Efficacy and Safety of MEDI6570 in Patients With a History of Myocardial Infarction
GOLDILOX
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
2 other identifiers
interventional
423
11 countries
84
Brief Summary
A Phase IIB Parallel group Study to Evaluate the Efficacy and Safety of MEDI6570 in Participants with a Prior Myocardial Infarction.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2020
Typical duration for phase_2
84 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 28, 2020
CompletedFirst Posted
Study publicly available on registry
November 2, 2020
CompletedStudy Start
First participant enrolled
November 4, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 8, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 8, 2023
CompletedResults Posted
Study results publicly available
February 21, 2025
CompletedFebruary 21, 2025
January 1, 2025
3 years
July 28, 2020
November 8, 2024
January 31, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline to Day 253 in Non-calcified Plaque Volume in the Most Diseased Coronary Segment (NCPVMD), as Measured by Computed Tomography Angiography (CTA) Imaging
To evaluate the effect of MEDI6570 on non-calcified coronary atherosclerotic plaques compared with placebo. The primary endpoint of change in NCPVMD from baseline to Day 253 was assessed based on the CTA Analysis Populations.
From baseline to Day 253
Secondary Outcomes (15)
Change From Baseline to Day 253 in N Terminal Prohormone Brain Natriuretic Peptide (NT-proBNP)
From baseline to Day 253
Change From Baseline to Day 253 in Left Ventricular Ejection Fraction (LVEF)
From baseline to Day 253
Left Ventricular Ejection Fraction (LVEF) Change From Baseline to Day 253 Among Subjects With Reduced Ejection Fraction (< 50%)
From baseline to Day 253
Change From Baseline to Day 253 in Global Longitudinal Strain (GLS)
From baseline to Day 253
Global Longitudinal Strain (GLS) Change From Baseline to Day 253 Among Subjects With Reduced Ejection Fraction (< 50%)
From baseline to Day 253
- +10 more secondary outcomes
Study Arms (6)
MEDI6570 Low dose
EXPERIMENTALMonthly Subcutaneous administration.
MEDI6570 Medium dose
EXPERIMENTALMonthly Subcutaneous administration.
MEDI6570 High dose
EXPERIMENTALMonthly Subcutaneous administration.
Placebo Low dose
PLACEBO COMPARATORMonthly Subcutaneous administration.
Placebo Medium dose
PLACEBO COMPARATORMonthly Subcutaneous administration
Placebo High dose
PLACEBO COMPARATORMonthly Subcutaneous administration
Interventions
Eligibility Criteria
You may qualify if:
- 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.
- 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.
- Participant must:
- 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.
- have persistent inflammation, defined as hs CRP ≥ 1 mg/L, as measured centrally at screening Visit 1.
- Participant must have body mass index within the range 18 to 40 kg/m2 inclusive.
- 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:
- 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.
- Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy. Tubal ligation is not considered as irreversible surgical sterilization.
- Participant must have an evaluable, pre-randomization CTA with quantifiable, non calcified plaque.
You may not qualify if:
- 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.
- 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.
- History of or planned coronary artery bypass grafting.
- Documented episode of post-MI pericarditis in the 3 months before enrollment.
- Ongoing New York Heart Association Class IV HF.
- Increased risk of bleeding
- Patients with history or presence of any bleeding disorder.
- 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.
- 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).
- Known severe liver disease.
- History or presence of any of the following:
- Ongoing infection or febrile illness that in the opinion of the investigator may be the cause of elevated hs-CRP on screening.
- Ongoing atrial fibrillation or flutter.
- Cancer within 5 years before randomization, with the exception of non melanoma skin cancer.
- Alcohol or substance abuse within 6 months before randomization, as judged by the investigator.
