Efficacy and Safety of MEDI6570 in Patients With a History of Myocardial Infarction (GOLDILOX)
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- STATUS
- Recruiting
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- End date
- Aug 22, 2023
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- participants needed
- 400
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- sponsor
- AstraZeneca
Summary
A Phase IIB Parallel group Study to Evaluate the Efficacy and Safety of MEDI6570 in Participants with a Prior Myocardial Infarction.
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.
Details
| Condition | Coronary Heart Disease (CHD) |
|---|---|
| Treatment | Placebo, MEDI6570 |
| Clinical Study Identifier | NCT04610892 |
| Sponsor | AstraZeneca |
| Last Modified on | 23 July 2022 |
Eligibility
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