Clinical trials: Statin Intolerance
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.
Hyperlipidemia
Randomized Clinical Trial of Bococizumab (PF-04950615; RN316) in Subjects Who Are Intolerant to Statins
This study is a multicenter, double blinded, active and placebo controlled randomized clinical trial to demonstrate a superior lipid lowering effect of Bococizumab (PF-04950615; RN316) compared to placebo in subjects who are…
- Trial name
- SPIRE-SI (NCT02135029)
- Testing
- Bococizumab (PF-04950615;RN316), Atorvastatin
- Where
- 40 sites in United States, Canada
- Volunteers
- 184 people
- Sponsor
- Pfizer
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
Hypercholesterolemia
A Phase III Confirmatory Study of K-877 (Pemafibrate) in Patients With Hypercholesterolemia and Statin Intolerance
To investigate the efficacy and safety of K-877 Extended Release 0.2 mg/day or 0.4 mg/day for 12 weeks in patients with Statin Intolerant* Hypercholesterolemia,using placebo as a controll.
- Trial name
- NCT05923281
- Testing
- K-877 0.2 mg/day (once daily), K-877 0.4 mg/day (once daily)
- Where
- 22 sites in Japan
- Volunteers
- 71 people
- Sponsor
- Kowa Company, Ltd.
Hyperlipidemia, Coronary Artery Disease
Lipid Lowering in Patients With Statin Intolerance
This study will attempt to further validate a clinical treatment plan to lower LDL values using non-prescription supplements combined with a lifestyle change and education program which could represent an alternative approach to…
- Trial name
- NCT00405769
- Testing
- red yeast rice
- Where
- United States
- Volunteers
- 64 people
- Sponsor
- Chestnut Hill Health System
Diabetes Mellitus, Glucose Intolerance
Japan Prevention Trial of Diabetes by Pitavastatin in Patients With Impaired Glucose Tolerance (J-PREDICT)
The purpose of this study is to evaluate the effects of pitavastatin for preventing diabetes in a population with impaired glucose tolerance.
- Trial name
- NCT00301392
- Testing
- life-style intervention, Life style interventions plus concomitant use of pitavastatin.
- Where
- Japan
- Volunteers
- 1,240 people
- Sponsor
- Tokyo University
Dyslipidemias
Statin-Intolerance Registry
The Statin-Intolerance Registry will characterize the patient population suffering from statin-intolerance which is a frequent but incompletely understood patient condition with important clinical implications for atherosclerotic…
- Trial name
- SIR (NCT04975594)
- Where
- Germany
- Volunteers
- 1,000 people
- Sponsor
- University of Leipzig
Hyperlipidemia
Red Yeast Rice and Phytosterols In Statin Intolerance
Red yeast rice may be useful to lower cholesterol, especially in a population of patients who cannot tolerate traditional therapy with statins.
- Trial name
- NCT00897975
- Testing
- red yeast rice, phytosterol, therapeutic lifestyle program
- Where
- 2 sites in United States
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Chestnut Hill Health System
Drug Intolerance
Statin Immune Study
Statins are widely used drugs to treat hypercholesterolaemia. In general, they are very safe drugs. However, up to one third of statin users can experience muscle symptoms, which are most commonly mild without any conventional…
- Trial name
- ImmunoStat (NCT02984293)
- Testing
- Atorvastatin
- Where
- United Kingdom
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- University of Dundee
Hypercholesterolemia, Statin-Associated Myopathy
Safety of Red Yeast Rice for High Cholesterol in Individuals With Statin Intolerance
This study will examine the effect of red yeast rice extract compared to pravastatin on muscle related complaints in individuals with high cholesterol who have previously been unable to tolerate statin medications due to muscle…
- Trial name
- NCT00639223
- Testing
- Red Yeast Rice, Pravastatin, Lifestyle modification program
- Where
- United States
- Volunteers
- 43 people
- Sponsor
- University of Pennsylvania
Coronary Artery Disease, Statin Adverse Reaction
Barriers to Optimal LDL-C Targets in Patients With Atherosclerotic Cardiovascular Disease
In the present cross-sectional observational study, the investigators aimed to: Evaluate the prevalence of achievement of LDL-C targets among a sample of Egyptian ASCVD patients.
