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Monoclonal Antibodies
MEDI6570 for Heart Attack (GOLDILOX Trial)
Phase 2
Waitlist Available
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 13.5 months
Summary
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.
Eligible Conditions
- Heart disease
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 13.5 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~13.5 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Non Calcified Plaque Volume
Secondary study objectives
ADA titer
Adverse Events as a measure of safety and tolerability of MEDI6570
Adverse events as a measure of safety and tolerability of MEDI6570
+8 moreTrial Design
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MEDI6570
2018
Completed Phase 2
~520
Find a Location
Who is running the clinical trial?
AstraZenecaLead Sponsor
4,403 Previous Clinical Trials
289,124,657 Total Patients Enrolled
Thrombolysis in Myocardial Infarction (TIMI) Study GroupUNKNOWN
1 Previous Clinical Trials
593 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.You have a history of bleeding disorders, ongoing bleeding, or are at high risk for major bleeding. You are expected to need ongoing anticoagulation therapy or have severe liver disease.You are planning to have a procedure to check your heart's blood vessels, or have had one recently, and depending on the results, you may or may not be able to join the study.You have had or are planning to have a surgery to bypass blocked arteries in your heart.You had a heart attack caused by plaque rupture or erosion between 30 to 365 days ago.You have ongoing inflammation, as shown by a blood test with high sensitivity C-reactive protein level of 1 mg/L or higher.You must have a body mass index between 18 and 40.You need to have a pre-randomization CTA with measurable, non-calcified plaque.Your blood pressure is too low (below 90) or too high (above 180 for systolic, above 100 for diastolic). If your blood pressure is too high, you may be able to be screened again after it's been brought down with treatment.You have severe kidney problems, an allergy to iodinated contrast, a history of contrast-induced kidney issues, cannot use nitroglycerin, have uncontrolled rapid heart rate, or can't hold your breath for at least 6 seconds.You have not taken any experimental treatment or device within the last 6 months, unless it is an approved COVID-19 vaccine.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo Medium dose
- Group 2: MEDI6570 Low dose
- Group 3: Placebo High dose
- Group 4: MEDI6570 Medium dose
- Group 5: MEDI6570 High dose
- Group 6: Placebo Low dose
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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