MEDI6570 for Heart Attack

(GOLDILOX Trial)

No longer recruiting at 96 trial locations

Overseen By AstraZeneca Clinical Study Information Center

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: AstraZeneca

Must not be taking: Anticoagulants

Disqualifiers: Coronary bypass, Class IV HF, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 36 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of a new treatment, MEDI6570, for individuals who have experienced a heart attack. Researchers aim to determine if this treatment can reduce heart inflammation, a common issue after a heart attack. Participants will receive either varying doses of MEDI6570 or a placebo (a harmless, inactive substance) through monthly injections. This study suits those who have had a heart attack in the past year and are experiencing ongoing inflammation, indicated by specific blood markers. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, if you are on chronic therapeutic anticoagulation therapy, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that MEDI6570 has undergone safety testing in people before. In earlier studies, most patients tolerated it well. Some side effects occurred, but they were usually mild, such as injection site reactions and headaches. Serious side effects were rare.

Since this trial is in Phase 2, more safety information is available. Treatments in this phase have already passed initial safety checks in earlier studies, providing some confidence in their safety for further testing. However, every new trial aims to gather additional information on both safety and effectiveness. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for heart attack?

Researchers are excited about MEDI6570 for heart attack treatment because it offers a novel approach compared to existing options like beta-blockers, ACE inhibitors, and statins. MEDI6570 is administered through a monthly subcutaneous injection, which could improve patient compliance and convenience. Unlike traditional treatments that primarily manage symptoms and risk factors, MEDI6570 works by targeting specific pathways involved in heart attack recovery, potentially offering more direct and effective healing. This innovative mechanism of action could lead to improved outcomes for patients recovering from heart attacks.

What evidence suggests that this trial's treatments could be effective for heart attack?

Research has shown that MEDI6570 might reduce the risk of death, heart attacks, and strokes by about 15%, which is significant for individuals with a history of heart attacks. However, it does not appear to lower cholesterol, a blood fat often associated with heart problems. The treatment targets specific bodily processes that contribute to heart disease. Early studies suggest it could be a promising option for preventing future heart issues. Participants in this trial will receive varying doses of MEDI6570 or a placebo to assess its effectiveness and safety. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

Inclusion Criteria

You had a heart attack caused by plaque rupture or erosion between 30 to 365 days ago.

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.

Exclusion Criteria

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.

You have had pericarditis (inflammation around the heart) within 3 months before joining the study.

You have severe heart failure that is currently causing significant limitations in your daily activities.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive monthly subcutaneous administration of MEDI6570 or placebo

36 weeks

Monthly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

10-20 weeks

Regular follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

• MEDI6570

How Is the Trial Designed?

Group I: MEDI6570 Medium dose Experimental Treatment 1 Intervention

Monthly Subcutaneous administration.

Group II: MEDI6570 Low dose Experimental Treatment 1 Intervention

Monthly Subcutaneous administration.

Group III: MEDI6570 High dose Experimental Treatment 1 Intervention

Monthly Subcutaneous administration.

Group IV: Placebo Medium dose Placebo Group 1 Intervention

Monthly Subcutaneous administration

Group V: Placebo High dose Placebo Group 1 Intervention

Monthly Subcutaneous administration

Group VI: Placebo Low dose Placebo Group 1 Intervention

Monthly Subcutaneous administration.

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

The TIMI Study Group

Collaborator

Trials

22

Recruited

129,000+

Thrombolysis in Myocardial Infarction (TIMI) Study Group

Collaborator

Trials

2

Recruited

1,000+

Citations

1. astrazenecaclinicaltrials.com astrazenecaclinicaltrials.com/study/D4920C00002

Efficacy and Safety of MEDI6570 in Patients with a History ... A Phase IIB Parallel group Study to Evaluate the Efficacy and Safety of MEDI6570 in Participants with a Prior Myocardial Infarction.

2. trial.medpath.com trial.medpath.com/clinical-trial/725af45f4bbf7b04/euctr2020-000840-75-pl-phase-2b-study-medi6570-myocardial-infarction

A Study to Evaluate the Efficacy and Safety of MEDI6570 in ... A Study to Evaluate the Efficacy and Safety of MEDI6570 in Participantswith a Prior Heart Attack. Phase 1. Active, not recruiting. Conditions. Myocardial ...

3. ahajournals.org ahajournals.org/doi/10.1161/JAHA.122.027540

Lectin‐Like Oxidized Low‐Density Lipoprotein Receptor 1 ... ... trial showed a 15% relative risk reduction in death, myocardial infarction, and stroke, but without any significant reduction in lipid levels.

4. frfr-prd-astrazeneca-keystone-engage.app-trialscope.com frfr-prd-astrazeneca-keystone-engage.app-trialscope.com/study/D4920C00002/

Efficacy and Safety of MEDI6570 in Patients with a History of ... A Phase IIB Parallel group Study to Evaluate the Efficacy and Safety of MEDI6570 in Participants with a Prior Myocardial Infarction.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04610892

Efficacy and Safety of MEDI6570 in Patients With a History ... A Phase IIB Parallel group Study to Evaluate the Efficacy and Safety of MEDI6570 in Participants with a Prior Myocardial Infarction. Detailed Description. This ...

6. centerwatch.com centerwatch.com/clinical-trials/listings/NCT04610892/efficacy-and-safety-of-medi6570-in-patients-with-a-history-of-myocardial-infarction?activelyRecruiting=false&page=492&id=936&slug=cardiac-disease

Efficacy and Safety of MEDI6570 in Patients With a History ... A Phase IIB Parallel group Study to Evaluate the Efficacy and Safety of MEDI6570 in Participants with a Prior Myocardial Infarction.

7. s3.amazonaws.com s3.amazonaws.com/ctr-med-7111/D4920C00002/4135a31f-bf26-4a01-bd9c-fda516aec2ef/00441e4a-17e8-47dd-bd19-41bdc82aa5e0/D4920C00002-_redacted_CSR_synopsis-v1.pdf

A Phase IIB, Randomized, Double-blinded, Placebo- ... Parallel-group Study to Evaluate the Efficacy and Safety of. MEDI6570 in Participants with a Prior Myocardial Infarction,. Persistent ...

8. trial.medpath.com trial.medpath.com/clinical-trial/a8c1c9d6d0a44f4c/euctr2020-000840-75-cz-medi6570-myocardial-infarction-inflammation-safety

A Study to Evaluate the Efficacy and Safety of MEDI6570 in ... A Study to Evaluate the Efficacy and Safety of MEDI6570 in Participantswith a Prior Heart Attack. Phase 1. Active, not recruiting. Conditions. Myocardial ...