Coronary Heart Disease (CHD)Phase 2GOLDILOXNCT04610892
Efficacy and Safety of MEDI6570 in Patients With a History of Myocardial Infarction
A Phase 2 study testing MEDI6570 in people with Coronary Heart Disease (CHD), run by AstraZeneca at 84 sites in 11 countries.
Trial summary
A Phase IIB Parallel group Study to Evaluate the Efficacy and Safety of MEDI6570 in Participants with a Prior Myocardial Infarction. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Coronary Heart Disease (CHD)
- What is being tested?
- MEDI6570
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 423 participants
- Where
- 84 sitesin 11 countries
- Study dates
- 4 Nov 2020to 8 Nov 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
Show all 34Show fewer
- 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.
- 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.
- Patients with active positive results on screening for serum hepatitis B surface antigen, hepatitis C antibody, or HIV.
- Any clinically important abnormalities in clinical chemistry, hematology, coagulation parameters, as judged by the investigator.
- BP values at screening:
- Systolic BP < 90 mmHg or > 180 mmHg.
- Diastolic BP > 100 mmHg.
- Participants who are excluded based on elevated BP may be rescreened following adequate treatment.
- Participants with any of the following contraindications to CTA:
- 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.
- Allergy to iodinated contrast.
- History of contrast-induced nephropathy.
- Contraindication to nitroglycerin.
- Rapid heart rate that is uncontrolled by medical therapy.
- Inability to hold breath for at least 6 seconds.
- 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.
- 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.
- Participants who are legally institutionalized.
- 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.
Trial locations and contacts
84 sites in 11 countries.
84 sites in 11 countries
United States19 sites
Research Site
Beverly Hills, California, 90211
Research Site
Buffalo, New York, 14221
Research Site
Canton, Ohio, 44710
Research Site
Columbia, Missouri, 65212
Research Site
Covina, California, 91723
Research Site
Decatur, Georgia, 30033
Research Site
Madison, Wisconsin, 53792
Research Site
Midland, Michigan, 48640
Research Site
Mobile, Alabama, 36608
Research Site
Muncie, Indiana, 47303
Research Site
New Brunswick, New Jersey, 08901
Research Site
Northridge, California, 91324
Research Site
Northridge, California, 91325
Research Site
Ponte Vedra, Florida, 32081
Research Site
Rapid City, South Dakota, 57701
Research Site
Richmond, Indiana, 47374
Research Site
Torrance, California, 90502
Research Site
West Des Moines, Iowa, 50266
Research Site
Winchester, Virginia, 22601
Japan12 sites
Research Site
Himeji-shi, 670-0981
Research Site
Kasuga-shi, 816-0864
Research Site
Kasugai-shi, 487-0016
Research Site
Kitakyushu-shi, 802-8555
Research Site
Kumamoto, 860-0008
Research Site
Kyoto, 606-8507
Research Site
Matsudo-Shi, 271-0077
Research Site
Minamiku, 861-4193
Research Site
Miyazaki, 880-0834
Research Site
Morioka, 020-0066
Research Site
Osaka, 558-8558
Research Site
Sendai, 980-0873
Netherlands9 sites
Research Site
Alkmaar, 1814 HB
Research Site
Deventer, 7416 SE
Research Site
Heerlen, 6419 PC
Research Site
Nijmegen, 6525 GA
Research Site
Nijmegen, 6532 SZ
Research Site
Tilburg, 5042AD
Research Site
Utrecht, 3508 AB
Research Site
Venlo, 5912 BL
Research Site
Zwolle, 8025 AB
Poland8 sites
Research Site
Bialystok, 15-276
Research Site
Bydgoszcz, 85-095
Research Site
Katowice, 40-635
Research Site
Krakow, 30-082
Research Site
Krakow, 30-688
Research Site
Krakow, 31-202
Research Site
Opole, 45-401
Research Site
Wroclaw, 50-556
Spain8 sites
Research Site
Barcelona, 08003
Research Site
El Palmar, 30120
Research Site
Hospitalet de Llobregat(Barcel, 08907
Research Site
Madrid, 28040
Research Site
Madrid, 28046
Research Site
Pontevedra, 36312
Research Site
Santiago de Compostela, 15706
Research Site
Seville, 41009
Czechia6 sites
Research Site
Brno, 656 91
Research Site
Hradec Králové, 500-05
Research Site
Liberec, 46002
Research Site
Pardubice, 532 03
Research Site
Plzen - Bory, 305 99
Research Site
Prague, 150 06
Australia5 sites
Research Site
Adelaide, 5000
Research Site
Bedford Park, 5042
Research Site
Clayton, 3168
Research Site
Murdoch, WA6150
Research Site
Perth, WA 6000
Hungary5 sites
Research Site
Budapest, 1133
Research Site
Budapest, 1134
Research Site
Budapest, H-1122
Research Site
Debrecen, 4032
Research Site
Székesfehérvár, 8000
