Clinical trial NCT05910476: Comparative Study of Rosuvastatin/Ezetimib 20/10 mg and Atovastatin/Ezetimib 40/10 mg (TOLERANT Trial)
Official title: A Randomized comparaTive Study Of Rosuvastatin/Ezetimibe 20/10mg and Atorvastatin/Ezetimibe 40/10mg in Patients With Coronary Artery Drug eLuting stEnt Implantation Requiring High-dose stAtin/Ezetimibe combiNaTion Therapy: TOLERANT Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Coronary Artery Disease
Dyslipidemias
Lead sponsor: Yonsei University
Sponsor class: OTHER
Collaborators: name: dotter
First posted: 2023-06-18
Enrollment: 200
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: the investigators would like to compare the differences between roschvastin and atovastatin in patients who require high-dose statin/ejetimib to undergo a new generation of drug elution stent implantation for cardiovascular disease and maintain LDL cholesterol below 55 mg/dL.

Detailed description: Death from vascular disease accounts for about one-third of all causes of death. Important regulatory factors in cardiovascular disease include dyslipidemia, high blood pressure, and diabetes, and keeping LDL cholesterol low among dyslipidemia levels, especially after cardiovascular stent treatment, is an essential factor to prevent another event in the future. Statin is currently the most widely used LDL cholesterol control drug with multifunctional effects such as controlling inflammatory reactions, controlling the movement and proliferation of vascular smooth muscle cells, and inhibiting the production of blood clots in addition to LDL cholesterol control.In addition, in several clinical studies, statins have shown many effects in primary and secondary prevention of cardiovascular disease, and several studies have been published that lower LDL cholesterol results in more benefits. Based on these findings, the 2016 European Heart Association (ESC), 2018 American Heart Association (ACC), and most recently changed 2022 Korean guidelines recommend controlling LDL cholesterol to \<55mg/dL for patients with coronary artery disease. However, high-dose statins alone are still difficult to maintain for a long time due to increased liver levels, diabetes, and muscle pain, and recently, a drug that lowers LDL cholesterol has been developed in the small intestine called Ezetimib and is widely used in combination with statins in actual clinical trials. In fact, the RACING trial published in LANCET for domestic patients reported that the combination of moderate-intensity statins (Rosuvastatin 10mg) and ezetimib had fewer side effects for three years and better compliance, resulting in a better rate of maintaining LDL cholesterol at 70mg/dL or less than high-intensity statins alone. However, in this study, the rate at which LDL cholesterol remained below 55 mg/dL after one year was only 42% for moderate statins/esetimibe and 25% for high-intensity statins, and remained similar for three years. Therefore, high-intensity statins and ezetimibes may be essential treatments to reduce LDL cholesterol to less than 55 mg/dL and more than 50% under the current new guidelines. High-strength statins usually refer to more than 40 mg of atovastatin and 20 mg of Rosuvastatin, and drugs that combine ezetimibe with these high-strength statins are currently widely used to lower LDL cholesterol to 55 mg/dL or less if there are no special side effects in clinical practice, but research on compliance is very insufficient. This study aims to observe the rate of discontinuation or intolerance in patients taking Rosuvastatin/Ezetimib 20/10mg and Atovastatin/Ezetimib 40/10mg, with no previous comparison, RACING trial reported a 5% rate of discontinuation at rosuvastain 20mg administered, and atovatin/10mg/10mg. Referring to On the use of a pilot sample for sample size determination. the hospital conducts about 60 PCI cases a month, and about 1/5 of them are expected to be able to enroll 100 patients per group for about two years to conduct a total of 200 patients.

Eligibility criteria: Inclusion Criteria:

1. 19 years of age or older
2. Patients who underwent a new generation of drug elution stent implantation for cardiovascular disease

Exclusion Criteria:

1. LDL cholesterol levels below 55 mg/dL without statin treatment
2. Serum AST/ALT with an acute liver disease within a month or a normal upper limit that is not continuously explained
3. Allergies or overreactions to statins
4. Estimated Dawn of Less than 1 Year
5. If it is determined that follow-up is not possible for more than one year
6. Pregnancy

Primary outcomes:
measure: Percentage of statins changed
timeFrame: 12 months
measure: Rate at which LDL cholesterol remains below 55 mg/dL
timeFrame: 12 months
Secondary outcomes:
measure: The rate at which LDL cholesterol is maintained at 55 mg/dL in the blood test after a month
timeFrame: 1 months
measure: Cardiovascular death
timeFrame: 12 months
measure: number of non-fatal myocardial infarction
timeFrame: 12 months
measure: number of non-fatal stroke
timeFrame: 12 months
measure: number of coronary artery re-perfusion
timeFrame: 12 months
measure: number of Newly developed diabetes or difficulty in controlling sugar
timeFrame: 12 months
measure: occurrence of statin-related muscle symptoms requiring therapeutic or dose changes
timeFrame: 12 months
measure: Increased muscle enzyme aberration
timeFrame: 12 months
measure: Elevated liver enzyme levels
timeFrame: 12 months
measure: Elevated serum creatine levels
timeFrame: 12 months
measure: number of Major bleeding
timeFrame: 12 months
measure: number of people who stopped taking the drug
timeFrame: 12 months
Other outcomes:
Locations:
city: Yongin
country: Korea, Republic of
facility: Yongin Severance Hospital
state: Gyeonggi-do
Study officials:
affiliation: Yonsei University
name: Yongcheol Kim, MD
role: STUDY_DIRECTOR
References: