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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04610892




Registration number
NCT04610892
Ethics application status
Date submitted
28/07/2020
Date registered
2/11/2020

Titles & IDs
Public title
Efficacy and Safety of MEDI6570 in Patients With a History of Myocardial Infarction
Scientific title
A Phase IIB, Randomized, Double Blinded, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of MEDI6570 in Participants With a Prior Myocardial Infarction and Persistent Inflammation
Secondary ID [1] 0 0
2020-000840-75
Secondary ID [2] 0 0
D4920C00002
Universal Trial Number (UTN)
Trial acronym
GOLDILOX
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary Heart Disease (CHD) 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - MEDI6570
Treatment: Other - Placebo

Experimental: MEDI6570 Low dose - Monthly Subcutaneous administration.

Experimental: MEDI6570 Medium dose - Monthly Subcutaneous administration.

Experimental: MEDI6570 High dose - Monthly Subcutaneous administration.

Placebo comparator: Placebo Low dose - Monthly Subcutaneous administration.

Placebo comparator: Placebo Medium dose - Monthly Subcutaneous administration

Placebo comparator: Placebo High dose - Monthly Subcutaneous administration


Treatment: Other: MEDI6570
MEDI6570

Treatment: Other: Placebo
Buffer
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Non Calcified Plaque Volume
Timepoint [1] 0 0
9 months
Secondary outcome [1] 0 0
NT proBNP
Timepoint [1] 0 0
9 months
Secondary outcome [2] 0 0
LVEF
Timepoint [2] 0 0
9 months
Secondary outcome [3] 0 0
Global Longitudinal Strain (GLS)
Timepoint [3] 0 0
9 months
Secondary outcome [4] 0 0
Global non-calcified plaque volume
Timepoint [4] 0 0
9 months
Secondary outcome [5] 0 0
Low attenuation plaque volume
Timepoint [5] 0 0
9 months
Secondary outcome [6] 0 0
Adverse Events as a measure of safety and tolerability of MEDI6570
Timepoint [6] 0 0
13.5 months
Secondary outcome [7] 0 0
Adverse events as a measure of safety and tolerability of MEDI6570
Timepoint [7] 0 0
13.5 months
Secondary outcome [8] 0 0
Incidence Rate of Immunogenicity
Timepoint [8] 0 0
13.5 months
Secondary outcome [9] 0 0
Pharmacokinetics of MEDI6570 Cmax
Timepoint [9] 0 0
13.5 months
Secondary outcome [10] 0 0
Pharmacokinetics of MEDI6570 Terminal Half-life
Timepoint [10] 0 0
13.5 months
Secondary outcome [11] 0 0
LVEF
Timepoint [11] 0 0
9 months
Secondary outcome [12] 0 0
Global Longitudinal Strain (GLS)
Timepoint [12] 0 0
9 months
Secondary outcome [13] 0 0
ADA titer
Timepoint [13] 0 0
13.5 months

Eligibility
Key inclusion criteria
1. Participant must provide informed consent before any study specific activities are performed, must be able and willing to meet all requirements for randomization within 42 days after signing the full ICF, and must adhere to the schedules of activities.
2. Women must be = 40 years of age at the time of signing the ICF. Men must be = 21 years of age at the time of signing the ICF.
3. Participant must:

1. be 30 to 365 days after presumed type-1 (ie, due to plaque rupture or erosion) MI (either STEMI or NSTEMI) at the time of enrollment.
2. have persistent inflammation, defined as hs CRP = 1 mg/L, as measured centrally at screening Visit 1.
4. Participant must have body mass index within the range 18 to 40 kg/m2 inclusive.
5. For female participants, the participant must not be pregnant or lactating and must be of non-childbearing potential, confirmed at screening Visit 1 by one of the following:

1. Postmenopausal, defined as amenorrhea for = 12 months following cessation of all exogenous hormonal treatments, and with luteinizing hormone and follicle stimulating hormone levels in the postmenopausal range.
2. Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy. Tubal ligation is not considered as irreversible surgical sterilization.
6. Participant must have an evaluable, pre-randomization CTA with quantifiable, non calcified plaque.
Minimum age
21 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. History of any clinically important disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or influence the results or the participant's ability to participate in the study.
2. Percutaneous coronary intervention or diagnostic angiogram planned after screening. Eligible participants who have a diagnostic angiogram performed in the absence of undergoing a new PCI may continue screening after the diagnostic angiogram has been performed or may be rescreened.
3. History of or planned coronary artery bypass grafting.
4. Documented episode of post-MI pericarditis in the 3 months before enrollment.
5. Ongoing New York Heart Association Class IV HF.
6. Increased risk of bleeding