- +19 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- The TIMI Study Groupcollaborator
Study Sites (84)
Research Site
Mobile, Alabama, 36608, United States
Research Site
Beverly Hills, California, 90211, United States
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Covina, California, 91723, United States
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Northridge, California, 91324, United States
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Northridge, California, 91325, United States
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Torrance, California, 90502, United States
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Ponte Vedra, Florida, 32081, United States
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Decatur, Georgia, 30033, United States
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Muncie, Indiana, 47303, United States
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Richmond, Indiana, 47374, United States
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West Des Moines, Iowa, 50266, United States
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Midland, Michigan, 48640, United States
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Columbia, Missouri, 65212, United States
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New Brunswick, New Jersey, 08901, United States
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Buffalo, New York, 14221, United States
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Canton, Ohio, 44710, United States
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Rapid City, South Dakota, 57701, United States
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Winchester, Virginia, 22601, United States
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Madison, Wisconsin, 53792, United States
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Adelaide, 5000, Australia
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Bedford Park, 5042, Australia
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Clayton, 3168, Australia
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Murdoch, WA6150, Australia
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Perth, WA 6000, Australia
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Ottawa, Ontario, K1Y 4W7, Canada
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Toronto, Ontario, M5G 2C4, Canada
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Montreal, Quebec, H1T 1C8, Canada
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Brno, 656 91, Czechia
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Hradec KrĂ¡lovĂ©, 500-05, Czechia
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Liberec, 46002, Czechia
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Pardubice, 532 03, Czechia
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Plzen - Bory, 305 99, Czechia
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Prague, 150 06, Czechia
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Budapest, 1133, Hungary
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Budapest, 1134, Hungary
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Budapest, H-1122, Hungary
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Debrecen, 4032, Hungary
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SzĂ©kesfehĂ©rvĂ¡r, 8000, Hungary
Research Site
Cona, 44124, Italy
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Milan, 20138, Italy
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Parma, 43126, Italy
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Rozzano, 20089, Italy
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Himeji-shi, 670-0981, Japan
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Kasuga-shi, 816-0864, Japan
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Kasugai-shi, 487-0016, Japan
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Kitakyushu-shi, 802-8555, Japan
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Kumamoto, 860-0008, Japan
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Kyoto, 606-8507, Japan
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Matsudo-Shi, 271-0077, Japan
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Minamiku, 861-4193, Japan
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Miyazaki, 880-0834, Japan
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Morioka, 020-0066, Japan
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Osaka, 558-8558, Japan
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Sendai, 980-0873, Japan
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Alkmaar, 1814 HB, Netherlands
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Deventer, 7416 SE, Netherlands
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Heerlen, 6419 PC, Netherlands
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Nijmegen, 6525 GA, Netherlands
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Nijmegen, 6532 SZ, Netherlands
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Tilburg, 5042AD, Netherlands
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Utrecht, 3508 AB, Netherlands
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Venlo, 5912 BL, Netherlands
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Zwolle, 8025 AB, Netherlands
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Bialystok, 15-276, Poland
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Bydgoszcz, 85-095, Poland
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Katowice, 40-635, Poland
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Krakow, 30-082, Poland
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Krakow, 30-688, Poland
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Krakow, 31-202, Poland
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Opole, 45-401, Poland
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Wroclaw, 50-556, Poland
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Barcelona, 08003, Spain
Research Site
El Palmar, 30120, Spain
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Hospitalet de Llobregat(Barcel, 08907, Spain
Research Site
Madrid, 28040, Spain
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Madrid, 28046, Spain
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Pontevedra, 36312, Spain
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Santiago de Compostela, 15706, Spain
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Seville, 41009, Spain
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Aylesbury, HP21 8AL, United Kingdom
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Exeter, EX2 5DW, United Kingdom
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Middlesbrough, TS4 3BW, United Kingdom
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Newcastle upon Tyne, NE7 7DN, United Kingdom
Research Site
Wythenshawe, M23 9LT, United Kingdom
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Clinical Lead
- Organization
- AstraZeneca
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 28, 2020
First Posted
November 2, 2020
Study Start
November 4, 2020
Primary Completion
November 8, 2023
Study Completion
November 8, 2023
Last Updated
February 21, 2025
Results First Posted
February 21, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- 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.
- Access Criteria
- 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.
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.