- Conditions
- Coronary Artery Disease, Statin Adverse Reaction, LDL Level
- Trial name
- BOLT (NCT06897566)
- Testing
- Fasting lipid profile
- Where
- 2 sites in Egypt
- Volunteers
- 1,000 people
- Sponsor
- Cairo University
Statin Intolerance
Effects of Epicatechin on Statins for Mitochondrial Dysfunction and Impaired Exercise Capacity
The purpose of this study is to gain insight into the side-effects of statin consumption, and assess the ability of epicatechin (a compound in dark chocolate) to counteract or reverse these changes.
- Trial name
- NCT02490527
- Testing
- Pure epicatechin capsules (50mg), Simvastatin (40mg)
- Where
- United States
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- University of California, San Diego
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
Hyperlipidemia, Ursodeoxycholic Acid
Ursodeoxycholic Acid Attenuates Statin-Induced Impaired Glucose Tolerance
The purpose of this clinical trial is to understand whether the drug Ursodeoxycholic acid (UDCA) can prevent glucose intolerance in participants with hyperlipidemia who are taking statins. It will also assess the safety of UDCA.
- Conditions
- Hyperlipidemia, Ursodeoxycholic Acid, Statin Therapy, Glucose Intolerance
- Trial name
- URSTAR (NCT06684106)
- Testing
- Ursodeoxycholic acid (UDCA) 500 mg
- Where
- 2 sites in China
- Volunteers
- 128 people, healthy volunteers welcome
- Sponsor
- First Affiliated Hospital Xi'an Jiaotong University
Drug Interactions, Primary Prevention
LDL-C Optimization Using Inclisiran in Patients in Which Drug-Drug Interactions Limit LDL Lowering
Drug-drug interactions often limit statin optimization in a population of patients prescribed cytochrome P3A4 inhibitors, which include immunosuppressive agents, protease inhibitors, and antifungals.
- Conditions
- Drug Interactions, Primary Prevention, Cardiometabolic Syndrome, LDL-Cholersterol Lowering
- Trial name
- SOLVE-LDL-C (NCT06865885)
- Testing
- Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) in 1.5 mL
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- University of California, San Diego
Hypercholesterolemia, Atherosclerotic Cardiovascular Disease (ASCVD)
Dual PCSK9 Inhibition With Inclisiran and Alirocumab in Secondary Prevention
This study will evaluate the effectiveness and safety of combining two different types of PCSK9 inhibitors, inclisiran and alirocumab, in patients with high cardiovascular risk who are unable to tolerate statins.
- Trial name
- PCSK9-DUO (NCT07581808)
- Testing
- Inclisiran, Alirocumab
- Where
- Slovenia
- Volunteers
- 60 people
- Sponsor
- University Medical Centre Ljubljana
Hypercholesterolemia
A Study of the Efficacy and Safety of ETC-1002 in Participants With Statin Intolerance
This study will assess the Low-Density Lipoprotein-Cholesterol (LDL-C) lowering efficacy and safety of ETC-1002 versus placebo in participants with hypercholesterolemia and a history of statin intolerance.
- Trial name
- NCT01751984
- Testing
- ETC-1002
- Where
- 5 sites in United States
- Volunteers
- 56 people
- Sponsor
- Esperion Therapeutics, Inc.
Pre Diabetes, ASCVD
Comparison of Low-Intensity Statin Plus Ezetimibe Versus High-Intensity Statin Therapy on Risk of New-Onset Diabetes Mellitus (PROVE-DM)
This study is to evaluating the impact of low-intensity statin plus ezetimibe versus high-intensity statin therapy on risk of new-onset diabetes mellitus in patients with atherosclerotic cardiovascular disease who have…
- Trial name
- NCT05579626
- Testing
- high-intensity statin arm, low-intensity statin plus ezetimibe
- Where
- 31 sites in South Korea
- Volunteers
- 4,000 people
- Sponsor
- Seung-Whan Lee, M.D., Ph.D.