United Kingdom5 sites
Research Site
Aylesbury, HP21 8AL
Research Site
Exeter, EX2 5DW
Research Site
Middlesbrough, TS4 3BW
Research Site
Newcastle upon Tyne, NE7 7DN
Research Site
Wythenshawe, M23 9LT
Italy4 sites
Research Site
Cona, 44124
Research Site
Milan, 20138
Research Site
Parma, 43126
Research Site
Rozzano, 20089
Canada3 sites
Research Site
Montreal, Quebec, H1T 1C8
Research Site
Ottawa, Ontario, K1Y 4W7
Research Site
Toronto, Ontario, M5G 2C4
About this study
Official 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
A Phase IIB Parallel group Study to Evaluate the Efficacy and Safety of MEDI6570 in Participants with a Prior Myocardial Infarction.
Read the detailed description
This Phase IIB, proof-of-concept, dose-range finding clinical study is being conducted to evaluate the anti-inflammatory potential of MEDI6570 and its effect on surrogates for atherosclerotic and heart failure (HF) events in patients with a history of myocardial infarction (MI). The results of the Phase IIB study will inform future clinical development options and precision medicine strategy for future clinical studies.
Participants will be randomized in a 2:2:1:1 ratio after protocol Amend 2, 360 evaluable participants (111 evaluable participants in each of the 2 MEDI6570 groups, plus 27 evaluable participants in the legacy low dose MEDI6570 group, plus 111 participants in pooled placebo) will complete the study.
- Conditions
- Coronary Heart Disease (CHD)
- Being tested
- MEDI6570, Placebo
- Keywords
- Coronary Heart Disease, Atherosclerosis
- Medical subject headings
- Coronary Disease, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEDI6570Biological
MEDI6570
PlaceboBiological
Buffer
| Study group | Role | What they receive |
|---|---|---|
| MEDI6570 Low dose | Experimental | Monthly Subcutaneous administration. Receives: Biological: MEDI6570 |
| MEDI6570 Medium dose | Experimental | Monthly Subcutaneous administration. Receives: Biological: MEDI6570 |
| MEDI6570 High dose | Experimental | Monthly Subcutaneous administration. Receives: Biological: MEDI6570 |
| Placebo Low dose | Placebo comparator | Monthly Subcutaneous administration. Receives: Biological: Placebo |
| Placebo Medium dose | Placebo comparator | Monthly Subcutaneous administration Receives: Biological: Placebo |
| Placebo High dose | Placebo comparator | Monthly Subcutaneous administration Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline to Day 253
Secondary outcomes (15)
Change From Baseline to Day 253 in N Terminal Prohormone Brain Natriuretic Peptide (NT-proBNP)
To evaluate the effect of MEDI6570 on a surrogate biomarker of Heart Failure (HF) compared with placebo
Measured: From baseline to Day 253
Change From Baseline to Day 253 in Left Ventricular Ejection Fraction (LVEF)
To evaluate the effect of MEDI6570 on left ventricular systolic function compared with placebo
Measured: From baseline to Day 253
Left Ventricular Ejection Fraction (LVEF) Change From Baseline to Day 253 Among Subjects With Reduced Ejection Fraction (< 50%)
To evaluate the effect of MEDI6570 on left ventricular systolic function among participants with reduced ejection fraction (defined as <50%) compared with placebo
Measured: From baseline to Day 253
Change From Baseline to Day 253 in Global Longitudinal Strain (GLS)
To evaluate the effect of MEDI6570 on left ventricular systolic function compared with placebo
Measured: From baseline to Day 253
Global Longitudinal Strain (GLS) Change From Baseline to Day 253 Among Subjects With Reduced Ejection Fraction (< 50%)
To evaluate the effect of MEDI6570 on left ventricular systolic function among participants with reduced ejection fraction (defined as <50%) compared with placebo
Measured: From baseline to Day 253
Change From Baseline to Day 253 in Global Non-calcified Plaque Volume (NCPV)
To evaluate the effect of MEDI6570 on other measures of non-calcified coronary atherosclerotic plaque compared with placebo
Measured: From baseline to Day 253
Change From Baseline to Day 253 in Low Attenuation Plaque Volume (LAPV)
To evaluate the effect of MEDI6570 on other measures of non-calcified coronary atherosclerotic plaque compared with placebo
Measured: From baseline to Day 253
Summary of ADA (Anti-drug Antibody) Responses During the Study
To evaluate the immunogenicity of MEDI6570
Measured: From baseline to Day 325/405. Day 325/405: for participants who completed the study under clinical study protocol (CSP) Amendment 1 & 2, the end of study visits were Day 405 and Day 325 respectively.
