Study to Evaluate the Effectiveness of Deferiprone Capsules in Patients Recovering from a Recent Heart Attack

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1)To assess the Percentage reduction of hemorrhagic zone heme content by using Late Gadolinium Enhancement (LGE) contrast based Cardiac Magnetic Resonance Imagining (MRI) T2 mapping weighted images and quantification <br/ ><br>2)To assess the Percentage changes in Infarct Size and Left Ventricular Ejection Fraction (LVEF) using Late Gadolinium Enhancement (LGE) contrast based Cardiac MRITimepoint: Baseline and Day 90 ± 3 days

Secondary Outcome Measures