Randomized Controlled Trial of Moderate-Intensity Rosuvastatin With Ezetimibe Combination Therapy… (NCT03169985) | Clinical Trial Compass
Active — Not RecruitingPhase 4
Randomized Controlled Trial of Moderate-Intensity Rosuvastatin With Ezetimibe Combination Therapy Versus High-Intensity Rosuvastatin on Progression of Coronary Atherosclerotic Plaque
South Korea280 participantsStarted 2017-07-12
Plain-language summary
The aim of this prospective, open-label, randomized, single center study is to compare the effect of usual dose rosuvastatin plus ezetimibe and high-dose rosuvastatin on modifying atherosclerotic plaque.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Subject must be at least 19 years of age
* Subject with suspected ischemic heart disease undergoing coronary angiography and have intermediate coronary artery stenosis (30-70% by visual estimation) whose revascularization was deferred based on invasive physiologic assessment using fractional flow reserve (\>0.80) or intravascular ultrasound (minimum lumen area\> 4mm2)
* Subject can verbally confirm understandings of risks, benefits and treatment alternatives of receiving statin or ezetimibe and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure.
Exclusion Criteria:
* Subject has calculated creatinine clearance \<30 mL/min or dialysis within 30 days.
* Subject has active liver disease or persistent unexplained serum transaminase elevations (x2 x upper limit of normal \[ULN\]).
* Subject requires the following concomitant medications: cyclosporine, danazol, niacin, fibrates as concomitant medications
* Subject requires any of the potent CYP3A4 inhibitors, itraconazole, ketoconazole, erythromycin, clarithromycin, and telithromycin, HIV protease inhibitors, nefazodone, probucol, resins, and any investigational drugs.
* Subject has an allergy/sensitivity to any statin, ezetimibe, and/or their excipients.
* Subject with history of myopathy or family history of myopathy
* Untreated hypothyroidism
* Subject has a history of alcohol and/or drug abuse.
* Subject is a pregnant or lactating w…
What they're measuring
1
Change in percent atheroma volume(PAV) in non-culprit lesions
Timeframe: 12 months after index coronary angiography(CAG)