Study of Roxadustat in the Treatment of Acute Myocardial Infarction

Phase 2

• Conditions: ST Elevation Myocardial Infarction
• Interventions: Drug: Roxadustat

• Registration Number: NCT04803864
• Lead Sponsor: Ruijin Hospital

Brief Summary

Depite successful primary percutaneous coronary intervention (PCI) and standardized medical treatment, prognosis of acute ST-elevation myocardial infarction patents are still a poor, with high morality and various complications such as heart failure. Roxadustat is a new drug targeting hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibition and has shown promising effect in reducing infarct size in pre-clinical studies.

This study aims to evaluate the efficacy and safety of early and short-term administration of roxadustat in the treatment of acute ST-elevation myocardial infarction.

Detailed Description

This study is an open-label, paralleled, randomized controlled trial. It aims to evaluate the efficacy and safety of early and short-term administration of roxadustat in the treatment of acute ST-elevation myocardial infarction.

Study Timeline

• Study First Submitted: 2021-02-02
• Study First Submitted QC: 2021-03-16
• Study First Posted: 2021-03-18
• Study Start: 2021-06-10
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-31
• Last Update Posted: 2021-09-01
• Primary Completion: 2022-09-30
• Study Completion: 2023-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 158

Inclusion Criteria

• Acute STEMI (ST segment elevation myocardial infarction) diagnosed by ST elevation
• Coronary angiography within 12 hours of symptom onset, with TIMI flow grade 0 - 1 of culprit vessel
• Primary PCI with TIMI flow grade 2 - 3 after successful intervention
• Capable and willing to provide informed consent and capable of completing study visits

Exclusion Criteria

• Previous acute myocardial infarction history
• Cardiogenic Shock at admission
• Previously treated by roxadustat
• Contraindications of roxadustat treatment
• Contraindication of Cardiac MRI (e.g. eGFR < 30 ml/min, pacemaker, metal prosthesis, etc.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Roxadustat	Roxadustat	Early and short-term Roxadustat treatment

Primary Outcome Measures

Name	Time	Method
Infarct Size	30 days	Infarct size as a percentage of LV mass measured on delayed-enhanced CMR imaging 30 days post-MI compared to control

Secondary Outcome Measures

Name	Time	Method
MACE	0 - 1 year	Major adverse cardiovascular events (MACE) within 1 year follow-up.
Cardiac enzymes - peak concentration	0 - 3 days	Peak Plasma Concentration (Cmax) of CK-MB, TnI and CK
Left Ventricular Function	1 month, 6 months, 1 year	Left ventricular end diastolic volume (LVEDV), Left ventricular end systolic volume (LVESV), Left ventricular ejection fraction (LVEF) changes during 1 year follow-up
Cardiac enzymes - Area under curve	0 - 3 days	Area under the plasma concentration versus time curve (AUC) of CK-MB, TnI and CK

Trial Locations

Locations (1)

Ruijin Hospital; 🇨🇳 Shanghai, Shanghai, China