Study on Rosuvastatin+Ezetimibe and Rosuvastatin for LDL-C Goal in Patients With Recent Ischemic Stroke

NCT03993236 | Completed Phase 4

• 1 other identifier: ROSETTA-Stroke
• Study Type: interventional
• Target: 584
• Locations: 1 country
• Sites: 12

Brief Summary

A randomized clinical trial for the comparison of the efficacy and safety of moderate-intensity rosuvastatin plus ezetimibe versus high-intensity rosuvastatin for target LDL-C goal achievement in patients with recent ischemic stroke

Conditions

Stroke, Ischemic

Keywords

Stroke, Ischemic; Rosuvastatin; Ezetimibe

Outcome Measures

Primary Outcomes (1)

• The percentage of subjects with LDL-C decreased more than 50% at 90days (±14 days) compared to Baseline

  The percentage of subjects with LDL-C decreased more than 50% at 90days (±14 days) compared to Baseline

  Baseline, Visit 4(Day 90)

Secondary Outcomes (10)

• Percentage of subjects with LDL-C less than 70 mg/dL at 90 days(±14 days)

  Baseline, Visit 4(Day 90)

• The percentage of subjects with LDL-C decreased more than or less than 70 mg/dL at 90 days(±14 days)

  Baseline, Visit 4(Day 90)

• The decrement of LDL-C at 90 days (±14 days) compared to baseline LDL-C (absolute difference and change)

  Baseline, Visit 4(Day 90)

• The percentage of subjects achieved multiple lipid level (Total-C < 200mg/dL, LDL-C < 70mg/dL and triglyceride < 150mg /dL)

  Baseline, Visit 4(Day 90)

• Cardiovascular event rates including stroke (ischemic or hemorrhagic), coronary artery(myocardial infarction or coronary vascular reperfusion) and death related to vascular disease.

  Baseline to Visit 4(up to 90 days)

Study Arms (2)

Rosuvastatin/Ezetimibe 10/10mg

EXPERIMENTAL

The experimental group is orally administered with rosuvastatin 10 mg plus ezetimibe 10 mg combination once daily for 90 days.

Drug: Experimental: Rosuvastatin/Ezetimibe 10

Rosuvastatin 20mg

ACTIVE COMPARATOR

The comparator group is orally administered with rosuvastatin 20 mg single agent once daily for 90 days

Drug: Active Comparator: Rosuvastatin 20mg

Interventions

Experimental: Rosuvastatin/Ezetimibe 10 DRUG

* Rosuvastatin/Ezetimibe 10/10mg * orally administered once daily for 90 days

Also known as: Rosuzet tab 10/10 mg

Rosuvastatin/Ezetimibe 10/10mg

Active Comparator: Rosuvastatin 20mg DRUG

* Rosuvastatin 20mg * orally administered once daily for 90 days

Also known as: Suvast tab 20mg

Rosuvastatin 20mg

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with recent ischemic stroke who meet both 1) and 2) criteria below. 1) Patients with acute ischemic stroke confirmed by DWI(diffusion-weighted imaging)
• This is satisfied by meeting at least one of the following two criteria:
• Patients who sustained stroke symptoms for more than 24 hours and had acute ischemic lesions on DWI.
• Patients with acute ischemic lesions in DWI who had improved symptoms within 24 hours.
• \) Patients with ischemic stroke within 90 days.
• Statin therapy indicated according to the recommendations of the 2014 American Heart Association/American Stroke Association guidelines.
• This is accomplished by meeting at least one of the following three criteria:
• Patients with ischemic stroke due to arteriosclerosis and LDL-C ≥ 100 mg / dL. (Class I; Level of Evidence B)
• Patients with ischemic stroke due to arteriosclerosis and LDL-C \<100 mg / dL. (Class I; Level of Evidence C)
• Patients who require statin therapy due to other associated atherosclerotic cardiovascular disease. (Class I; Level of Evidence A).
• Patients without statin dose within 28 days before ischemic stroke.
• Patients who measured baseline LDL-C levels after an ischemic stroke. This is satisfied by meeting at least one of the following two criteria:
• Patients who had a baseline LDL-C level before the onset of a recent ischemic stroke and started statin therapy.
• Patients hospitalized with acute ischemic stroke who had baseline LDL-C levels after initiation of statin therapy should meet both of the following conditions:
• Patients with LDL-C levels measured within 3 days after initiation of statin therapy

