study on Heart related ailments
- Conditions
- Health Condition 1: I708- Atherosclerosis of other arteries
- Registration Number
- CTRI/2024/01/062146
- Lead Sponsor
- TORRENT PHARMA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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
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 <30 ml/min
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1 LDL C change in 6 Weeks in both arms <br/ ><br>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 Outcome Measures
Name Time Method 1 Responder rates for achieving LDL C less than or equal 55 or less than or equal 40 mg at 12W in both arms <br/ ><br>2 Proportion of participants with treatment emergent adverse event during observation period <br/ ><br>3 Percent change in LDL C, non HDL C, Apo B, Lp a, hs CRP at 6 and 12 weeks <br/ ><br>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 <br/ ><br>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