MEDI6570 for Heart Attack
(GOLDILOX Trial)
Recruiting in Palo Alto (17 mi)
+86 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Waitlist Available
Sponsor: AstraZeneca
Prior Safety Data
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.
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.
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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.
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Treatment Details
Interventions
- MEDI6570 (Monoclonal Antibodies)
Participant Groups
6Treatment groups
Experimental Treatment
Placebo Group
Group I: MEDI6570 Medium doseExperimental Treatment1 Intervention
Monthly Subcutaneous administration.
Group II: MEDI6570 Low doseExperimental Treatment1 Intervention
Monthly Subcutaneous administration.
Group III: MEDI6570 High doseExperimental Treatment1 Intervention
Monthly Subcutaneous administration.
Group IV: Placebo Medium dosePlacebo Group1 Intervention
Monthly Subcutaneous administration
Group V: Placebo High dosePlacebo Group1 Intervention
Monthly Subcutaneous administration
Group VI: Placebo Low dosePlacebo Group1 Intervention
Monthly Subcutaneous administration.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Research SitePonte Vedra, Canada
Research SiteMidland, Canada
Research SiteDecatur, Canada
Research SiteWest Des Moines, Canada
More Trial Locations
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Who Is Running the Clinical Trial?
AstraZenecaLead Sponsor
The TIMI Study GroupCollaborator
Thrombolysis in Myocardial Infarction (TIMI) Study GroupCollaborator