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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03998319




Registration number
NCT03998319
Ethics application status
Date submitted
6/05/2019
Date registered
26/06/2019

Titles & IDs
Public title
A Study of Low-dose Intracoronary Thrombolytic Therapy in STEMI (Heart Attack) Patients.
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).
Secondary ID [1] 0 0
CTC0150
Universal Trial Number (UTN)
Trial acronym
RESTORE-MI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
STEMI 0 0
Elevated IMR (>32) 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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)
Timepoint [1] 0 0
24 months
Primary outcome [2] 0 0
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.
Timepoint [2] 0 0
6 months after primary PCI procedure.
Secondary outcome [1] 0 0
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;
Timepoint [1] 0 0
24 months after primary PCI procedure
Secondary outcome [2] 0 0
Number of Major Adverse Cardiac Events (MACE)
Timepoint [2] 0 0
24 months after primary PCI procedure
Secondary outcome [3] 0 0
All-cause mortality
Timepoint [3] 0 0
24 months after primary PCI procedure
Secondary outcome [4] 0 0
Number of stroke events
Timepoint [4] 0 0
24 months after primary PCI procedure
Secondary outcome [5] 0 0
Number of incidences of bailout treatment use for no-reflow syndrome
Timepoint [5] 0 0
24 months after primary PCI procedure
Secondary outcome [6] 0 0
Occurrence of major (Type 3 or greater) and minor (Type 2) bleeding as defined by the Bleeding Academic Research Consortium
Timepoint [6] 0 0
24 months after primary PCI procedure
Secondary outcome [7] 0 0
Index of Microcirculatory Resistance (IMR)
Timepoint [7] 0 0
0-2 hours
Secondary outcome [8] 0 0
Fractional Flow Reserve (FFR)
Timepoint [8] 0 0
0-2 hours
Secondary outcome [9] 0 0
Coronary Flow Reserve (CFR)
Timepoint [9] 0 0
0-2 hours
Secondary outcome [10] 0 0
Wall Motion Score
Timepoint [10] 0 0
0-6 months
Secondary outcome [11] 0 0
Left ventricular ejection fraction (LVEF)
Timepoint [11] 0 0
0-6 months
Secondary outcome [12] 0 0
Myocardial Blush Grade
Timepoint [12] 0 0
0-2 hours
Secondary outcome [13] 0 0
TIMI Myocardial Perfusion Grade
Timepoint [13] 0 0
0-2 hours
Secondary outcome [14] 0 0
TIMI corrected frame count
Timepoint [14] 0 0
0-2 hours
Secondary outcome [15] 0 0
Cardiac enzyme measurements
Timepoint [15] 0 0
0-32 hours

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/10/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2026
Actual
Sample size
Target
445
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
Bankstown-Lidcombe Hospital - Bankstown
Recruitment hospital [2] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [3] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [4] 0 0
Northern Beaches Hospital - Frenchs Forest
Recruitment hospital [5] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [6] 0 0
John Hunter Hospital - New Lambton Heights
Recruitment hospital [7] 0 0
Prince of Wales Hospital - Randwick
Recruitment hospital [8] 0 0
Wollongong Hospital - Wollongong
Recruitment hospital [9] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [10] 0 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment hospital [11] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [12] 0 0
Jessie McPherson Private Hospital - Clayton
Recruitment hospital [13] 0 0
Monash Medical Centre - Clayton - Clayton
Recruitment hospital [14] 0 0
The Northern Hospital - Epping
Recruitment hospital [15] 0 0
Frankston Hospital - Frankston
Recruitment hospital [16] 0 0
Sunshine Hospital - Saint Albans
Recruitment hospital [17] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [18] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
2200 - Bankstown
Recruitment postcode(s) [2] 0 0
2050 - Camperdown
Recruitment postcode(s) [3] 0 0
2139 - Concord
Recruitment postcode(s) [4] 0 0
2086 - Frenchs Forest
Recruitment postcode(s) [5] 0 0
2170 - Liverpool
Recruitment postcode(s) [6] 0 0
2305 - New Lambton Heights
Recruitment postcode(s) [7] 0 0
2031 - Randwick
Recruitment postcode(s) [8] 0 0
2500 - Wollongong
Recruitment postcode(s) [9] 0 0
5000 - Adelaide
Recruitment postcode(s) [10] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [11] 0 0
3128 - Box Hill
Recruitment postcode(s) [12] 0 0
3168 - Clayton
Recruitment postcode(s) [13] 0 0
3076 - Epping
Recruitment postcode(s) [14] 0 0
3199 - Frankston
Recruitment postcode(s) [15] 0 0
3021 - Saint Albans
Recruitment postcode(s) [16] 0 0
6150 - Murdoch
Recruitment postcode(s) [17] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
New Zealand
State/province [2] 0 0
Christchurch
Country [3] 0 0
New Zealand
State/province [3] 0 0
Hamilton
Country [4] 0 0
New Zealand
State/province [4] 0 0
Wellington

Funding & Sponsors
Primary sponsor type
Other
Name
University of Sydney
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Martin Ng, MBBS (Hons)
Address 0 0
Royal Prince Alfred Hospital, Sydney, Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Martin Ng, MBBS (Hons)
Address 0 0
Country 0 0
Phone 0 0
+614 3407 8507
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Please refer to the NHMRC Clinical Trials Centre publication and data sharing Standard Operating Procedure.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03998319