A Prospective, Multicenter, Single arm, Open Label study to Determine Cardiac MRI-Guided Deferiprone Therapy for Acute Myocardial Infarction Patients - NI

Synergy Superspecialty Hospital0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年8月19日

试验速览

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•1)Patient of either gender, aged 18 to 75 years (both inclusive)
•2)Patient with no physical limitation to ingest and retain oral medication
•3)New or newly diagnosed patients with total Index Occlusion ST Elevation Myocardial Infraction (STEMI)
•4)Patients recently underwent primary Percutaneous Coronary Intervention (PCI)
•5)Patients who understand & willing to comply with study requirements and provide written informed consent for participation
•6)Women of childbearing potential must have a negative urine pregnancy test prior to study entry and agree to use highly effective methods of contraception to prevent pregnancy

•1)Prior history of MI or PCI or coronary artery bypass graft
•2)Patients with previous history of left ventricular ejection fraction less then 40%
•3)Patients with eGFR less than 30 ml/min/1.73m2 at screening.
•4)Patients with Absolute Neutrophil Count (ANC) less than 1.0 x 109 /L at screening
•5)Elevated hepatic enzymes like Alkaline phosphatase (ALT) and/or aspartate aminotransferase (AST) more than 2 times of upper normal limit and not taking medications for chronic liver disease.
•6)Patients with Body weight more than 140 kg (or 309 lbs.) at screening
•7)Any contraindication against cardiac MRI (such as metal implants etc.) and known allergy or contra-indication to gadolinium/contrast agents.
•8)Patients with heme storage disease (hemochromatosis, thalassemia) or who are already treated with heme deactivators.
•9)Patient with history of HIV and or Hepatitis B and or Hepatitis C.
•10)Participation in any experimental drug and or device study within 60 days before screening.
•11)Any clinically significant abnormality identified prior to enrollment in the judgment of the Investigator or Delegate would preclude safe completion of the study or confound the anticipated benefit of deferiprone.
•12)Life expectancy of less than 1 year due to noncardiac pathology.
•13)The presence of any other clinically significant disease or laboratory findings that in the Investigators opinion may affect the study outcome parameter data.

发起方

Synergy Superspecialty Hospital