Health Condition 1: I708- Atherosclerosis of other arteries
Conditions
Interventions
Intervention1: nil: nil
Control Intervention1: nil: nil
Sponsors
TORRENT PHARMA
Eligibility
Inclusion criteria
Inclusion criteria: 1 Male or female patients more than 18 years of age 2 Cases of ASCVD with ACS that have undergone PCI 3 Baseline LDL-C = 120 mg/dL during PCI or ?70 mg/dl for cases already receiving statin 4 Clinical cases requiring lipid goal target as less than or equal 55 mg/dl or less than equal 40 mg/dl as per ESC risk stratification for ACS and/or HeFH cases
Exclusion criteria
Exclusion criteria: 1 Hypersensitivity to the active substance or to any of the excipients. 2 Total fasting triglyceride =500 mg/dL 3 Body Mass Index (BMI) =50kg/m2 4 Gout 5 Uncontrolled Hypertension, T2DM, CSA or Heart failure 6 CKD with eGFR 7 Hepatic enzyme elevation X2 ULN 8 For women, currently pregnant (confirmed with positive pregnancy test) or breast-feeding 9 Concomitant use with simvastatin OR pravastatin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1 LDL C change in 6 Weeks in both arms 2 Responder rates for achieving LDL C less than or equal 55 or less than or equal 40 mg in 6 Weeks in both armsTimepoint: 6 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 Responder rates for achieving LDL C less than or equal 55 or less than or equal 40 mg at 12W in both arms 2 Proportion of participants with treatment emergent adverse event during observation period 3 Percent change in LDL C, non HDL C, Apo B, Lp a, hs CRP at 6 and 12 weeks 4 Responder rates for achieving LDL C less than or equal 55 or less than or equal 40 mg at 6 and 12 weeks for the subgroups with T2D, polyvascular disease, HeFH and High risk ASCVD {Two or more of following: Family history of; TG more than 170 mg/dl; hs-CRP more than 2 mg/dl; Smoking, Obesity, Apo B more than 130 mg/dl 5 LVD assessment for cases with polyvascular disease who have undergone CABG or Stent with or without T2D at 12 weeksTimepoint: 6 weeks and 12 weeks | — |
Countries
India
Contacts
Public ContactDr Krishna prasad
MADRAS MEDICAL MISSION
Outcome results
None listed