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IRCT20221127056625N1 IRCT 2022-12-22 National University of Medical Sciences (NUMS) Rawalpindi Genetic Polymorphism of Rosuvastatin IMPACT OF GENETIC POLYMORPHISM OF ROSUVASTATIN TRANSPORTER GENES ON ITS PLASMA LEVELS AND LIPID LOWERING EFFICACY IN HYPERLIPIDEMIC PAKISTANI PATIENTS 2022-12-05 anticipated 384 Complete https://irct.ir/trial/67147 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment, Other design features: This will be a quasi experimental clinical trial in which there will be intervention with rosuvastatin in hyperlipidemic Pakistani patients but there will be no randomization. 4 Patients of hyperlipidemia with LDLc> 130mg/dL. Intervention group: Patients will receive rosuvastatin once daily for a period of 12 weeks. No - There is not a plan to make this available Justification or reason for not sharing IPD is there is no further information
public Dr. Mahjabeen Sharif
B-342/15 street No:3 Lane No:4 peshawar road Rawalpindi
RAWALPINDI Pakistan 46000 +92 333 5077896 mahjabeen30@hotmail.com Army Medical College Rawalpindi, National University of Medical Sciences (NUMS) Rawalpindi scientific Dr. Mahjabeen Sharif
B-342/15 street No:3 Lane No:4 Peshawar road Rawalpindi
Rawalpindi Pakistan 46000 +92 333 5077896 mahjabeen30@hotmail.com Army Medical College Rawalpindi, National University of Medical Sciences (NUMS) Rawalpindi Pakistan Both males and females belonging to different Pakistani regions Age 30-70 years Patients with elevated LDL-c levels more than 130 mg/dL (3.4 mmoles/L) Patients with normal serum CPK levels 10-120 mcg/dL 30 years 70 years Both Patients taking antihyperlipidemic drugs other than rosuvastatin Hepatic and kidney diseases Patients with raised serum CPK levels >120 mcg/dL Concurrent use of potent cytochrome inducer or inhibitor with documented interaction with rosuvastatin Pregnant and nursing females . Hypersensitivity to rosuvastatin Treatment - Drugs Intervention group: Patients will receive rosuvastatin once daily for a period of 12 weeks Prevalence of genetic polymorphism of rosuvastatin transporter genes SLCO1B3 and ABCG2 for their variant alleles i.e. SLCOIB3 334T >G (rs4149117), 699 G>A (rs7311358) and ABCG2 421 C>A (rs2231142), 34G >A (rs2231137). Timepoint: After 12 weeks of intervention with rosuvastatin drug. Method of measurement: Polymerase Chain Reaction-Restriction Fragment Length Polymorphism (PCR-RFLP) and Allele Specific Polymerase Chain Reaction (AS-PCR). Plasma rosuvastatin levels. Timepoint: After 12 weeks of intervention with rosuvastatin. Method of measurement: High Performance Liquid Chromatography (HPLC). Impact of polymorphic alleles of rosuvastatin transporter genes on biochemical parameters like Lipid Profile ( TC, LDL-c, HDL-c, TG and VLDL) ii. Serum Creatine Phospho Kinase (CPK) iii. Liver Function Tests iv. Renal Function Tests v. C-Reactive Protein (CRP). Timepoint: After 12 weeks of intervention with rosuvastatin. Method of measurement: Biochemical analysis. National University of Medical Sciences (NUMS) Rawalpindi Approved 2022-08-25 Ethical Review Committee of Army Medical College (AMC) Rawalpindi B-342/15 street No:3 Lane No:4 Peshawar Road Rawalpindi Rawalpindi Punjab Pakistan