Efficacy and Safety of MEDI6570 in Patients With a History of Myocardial Infarction — GOLDILOX

Coronary Heart Disease (CHD) Clinical Trial

Official title:
A Phase IIB, Randomized, Double Blinded, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of MEDI6570 in Participants With a Prior Myocardial Infarction and Persistent Inflammation

Status Completed

Clinical Trial Summary

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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04610892
Study type	Interventional
Source	AstraZeneca
Contact
Status	Completed
Phase	Phase 2
Start date	November 4, 2020
Completion date	November 8, 2023

View Details

See also
Status	Clinical Trial	Phase
Withdrawn	`NCT01631409` - Estimation of the Long Term Effectiveness of Routine Use of Cardiac Shock Wave Therapy	N/A
Recruiting	`NCT05834673` - VICTORION-ASCERTAIN: Implementation Study (v-ASCERTAIN)	Phase 4
Completed	`NCT00685776` - Study to Assess the Tolerability and Efficacy of Anacetrapib in Patients With Coronary Heart Disease (CHD) or CHD Risk-Equivalent Disease (MK-0859-019)	Phase 3
Active, not recruiting	`NCT03872401` - Effect of Evolocumab in Patients at High Cardiovascular Risk Without Prior Myocardial Infarction or Stroke	Phase 3
Completed	`NCT03427489` - A Biorepository for Coronary Heart Disease in Qatar
Active, not recruiting	`NCT01864031` - The Role of Alcohol Consumption in the Aetiology of Different Cardiovascular Disease Phenotypes: a CALIBER Study	N/A
Not yet recruiting	`NCT05178602` - The Effect of TaiChi on Ischemic Burden of Patients With Coronary Heart Disease Complicated With Renal Insufficiency	N/A
Not yet recruiting	`NCT06216847` - Clinical Outcomes of Patients With Coronary Artery Disease
Recruiting	`NCT06170541` - CORE-COMPARE Pilot Study	N/A
Recruiting	`NCT01315834` - Couples Coping With Coronary Heart Disease	N/A