Anti-drug Antibody Titre Summary by Visit
To evaluate the immunogenicity of MEDI6570
Measured: From Baseline to Day 325/405. Day 325/405: for participants who completed the study under CSP Amendment 1 & 2, the end of study visits were Day 405 and Day 325 respectively.
Summary of Serum Concentrations (ug/mL) of MEDI6570
MEDI6570 concentrations as measured in serum during the intervention and follow-up periods
Measured: From baseline to Day 325/Day 405
Number of Participants With Adverse Events in Any Category
To assess the safety and tolerability of MEDI6570 compared with placebo
Measured: During study follow-up (from day 1 to day 325)
Number of Participants With Most Common Adverse Events (Frequency > 5%)
To assess the safety and tolerability of MEDI6570 compared with placebo
Measured: During study follow-up (from day 1 to day 325)
Vital Signs (Change in Systolic and Diastolic Blood Pressure From Baseline) Over Time
To assess the safety and tolerability of MEDI6570 compared with placebo
Measured: From baseline to Day 325/405. Day 325/405: for participants who completed the study under CSP Amendment 1 & 2, the end of study visits were Day 405 and Day 325 respectively.
Vital Signs (Change in Heart Rate From Baseline) Variables Over Time
To assess the safety and tolerability of MEDI6570 compared with placebo
Measured: From baseline to Day 325/405. Day 325/405: for participants who completed the study under CSP Amendment 1 & 2, the end of study visits were Day 405 and Day 325 respectively.
Vital Signs (Change of Weight From Baseline to Day 325/405 )
To assess the safety and tolerability of MEDI6570 compared with placebo
Measured: From baseline to Day 325/405. Day 325/405: for participants who completed the study under CSP Amendment 1 & 2, the end of study visits were Day 405 and Day 325 respectively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2020
- Study start4 Nov 2020
- Primary completion8 Nov 2023
- Study completion8 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Coronary Heart Disease (CHD)Studies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 423 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The TIMI Study Group
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04610892
- Sponsor's protocol ID
- D4920C00002
- Other IDs
- 2020-000840-75
- Acronym
- GOLDILOX
- Status last verified
- Jan 2025
- First submitted
- 28 Jul 2020
- Last updated
- 21 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04610892
- Acronym / sponsor ID
- GOLDILOX / D4920C00002
- Conditions
- Coronary Heart Disease (CHD)
- Keywords
- Coronary Heart Disease, Atherosclerosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 423 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- The TIMI Study Group
- Study start
- 4 Nov 2020 (actual)
- Primary completion
- 8 Nov 2023 (actual)
- Study completion
- 8 Nov 2023 (actual)
- First posted
- 2 Nov 2020 (actual)
- Results
- Posted 21 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase IIB Parallel group Study to Evaluate the Efficacy and Safety of MEDI6570 in Participants with a Prior Myocardial Infarction.
Detailed description
This Phase IIB, proof-of-concept, dose-range finding clinical study is being conducted to evaluate the anti-inflammatory potential of MEDI6570 and its effect on surrogates for atherosclerotic and heart failure (HF) events in patients with a history of myocardial infarction (MI). The results of the Phase IIB study will inform future clinical development options and precision medicine strategy for future clinical studies.
