Clinical trials: HMG COA Reductase Inhibitor Adverse Reaction
Hypercholesterolemia, Atherosclerotic Cardiovascular Disease
Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) in Patients With Hyperlipidemia and Statin Intolerant
The purpose of this study is to determine if bempedoic acid (ETC-1002) is effective and safe versus placebo in patients with elevated LDL cholesterol and who are statin-intolerant.
- Conditions
- Hypercholesterolemia, Atherosclerotic Cardiovascular Disease, Statin Adverse Reaction
- Trial name
- CLEAR Serenity (NCT02988115)
- Testing
- bempedoic acid
- Where
- 67 sites in United States, Canada
- Volunteers
- 345 people
- Sponsor
- Esperion Therapeutics, Inc.
Adherence, Medication, Statin Adverse Reaction
Medicines Gaps Study
The adherence project aims to understand adherence rates and barriers to Direct oral anticoagulants (DOACs) and statins and improve awareness of healthcare professionals on adherence across Leeds.
- Conditions
- Adherence, Medication, Statin Adverse Reaction, Anticoagulant Adverse Reaction
- Trial name
- MeGa (NCT05332158)
- Testing
- Questionnaires to report barriers to medication adherence
- Where
- United Kingdom
- Volunteers
- 3,000 people
- Sponsor
- The Leeds Teaching Hospitals NHS Trust
Pain, Weakness
Clinical Trial of CoQ10 for Mild-to-Moderate Statin-Associated Muscle Symptoms
This study will evaluate whether a dietary supplement, coenzyme Q10 (CoQ10), will improve muscle symptoms, such as muscle aches, pains, cramps, and/or weakness, which are experienced by some individuals who use statin medications.
- Conditions
- Pain, Weakness, Cramps, Myalgia or Myositis Nos
- Trial name
- NCT01032993
- Testing
- Coenzyme Q10
- Where
- United States
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- Catherine Buettner
Statin Therapy, Statin Adverse Reaction
DESIFOR-EXPAND (MHIF)
The DESIFOR pilot study was conducted to determine the feasibility of utilizing an n-of-1 trial to facilitate tolerance of unblinded rosuvastatin in patients with prior statin intolerance
- Conditions
- Statin Therapy, Statin Adverse Reaction, Statin
- Trial name
- NCT06804980
- Testing
- Rosuvastatin (Crestor)
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Minneapolis Heart Institute Foundation
Statin Adverse Reaction, Statin-induced Myopathy
Metabolic and Mitochondrial Changes in Statin-Induced Myopathy
The goal of this observational study is to learn whether statin-related muscle symptoms are linked to problems in fat metabolism in muscle cells, specifically involving acylcarnitines, in adults taking or not taking statins.
- Trial name
- NCT07511686
- Testing
- Blood sampling and laboratory assessment, Muscle biopsy
- Where
- Latvia
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Riga Stradins University
HMG COA Reductase Inhibitor Adverse Reaction
Muscle-Related Side Effects of Statins: Functional Impact, Mechanisms, and Potential Relief With Vitamin D Supplementation
This proposal will explore muscle function (strength and endurance) in men and women suffering from statin-induced muscle symptoms. The mechanisms responsible for these muscle symptoms will be explored.
- Trial name
- NCT01493648
- Testing
- Vitamin D
- Where
- Canada
- Volunteers
- 78 people, healthy volunteers welcome
- Sponsor
- CHU de Quebec-Universite Laval
Statin Adverse Reaction, Skeletal Myopathy
NIRS to Diagnose SAMS
This proposal seeks to determine whether near infrared spectroscopy (NIRS) can differentiate between patients with confirmed SAMS and those with non-specific muscle complaints.
- Trial name
- NCT03653663
- Testing
- Simvastatin 20 mg
- Where
- 2 sites in United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Hartford Hospital
Statin Adverse Reaction
MUscle Side-Effects of Atorvastatin in Coronary Patients (MUSE) -Follow-up Study
Statins are cornerstone treatment in secondary cardiovascular disease (CVD) prevention. Today, statin non-adherence (patients not taking their prescribed drug) remains a major public health concern, leading to adverse outcomes in…
- Trial name
- NCT04453735
- Testing
- Atorvastatin mylan 40 Mg Oral Tablet
- Where
- 2 sites in Norway
- Volunteers
- 27 people
- Sponsor
- Vestre Viken Hospital Trust
Diabetes Mellitus, Type 2, Dyslipidemia Associated With Type II Diabetes Mellitus
Effects of High Intensity Statin Therapy on Steroid Hormones and Vitamin D in Type 2 Diabetic Men
The aim of the study was to assess the effect of high intensity statin therapy on testicular and adrenal steroids and vitamin D levels in type 2 diabetes males.It is a prospective study, conducted between march 2021 and July…
- Conditions
- Diabetes Mellitus, Type 2, Dyslipidemia Associated With Type II Diabetes Mellitus, Statin Adverse Reaction, Hypogonadism, Male
- Trial name
- NCT05806723
- Testing
- Atorvastatin 40 Mg Oral Tablet
- Where
- Tunisia
- Volunteers
- 104 people
- Sponsor
- Hopital La Rabta
Myopathy, HMG COA Reductase Inhibitor Adverse Reaction
Evaluation of Ubiquinol on Mitochondrial Oxidative Capacity in Statin Patients Using 31PMRS
It is our primary hypothesis that statin drugs impair skeletal muscle mitochondrial function and that ubiquinol (the reduced active form of CoQ10) supplementation will block impairment of PCr recovery kinetics in patients using…
- Conditions
- Myopathy, HMG COA Reductase Inhibitor Adverse Reaction, Hypercholesterolemia
- Trial name
- NCT01702987
- Testing
- ubiquinol, statin
- Where
- United States
- Volunteers
- 22 people
- Sponsor
- Beth Israel Deaconess Medical Center
Cardiovascular Diseases, HMG COA Reductase Inhibitor Adverse Reaction
Physical Activity Levels and Statin Therapy
Rationale: Combining statin treatment and physical activity is very effective for the prevention of cardiovascular diseases. Statins are well-tolerated by most patients, but may cause statin-associated muscle symptoms (SAMS).
