Flow Reserve measurement assessed by coronary pressure wire data output review prior to randomisation and immediately after primary PCI
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Timepoint [8]
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0-2 hours
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Secondary outcome [9]
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Coronary Flow Reserve (CFR)
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Assessment method [9]
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Coronary Flow Reserve measurement assessed by coronary pressure wire data output review, prior to randomisation and immediately after primary PCI.
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Timepoint [9]
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0-2 hours
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Secondary outcome [10]
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Wall Motion Score
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Assessment method [10]
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The score is measured by simple unit scale (1 = normal, 2 = hypokinetic (muscle impaired), 3= akinetic (muscle dead)). Each of the 16 segments of the hearts is scored, with the total being divided by 16 to derive the score.
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Timepoint [10]
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0-6 months
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Secondary outcome [11]
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Left ventricular ejection fraction (LVEF)
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Assessment method [11]
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Left ventricular ejection fraction measurement from echocardiogram will be used to assess cardiac function prior to randomisation, 48 hours and 6 months post primary PCI
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Timepoint [11]
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0-6 months
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Secondary outcome [12]
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Myocardial Blush Grade
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Assessment method [12]
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Myocardial Blush Grade measurement from angiogram will be used to assess cardiac function. The score goes from 0 to 3, with 3 being normal and 0 being absence of myocardial blush
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Timepoint [12]
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0-2 hours
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Secondary outcome [13]
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TIMI Myocardial Perfusion Grade
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Assessment method [13]
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Thrombolysis in myocardial infarction score from angiogram will be used to assess myocardial perfusion. This score goes from 0 to 3, 3 indicates normal flow within the artery and 0 indicates a complete coronary occlusion.
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Timepoint [13]
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0-2 hours
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Secondary outcome [14]
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TIMI corrected frame count
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Assessment method [14]
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Thrombolysis in myocardial infarction score with corrected frame count from angiogram to assess myocardial perfusion
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Timepoint [14]
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0-2 hours
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Secondary outcome [15]
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Cardiac enzyme measurements
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Assessment method [15]
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Cardiac enzyme levels including troponin T, creatine kinase, creatine kinase-MB and high sensitivity troponin T, from blood samples collected during the hospitalisation period (prior to primary PCI and at 8, 16, 24 and 32 hours post primary PCI).
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Timepoint [15]
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0-32 hours
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Eligibility
Key inclusion criteria
1. 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
2. Willing and able to comply with all study requirements, including treatment,
assessment and clinic visit attendances
3. 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
4. (At time of PCI) Patient has received metallic drug-eluting stent
5. Participant consents to have a 3-7 day (discharge) and 5 month follow up cardiac MRI
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
At the time of screening and/or prior to randomisation, no known;
1. Previous coronary bypass grafting
2. Other residual lesions with =50% diameter stenosis in the culprit vessel
3. Prior myocardial infarction in the target territory
4. 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)
5. 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
6. Diagnosis of metastatic disease
7. Concurrent illness, including severe infection that may jeopardise the ability of the
patient to undergo the procedures outlined in this protocol with reasonable safety
8. Serious medical or psychiatric conditions that might limit the ability of the patient
to comply with the protocol
9. 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 days prior to registration. Men must
have been surgically sterilised or use a (double if required) barrier method of
contraception.
10. Participation in any investigational study in the previous 30 days
Other exclusion criteria:
11. (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 filtration rate of <30mL/min.
(At time of PCI)
12. Patients who received GpIIb/IIIa treatment prior to IMR measurement
13. Patients who do not undergo primary PCI due to lack of severity of culprit lesion or
other reasons.
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Study design
Purpose of the study
Other
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
14/10/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/12/2026
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Actual
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Sample size
Target
445
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
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Recruitment hospital [1]
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Bankstown-Lidcombe Hospital - Bankstown
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Recruitment hospital [2]
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Royal Prince Alfred Hospital - Camperdown
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Recruitment hospital [3]
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Concord Repatriation General Hospital - Concord
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Recruitment hospital [4]
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Northern Beaches Hospital - Frenchs Forest
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Recruitment hospital [5]
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Liverpool Hospital - Liverpool
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Recruitment hospital [6]
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John Hunter Hospital - New Lambton Heights
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Recruitment hospital [7]
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Prince of Wales Hospital - Randwick
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Recruitment hospital [8]
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Wollongong Hospital - Wollongong
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Recruitment hospital [9]
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Royal Adelaide Hospital - Adelaide
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Recruitment hospital [10]
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Lyell McEwin Hospital - Elizabeth Vale
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Recruitment hospital [11]
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Box Hill Hospital - Box Hill
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Recruitment hospital [12]
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Jessie McPherson Private Hospital - Clayton
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Recruitment hospital [13]
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Monash Medical Centre - Clayton - Clayton
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Recruitment hospital [14]
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The Northern Hospital - Epping
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Recruitment hospital [15]
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Frankston Hospital - Frankston
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Recruitment hospital [16]
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Sunshine Hospital - Saint Albans
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Recruitment hospital [17]
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Fiona Stanley Hospital - Murdoch
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Recruitment hospital [18]
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Royal Perth Hospital - Perth
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Recruitment postcode(s) [1]
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2200 - Bankstown
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Recruitment postcode(s) [2]
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2050 - Camperdown
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Recruitment postcode(s) [3]
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2139 - Concord
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Recruitment postcode(s) [4]
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2086 - Frenchs Forest
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Recruitment postcode(s) [5]
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2170 - Liverpool
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Recruitment postcode(s) [6]
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2305 - New Lambton Heights
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Recruitment postcode(s) [7]
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2031 - Randwick
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Recruitment postcode(s) [8]
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2500 - Wollongong
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Recruitment postcode(s) [9]
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5000 - Adelaide
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Recruitment postcode(s) [10]
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5112 - Elizabeth Vale
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Recruitment postcode(s) [11]
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3128 - Box Hill
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Recruitment postcode(s) [12]
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3168 - Clayton
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Recruitment postcode(s) [13]
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3076 - Epping
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Recruitment postcode(s) [14]
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3199 - Frankston
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Recruitment postcode(s) [15]
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3021 - Saint Albans
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Recruitment postcode(s) [16]
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6150 - Murdoch
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Recruitment postcode(s) [17]
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6000 - Perth
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Auckland
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Country [2]
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New Zealand
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State/province [2]
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Christchurch
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Country [3]
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New Zealand
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State/province [3]
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Hamilton
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Country [4]
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New Zealand
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State/province [4]
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Wellington
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Funding & Sponsors
Primary sponsor type
Other
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Name
University of Sydney
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief 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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03998319
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Martin Ng, MBBS (Hons)
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Address
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Royal Prince Alfred Hospital, Sydney, Australia
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Martin Ng, MBBS (Hons)
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Address
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Country
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Phone
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+614 3407 8507
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03998319
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