1. Patients with history or presence of any bleeding disorder.
2. Signs of ongoing bleeding at screening (eg, identified macroscopic bleeding, low hemoglobin presumed to be caused by bleeding) or high risk for major bleeding in accordance with the Investigator's assessment.
3. Need for chronic therapeutic anticoagulation therapy anticipated to be required throughout the course of the study (short-term treatment with prophylactic doses of heparin/low molecular weight heparin are allowed).
4. Known severe liver disease.
7. History or presence of any of the following:

1. Ongoing infection or febrile illness that in the opinion of the investigator may be the cause of elevated hs-CRP on screening.
2. Ongoing atrial fibrillation or flutter.
3. Cancer within 5 years before randomization, with the exception of non melanoma skin cancer.
4. Alcohol or substance abuse within 6 months before randomization, as judged by the investigator.
5. Known history of hypersensitivity reactions to other biologics, to human IgG preparations, or to any component of MEDI6570, or ongoing severe allergy as judged by the investigator.
6. Patients with active positive results on screening for serum hepatitis B surface antigen, hepatitis C antibody, or HIV.
8. Any clinically important abnormalities in clinical chemistry, hematology, coagulation parameters, as judged by the investigator.
9. BP values at screening:

1. Systolic BP < 90 mmHg or > 180 mmHg.
2. Diastolic BP > 100 mmHg.
3. Participants who are excluded based on elevated BP may be rescreened following adequate treatment.
10. Participants with any of the following contraindications to CTA:

1. eGFR < 50 mL/min/1.73 m2 by the Chronic Kidney Disease Epidemiology Collaboration equation, or end stage renal disease treated with kidney transplant or renal replacement therapy.
2. Allergy to iodinated contrast.
3. History of contrast-induced nephropathy.
4. Contraindication to nitroglycerin.
5. Rapid heart rate that is uncontrolled by medical therapy.
6. Inability to hold breath for at least 6 seconds.
11. Receipt of any investigational device or therapy within 6 months or 5 half lives before screening (whichever is longer).

This criterion does NOT apply for inactive, non replicating COVID-19 vaccines approved by Health Authorities or under emergency use authorization.
12. Planned participation in an additional investigational study of an intervention or biologic before the end of the follow-up period. Participation in observational studies or studies without investigational drugs or devices is allowed.
13. Participants who are legally institutionalized.
14. An employee or close relative of an employee of the sponsor, the CRO, or the study site, regardless of the employee or close relative's role.

