MEDI6570 for Heart Attack

(GOLDILOX Trial)

Recruiting at 86 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

423 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing MEDI6570, a new medication that aims to reduce inflammation in people who have had a heart attack. The goal is to see if it can help prevent more heart problems. The study will help decide how to use this medication in future treatments.

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.

Eligibility Criteria

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

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

Treatment Details

Interventions

• MEDI6570

Participant Groups

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+