Participants will be randomized in a 2:2:1:1 ratio after protocol Amend 2, 360 evaluable participants (111 evaluable participants in each of the 2 MEDI6570 groups, plus 27 evaluable participants in the legacy low dose MEDI6570 group, plus 111 participants in pooled placebo) will complete the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| MEDI6570 Low dose | Experimental | Biological: MEDI6570Monthly Subcutaneous administration. |
| MEDI6570 Medium dose | Experimental | Biological: MEDI6570Monthly Subcutaneous administration. |
| MEDI6570 High dose | Experimental | Biological: MEDI6570Monthly Subcutaneous administration. |
| Placebo Low dose | Placebo comparator | Biological: PlaceboMonthly Subcutaneous administration. |
| Placebo Medium dose | Placebo comparator | Biological: PlaceboMonthly Subcutaneous administration |
| Placebo High dose | Placebo comparator | Biological: PlaceboMonthly Subcutaneous administration |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
- 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:
Key exclusion criteria (34 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MEDI6570MEDI6570 | Biological | MEDI6570 High dose, MEDI6570 Low dose, MEDI6570 Medium dose |
| PlaceboBuffer | Biological | Placebo High dose, Placebo Low dose, Placebo Medium dose |
Primary outcome
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
Time frame: From baseline to Day 253
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.
15 secondary outcomes
Change From Baseline to Day 253 in N Terminal Prohormone Brain Natriuretic Peptide (NT-proBNP)
Time frame: From baseline to Day 253
Change From Baseline to Day 253 in Left Ventricular Ejection Fraction (LVEF)
Time frame: From baseline to Day 253
Left Ventricular Ejection Fraction (LVEF) Change From Baseline to Day 253 Among Subjects With Reduced Ejection Fraction (< 50%)
Time frame: From baseline to Day 253
Change From Baseline to Day 253 in Global Longitudinal Strain (GLS)
Time frame: From baseline to Day 253
Global Longitudinal Strain (GLS) Change From Baseline to Day 253 Among Subjects With Reduced Ejection Fraction (< 50%)
Time frame: From baseline to Day 253
Change From Baseline to Day 253 in Global Non-calcified Plaque Volume (NCPV)
Time frame: From baseline to Day 253
Change From Baseline to Day 253 in Low Attenuation Plaque Volume (LAPV)
Time frame: From baseline to Day 253
Summary of ADA (Anti-drug Antibody) Responses During the Study
Time frame: From baseline to Day 325/405. Day 325/405: for participants who completed the study under clinical study protocol (CSP) Amendment 1 & 2, the end of study visits were Day 405 and Day 325 respectively.
Anti-drug Antibody Titre Summary by Visit
Time frame: From Baseline to Day 325/405. Day 325/405: for participants who completed the study under CSP Amendment 1 & 2, the end of study visits were Day 405 and Day 325 respectively.
Summary of Serum Concentrations (ug/mL) of MEDI6570
Time frame: From baseline to Day 325/Day 405
Number of Participants With Adverse Events in Any Category
Time frame: During study follow-up (from day 1 to day 325)
Number of Participants With Most Common Adverse Events (Frequency > 5%)
Time frame: During study follow-up (from day 1 to day 325)
Vital Signs (Change in Systolic and Diastolic Blood Pressure From Baseline) Over Time
Time frame: From baseline to Day 325/405. Day 325/405: for participants who completed the study under CSP Amendment 1 & 2, the end of study visits were Day 405 and Day 325 respectively.
Vital Signs (Change in Heart Rate From Baseline) Variables Over Time
Time frame: From baseline to Day 325/405. Day 325/405: for participants who completed the study under CSP Amendment 1 & 2, the end of study visits were Day 405 and Day 325 respectively.
Vital Signs (Change of Weight From Baseline to Day 325/405 )
Time frame: From baseline to Day 325/405. Day 325/405: for participants who completed the study under CSP Amendment 1 & 2, the end of study visits were Day 405 and Day 325 respectively
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- redacted CSPLink provided by the sponsor.
- redacted SAPLink provided by the sponsor.
- redacted CSRLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
84 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MEDI6570 in people with Coronary Heart Disease (CHD), run by AstraZeneca at 84 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 84 sites in United States, Japan, Netherlands, Poland, Spain and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: From baseline to Day 253). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2025.