Clinical trials: Statin Adverse Reaction
Cardiovascular Risk Factor, Cardiovascular Diseases
The DEtermining Statin Intolerance FOr Rosuvastatin (DESIFOR) Trial
This study will enroll patients who previously were not able to tolerate being on a statin medication due to muscle-related side effects.
- Conditions
- Cardiovascular Risk Factor, Cardiovascular Diseases, Adverse Effect
- Trial name
- DESIFOR (NCT03889314)
- Testing
- Rosuvastatin 20mg
- Where
- United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Minneapolis Heart Institute Foundation
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
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.
Parkinson Disease, Dyskinesia, Drug-Induced
Preventing Levodopa Induced Dyskinesia in Parkinson's Disease With HMG-CoA Reductase Inhibitors
In this study, the investigators will examine the association of statin use and dyskinesia in a convenience sample Parkinson's disease patients in the Veterans Administration Health Care System.
- Trial name
- STAT-PD (NCT04064294)
- Testing
- Intravenous Infusion
- Where
- 3 sites in United States
- Volunteers
- 93 people
- Sponsor
- VA Office of Research and Development
Pharmacogenetics, Drug-Related Side Effects and Adverse Reactions
Pharmacogenomics in Prediction of Cardiovascular Drugs Adverse Reaction
The research is planned as a prospective nested case-control study. The plan is to recruit about 1,200 consecutive subjects whose pharmacotherapy involves the drug(s) of interest within 4.5 years.
- Conditions
- Pharmacogenetics, Drug-Related Side Effects and Adverse Reactions, Cardiovascular Drugs
- Trial name
- NCT05307718
- Testing
- Oral Anticoagulant, Direct-Acting
- Where
- Croatia
- Volunteers
- 1,200 people
- Sponsor
- Clinical Hospital Centre Zagreb
Statin Adverse Reaction
MUscle Side-Effects of Atorvastatin in Coronary Patients
The study aims to estimate the effect of atorvastatin on muscular symptom intensity in coronary patients with subjective statin-associated muscle symptoms (SAMS) and to determine the association with blood levels of atorvastatin…
- Trial name
- MUSE (NCT03874156)
- Testing
- Atorvastatin 40mg
- Where
- 2 sites in Norway
- Volunteers
- 77 people
- Sponsor
- Vestre Viken Hospital Trust
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
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
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
Solid Tumors, Ototoxicity
Statins Effect on Incidence of Side Effects of Platinum Based Chemotherapy
Platinum based chemotherapy (mainly Cisplatin) is known to cause a variety of adverse effects, including Ototoxicity and nephrotoxicity.
- Trial name
- NCT06553157
- Testing
- Statin
- Where
- Egypt
- Volunteers
- 56 people
- Sponsor
- Minia University
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
Doxorubicin Induced Cardiomyopathy
Role of Statin Therapy in Prevention of Anthracycline-Induced Cardiotoxicity
This study aims at evaluating the role of Atorvastatin in prevention of Anthracycline induced cardiotoxicity
- Trial name
- NCT05792293
- Testing
- Atorvastatin 40 Mg Oral Tablet
- Where
- Egypt
- Volunteers
- 100 people
- Sponsor
- Ain Shams University
Muscle Cramp, Ache
7T Magnetic Resonance Spectroscopy and Skeletal Muscle Biopsy Findings in Statin Associated Adverse Muscle Events
Over 40 million Americans take statins to reduce their risk of atherosclerotic cardiovascular disease (ASCVD). Unfortunately, 10 to 20% stop taking them due to statin-associated muscle symptoms (e.g.
- Conditions
- Muscle Cramp, Ache, Weakness, Muscle, Statin Adverse Reaction
- Trial name
- NCT04507373
- Testing
- Simvastatin 40mg
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- University of Texas Southwestern 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
Cardiovascular Diseases, HMG COA Reductase Inhibitor Adverse Reaction
Exercise-induced Muscle Damage in Statin Users
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) and…
- Conditions
- Cardiovascular Diseases, HMG COA Reductase Inhibitor Adverse Reaction, Muscle Damage
- Trial name
- NCT05011643
- Testing
- Moderate-intensity exercise
- Where
- Netherlands
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Radboud University Medical Center
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
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
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
Cardiac Toxicity, Early-stage Breast Cancer
Statins for Reduction of Cardiac Toxicity in Patients Receiving HER2 Targeted
This study proposes that the addition of statins reduces the treatment delays or early discontinuations secondary to cardiotoxicity in patients with Stage I-III HER2 positive breast being treated with anti-HER2 therapy.
- Trial name
- NCT05559164
- Testing
- Lipitor 40mg Tablet
- Where
- 10 sites in United States
- Volunteers
- 60 people
- Sponsor
- Rutgers, The State University of New Jersey
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