- Conditions
- Cardiovascular Diseases, HMG COA Reductase Inhibitor Adverse Reaction, Muscle Pain
- Trial name
- NCT05625945
- Testing
- Physical activity monitoring
- Where
- Netherlands
- Volunteers
- 196 people
- Sponsor
- Radboud University Medical Center
Dyslipidemias, Statin Adverse Reaction
Efficacy and Safety of Bempedoic Acid in Association With Anti-PCSK9 and Ezetimibe in Statin-intolerant Patients
Statin intolerance occurs in up to 15-20% of treated patients. The combined use of Proprotein Convertase Subtilisin/Kexin type 9 (PCSK9) inhibitors with ezetimibe is commonly performed in these patients, and has been associated…
- Conditions
- Dyslipidemias, Statin Adverse Reaction, Cardiovascular Diseases, Lipid Metabolism Disorders
- Trial name
- BESAFE (NCT06381947)
- Testing
- Lipid-lowering therapy combination with PCSK9 inhibitors, bempedoic acid and ezetimibe, Lipid-lowering therapy combination with PCSK9 inhibitors and ezetimibe
- Volunteers
- 130 people
- Sponsor
- University of Salerno
Statin Adverse Reaction
Hepatic Safety of Statin Use in Neurology Inpatients
This research employs a cross-sectional study and a retrospective cohort study to analyze the liver safety of statin use among inpatients in the neurology department in China from different perspectives.
- Trial name
- NCT06592196
- Testing
- stain
- Where
- China
- Volunteers
- 2,000 people
- Sponsor
- Shanghai Yueyang Integrated Medicine Hospital
Myopathy
SAPhIRE Statin Adverse Drug Reaction
To find out the pharmacokinetic and genetic risk factors involved in muscular side effects (myalgia) associated with statin therapy.
- Trial name
- STATIN (NCT03042286)
- Where
- Singapore
- Volunteers
- 1,500 people
- Sponsor
- National Heart Centre Singapore
Statin Adverse Reaction
Statin Intolerance in Patients With Myocardial Infarction
Patients with acute coronary syndrome (MI, NSTEMI, USAP) will be included. They will be screened for statin intolernace for 6 months.
- Trial name
- NCT04069598
- Testing
- Statin intolerance test
- Where
- 4 sites in Turkey (Türkiye)
- Volunteers
- 600 people
- Sponsor
- Turkish Society of Cardiology
Statin Adverse Reaction
Exercise Intensity and Muscle Recovery in Statin Users
This study aims to investigate how different types and intensities of exercise affect muscle recovery in individuals taking statin medications compared to healthy controls.
- Trial name
- STN-EX (NCT07563452)
- Testing
- Dose-Escalation Exercise Protocol
- Where
- Austria
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Raffaele Mazzolari
HMG COA Reductase Inhibitor Adverse Reaction
Vitamin D Replacement in Statin-Induced Myopathy
Pretreating people with replacement doses of vitamin D will allow them to tolerate Statin medications that have caused muscle pain for them in the past.
- Trial name
- NCT01400009
- Testing
- Vitamin D (Cholecalciferol )
- Where
- Canada
- Volunteers
- healthy volunteers welcome
- Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
Statin Adverse Reaction
The Association of Statins on Cardiorespiratory Fitness and Exercise Adaptation
Statins are part of one of the largest groups of drugs prescribed worldwide used in the treatment of dyslipidemia. Despite the good therapeutic results of statins and their good tolerance on the part of patients, some adverse…
- Trial name
- NCT04986241
- Testing
- Statin, Physical activity, Sedentary
- Where
- Brazil
- Volunteers
- 18,557 people, healthy volunteers welcome
- Sponsor
- University of Sao Paulo General Hospital
Hypercholesterolemia, Atherosclerosis
Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) as Add-on to Ezetimibe Therapy in Patients With Elevated LDL-C (CLEAR Tranquility)
The purpose of this study is to determine if bempedoic acid (ETC-1002) added-on to ezetimibe therapy is effective and safe versus placebo in patients with elevated LDL cholesterol.
- Conditions
- Hypercholesterolemia, Atherosclerosis, Statin Adverse Reaction
- Trial name
- NCT03001076
- Testing
- Bempedoic acid, Ezetimibe
- Where
- United States
- Volunteers
- 269 people
- Sponsor
- Esperion Therapeutics, Inc.
Cardiovascular Diseases, Dyslipidemias
Efficacy, Safety and Cost-efficacy of a Pre-emptive Genotyping Strategy in Patients Receiving Statins
This is a Phase IV multicentre adaptive single-blinded randomized clinical trial if preemptively genotyping populations at risk of cardiovascular disease susceptible of receiving high or moderate doses of statin therapy is…
- Conditions
- Cardiovascular Diseases, Dyslipidemias, Statin Adverse Reaction, Pharmacogenic Myopathy
- Trial name
- PREVESTATGx (NCT06262685)
- Testing
- Preemptive pharmacogenetic atorvastatin dose based on CPIC guidelines, Preemptive pharmacogenetic simvastatin dose based on CPIC guidelines, Preemptive pharmacogenetic pitavastatin dose based on CPIC guidelines
- Where
- Spain
- Volunteers
- 216 people
- Sponsor
- Instituto de Investigación Hospital Universitario La Paz