Study design
Purpose of the study
Treatment
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 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
4/11/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
8/11/2023
Sample size
Target
Accrual to date
Final
423
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Adelaide
Recruitment hospital [2] 0 0
Research Site - Bedford Park
Recruitment hospital [3] 0 0
Research Site - Clayton
Recruitment hospital [4] 0 0
Research Site - Murdoch
Recruitment hospital [5] 0 0
Research Site - Perth
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
5042 - Bedford Park
Recruitment postcode(s) [3] 0 0
3168 - Clayton
Recruitment postcode(s) [4] 0 0
WA6150 - Murdoch
Recruitment postcode(s) [5] 0 0
WA 6000 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Indiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Iowa
Country [7] 0 0
United States of America
State/province [7] 0 0
Michigan
Country [8] 0 0
United States of America
State/province [8] 0 0
Missouri
Country [9] 0 0
United States of America
State/province [9] 0 0
New Jersey
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
Country [11] 0 0
United States of America
State/province [11] 0 0
Ohio
Country [12] 0 0
United States of America
State/province [12] 0 0
South Dakota
Country [13] 0 0
United States of America
State/province [13] 0 0
Virginia
Country [14] 0 0
United States of America
State/province [14] 0 0
Wisconsin
Country [15] 0 0
Canada
State/province [15] 0 0
Ontario
Country [16] 0 0
Canada
State/province [16] 0 0
Quebec
Country [17] 0 0
Czechia
State/province [17] 0 0
Brno
Country [18] 0 0
Czechia
State/province [18] 0 0
Hradec Králové
Country [19] 0 0
Czechia
State/province [19] 0 0
Liberec
Country [20] 0 0
Czechia
State/province [20] 0 0
Pardubice
Country [21] 0 0
Czechia
State/province [21] 0 0
Plzen - Bory
Country [22] 0 0
Czechia
State/province [22] 0 0
Praha 5
Country [23] 0 0
Hungary
State/province [23] 0 0
Budapest
Country [24] 0 0
Hungary
State/province [24] 0 0
Debrecen
Country [25] 0 0
Hungary
State/province [25] 0 0
Székesfehérvár
Country [26] 0 0
Italy
State/province [26] 0 0
Cona
Country [27] 0 0
Italy
State/province [27] 0 0
Milan
Country [28] 0 0
Italy
State/province [28] 0 0
Parma
Country [29] 0 0
Italy
State/province [29] 0 0
Rozzano
Country [30] 0 0
Japan
State/province [30] 0 0
Himeji-shi
Country [31] 0 0
Japan
State/province [31] 0 0
Kasuga-shi
Country [32] 0 0
Japan
State/province [32] 0 0
Kasugai-shi
Country [33] 0 0
Japan
State/province [33] 0 0
Kitakyushu-shi
Country [34] 0 0
Japan
State/province [34] 0 0
Kumamoto-shi
Country [35] 0 0
Japan
State/province [35] 0 0
Kyoto-shi
Country [36] 0 0
Japan
State/province [36] 0 0
Matsudo-Shi
Country [37] 0 0
Japan
State/province [37] 0 0
Minami-ku
Country [38] 0 0
Japan
State/province [38] 0 0
Miyazaki-shi
Country [39] 0 0
Japan
State/province [39] 0 0
Morioka-shi
Country [40] 0 0
Japan
State/province [40] 0 0
Osaka-shi
Country [41] 0 0
Japan
State/province [41] 0 0
Sendai-shi
Country [42] 0 0
Netherlands
State/province [42] 0 0
Alkmaar
Country [43] 0 0
Netherlands
State/province [43] 0 0
Deventer
Country [44] 0 0
Netherlands
State/province [44] 0 0
Heerlen
Country [45] 0 0
Netherlands
State/province [45] 0 0
Nijmegen
Country [46] 0 0
Netherlands
State/province [46] 0 0
Tilburg
Country [47] 0 0
Netherlands
State/province [47] 0 0
Utrecht
Country [48] 0 0
Netherlands
State/province [48] 0 0
Venlo
Country [49] 0 0
Netherlands
State/province [49] 0 0
Zwolle
Country [50] 0 0
Poland
State/province [50] 0 0
Bialystok
Country [51] 0 0
Poland
State/province [51] 0 0
Bydgoszcz
Country [52] 0 0
Poland
State/province [52] 0 0
Katowice
Country [53] 0 0
Poland
State/province [53] 0 0
Krakow
Country [54] 0 0
Poland
State/province [54] 0 0
Kraków
Country [55] 0 0
Poland
State/province [55] 0 0
Opole
Country [56] 0 0
Poland
State/province [56] 0 0
Wroclaw
Country [57] 0 0
Spain
State/province [57] 0 0
Barcelona
Country [58] 0 0
Spain
State/province [58] 0 0
El Palmar
Country [59] 0 0
Spain
State/province [59] 0 0
Hospitalet de Llobregat(Barcel
Country [60] 0 0
Spain
State/province [60] 0 0
Madrid
Country [61] 0 0
Spain
State/province [61] 0 0
Pontevedra
Country [62] 0 0
Spain
State/province [62] 0 0
Santiago de Compostela
Country [63] 0 0
Spain
State/province [63] 0 0
Sevilla
Country [64] 0 0
United Kingdom
State/province [64] 0 0
Aylesbury
Country [65] 0 0
United Kingdom
State/province [65] 0 0
Exeter
Country [66] 0 0
United Kingdom
State/province [66] 0 0
Middlesborough
Country [67] 0 0
United Kingdom
State/province [67] 0 0
Newcastle upon Tyne
Country [68] 0 0
United Kingdom
State/province [68] 0 0
Wythenshawe

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Thrombolysis in Myocardial Infarction (TIMI) Study Group
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Available to whom?
When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://astrazenecagroup-dt.pharmacm.com/DT/Home


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/NCT04610892