Effects of Ezetimibe Combination Therapy for Patients With Atherosclerotic Cardiovascular Disease; Randomized Comparison of LDL-cholesterol Targeting <70 Versus <55mg/dL; Ez-PAVE Trial

NARecruitingINTERVENTIONAL
Enrollment

3,048

Participants

Timeline

Start Date

January 15, 2021

Primary Completion Date

September 30, 2025

Study Completion Date

September 30, 2025

Conditions
Atherosclerotic Cardiovascular Disease
Interventions
DRUG

Ezetimibe/Statin Combination therarpy (ezetimibe plus rosuvastatin)

"For statin naive patients, patients would initially receive Ezetimibe 10mg plus Rosuvastatin 10 or 20 mg.~For non-statin naive patients, regimens are to be changed to the equivalent dose of ezetimibe+rosuvastatin combination in case of already achieved LDL-cholesterol target (\<55 mg/dL) and to be dosed up than the equivalent dose of study drugs in case of not yet achieved LDL-cholesterol target."

DRUG

Statin monotherapy (rosuvastatin or atorvastatin)

"For statin naive patients, patients would initially receive Rosuvastatin 20mg or Atorvastatin 40 or 80 mg.~For non-statin native patients, regimens are to be change to equivalent dose of atorvastatin or rosuvastatin in case of already achieved LDL-cholesterol target (\<55 mg/dL) and to be dosed up than the equivalent dose of study drugs in case of not yet achieved LDL-cholesterol target."

DRUG

Ezetimibe/Statin Combination therarpy (ezetimibe plus rosuvastatin)

"For statin naive patients, patients would initially receive Ezetimibe 10mg plus Rosuvastatin 5 or 10mg.~For non-statin naive patients, regimens are to be changed to the equivalent dose of ezetimibe+rosuvastatin combination in case of already achieved LDL-cholesterol target (\<70 mg/dL) and to be dosed up than the equivalent dose of study drugs in case of not yet achieved LDL-cholesterol target."

DRUG

Statin monotherapy (rosuvastatin or atorvastatin)

For statin naive patients, patients would initially receive Rosuvastatin 10 or 20mg or Atorvastatin 20 or 40mg. For non-statin native patients, regimens are to be change to equivalent dose of atorvastatin or rosuvastatin in case of already achieved LDL-cholesterol target (\<70 mg/dL) and to be dosed up than the equivalent dose of study drugs in case of not yet achieved LDL-cholesterol target.

Trial Locations (1)

Unknown

RECRUITING

Division of Cardiology, Yonsei Cardiovascular Hospital, Yonsei University College of Medicine, Seoul

All Listed Sponsors
lead

Yonsei University

OTHER