You may not qualify if:

• Planned vascular intervention before the end of trial
• Significant hepatic dysfunction (Aspartate Aminotransferase or Alanine Aminotransferase \>120 IU/L)
• Allergy or contraindication to rosuvastatin or ezetimibe
• Alcohol or drug addiction
• Pregnancy or breast-feeding
• Severe anemia: Hb level \<10 g/dL for men and \<9 g/dL for women
• Bleeding diathesis: platelet count \<100,000/μl or prothrombin time International Normalized Ratio \> 1·7
• Inability or unwillingness to comply with study-related procedures
• Employees of the investigator or study center, with direct involvement in the current study
• Women unwilling to continue contraception during the study period
• Participation in other clinical trials within three-month
• Malignancy or other serious medical conditions with a life expectancy \<6 months
• Treatment with protease inhibitors or cyclosporine
• Patients with severe renal impairment (creatinine clearance \<30 mL / min)
• Other reasons for ineligibility judged by investigators

Sponsors & Collaborators

• Keun-Sik Hong: lead
• Ewha Womans University Seoul Hospital: collaborator
• Severance Hospital: collaborator
• Korea University Ansan Hospital: collaborator
• Korea University Guro Hospital: collaborator
• Myongji Hospital: collaborator
• Seoul St. Mary's Hospital: collaborator
• Samsung Medical Center: collaborator
• Seoul National University Hospital: collaborator
• Chung-Ang University Hosptial, Chung-Ang University College of Medicine: collaborator
• Hallym University Medical Center: collaborator
• Kyunghee University Medical Center: collaborator
• Inje University Ilsan Paik Hospital: collaborator

Study Sites (12)

Korea University Ansan Hospital

Ansan-si, Gyeonggi-do, South Korea

Location

Hallym University Medical Center

Anyang-si, Gyeonggi-do, South Korea

Location

Myongji Hospital

Goyang-si, Gyeonggi-do, South Korea

Location

Inje University Ilsan Paik Hospital

Ilsan, Gyeonggi-do, South Korea

Location

Chung-Ang University Hopital

Seoul, South Korea

Location

Ewha Womans University Seoul hospital

Seoul, South Korea

Location

Korea University Guro Hospital

Seoul, South Korea

Location

Kyung-Hee University Medical Center

Seoul, South Korea

Location

Samsung Medical Center, Sungkyunkwan University School of Medicine

Seoul, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

Seoul St Mary's Hospital

Seoul, South Korea

Location

Severance Hospital, Yonsei University Health System

Seoul, South Korea

Location

Related Publications (1)

• Hong KS, Bang OY, Park JH, Jung JM, Lee SH, Song TJ, Nam HS, Park HK, Jung KH, Heo SH, Koo J, Yu KH, Park KY, Kim CK, Park HK, Lee J, Lee J, Seo WK. Moderate-Intensity Rosuvastatin Plus Ezetimibe Versus High-Intensity Rosuvastatin for Target Low-Density Lipoprotein Cholesterol Goal Achievement in Patients With Recent Ischemic Stroke: A Randomized Controlled Trial. J Stroke. 2023 May;25(2):242-250. doi: 10.5853/jos.2022.02957. Epub 2023 Apr 11.

  PMID: 37032475 RESULT

Related Links

• publication

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Keun-Sik Hong, MD., PhD.

  Department of Neurology, Inje University Ilsan Paik Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 17, 2019
• First Posted: June 20, 2019
• Study Start: September 9, 2019
• Primary Completion: September 27, 2021
• Study Completion: September 27, 2021
• Last Updated: October 3, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (12)