Condition or disease | Intervention/treatment | Phase |
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Stroke, Ischemic | Drug: Experimental: Rosuvastatin/Ezetimibe 10 Drug: Active Comparator: Rosuvastatin 20mg | Phase 4 |
The purpose of this study is to compare the efficiency and safety on the target LDL-C goal achievement between rosuvastatin 10 mg plus ezetimibe 10 mg (rosuvastatin/ezetimibe 10/10 mg) once daily versus rosuvastatin 20 mg once daily in patients with recent ischemic stroke.
The target LDL-C goal achievement rate in patients with recent ischemic stroke has not been well studied. In particular, no clinical studies have been conducted comparing the efficacy and safety of low-dose rosuvastatin plus ezetimibe with high-dose rosuvastatin single agent for achieving target LDL-C levels.
In this trial, the investigators aim to compare the efficacy of the target LDL-C achievement between rosuvastatin 10 mg plus ezetimibe 10 mg (rosuvastatin/ezetimibe 10/10 mg) and rosuvastatin 20 mg in patients with recent ischemic stroke.
For this trial, more than 292 patients (584 total) per group will be enrolled.
Subjects who were satisfied with the inclusion/exclusion criteria of this trial and who agreed to participate in the clinical trial in writing were randomly assigned to a 1:1 ratio in the experimental group (the low-dose combination of rosuvastatin plus ezetimibe) and comparator group (high-dose rosuvastatin).
The duration of administration of the drug for clinical trials is 90 days (±14 days), and the efficacy and safety evaluation parameters are compared with baseline.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 584 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Supportive Care |
Official Title: | Moderate-intensity Rosuvastatin Plus Ezetimibe Versus High-intensity Rosuvastatin for Target LDL-C Goal Achievement in Patients With Recent Ischemic Stroke: a Randomized Clinical Trial |
Actual Study Start Date : | September 9, 2019 |
Estimated Primary Completion Date : | November 12, 2020 |
Estimated Study Completion Date : | November 12, 2020 |
Arm | Intervention/treatment |
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Experimental: Rosuvastatin/Ezetimibe 10/10mg
The experimental group is orally administered with rosuvastatin 10 mg plus ezetimibe 10 mg combination once daily for 90 days.
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Drug: Experimental: Rosuvastatin/Ezetimibe 10
Other Name: Rosuzet tab 10/10 mg
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Active Comparator: Rosuvastatin 20mg
The comparator group is orally administered with rosuvastatin 20 mg single agent once daily for 90 days
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Drug: Active Comparator: Rosuvastatin 20mg
Other Name: Suvast tab 20mg
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Ages Eligible for Study: | 19 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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 with acute ischemic lesions in DWI who had improved symptoms within 24 hours.
2) 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 who measured baseline LDL-C levels after an ischemic stroke. This is satisfied by meeting at least one of the following two criteria:
Patients hospitalized with acute ischemic stroke who had baseline LDL-C levels after initiation of statin therapy should meet both of the following conditions:
Exclusion Criteria:
Contact: Keun-Sik Hong, MD., PhD. | 82-31-910-7277 | nrhks@paik.ac.kr |
Korea, Republic of | |
Korea University Ansan Hospital | Recruiting |
Ansan-Si, Gyeonggi-Do, Korea, Republic of | |
Contact: Jin-Man Jung, MD., PhD. sodium75@hanmail.net | |
Hallym University Medical Center | Recruiting |
Anyang-si, Gyeonggi-Do, Korea, Republic of | |
Contact: Mi-Sun Oh, MD., PhD. iyyar@hallym.ac.kr | |
Myongji Hospital | Recruiting |
Goyang-Si, Gyeonggi-Do, Korea, Republic of | |
Contact: Jong-Ho Park, MD., PhD. neurocraft.jhp@gmail.com | |
Inje University Ilsan Paik Hospital | Recruiting |
Ilsan, Gyeonggi-Do, Korea, Republic of | |
Contact: Keun-Sik Hong, MD, Phd 82-31-910-7277 nrhks@paik.ac.kr | |
Chung-Ang University Hopital | Not yet recruiting |
Seoul, Korea, Republic of | |
Contact: Kwang-Yeol Park, MD., PhD. sbaram1@cau.ac.kr | |
Ewha Womans University Seoul hospital | Recruiting |
Seoul, Korea, Republic of | |
Contact: Tae-Jin Song, MD., PhD. knstar@hanmail.net | |
Korea University Guro Hospital | Recruiting |
Seoul, Korea, Republic of | |
Contact: Chi-Kyung Kim, MD., PhD. ckkim7@korea.ac.kr | |
Kyung-Hee University Medical Center | Recruiting |
Seoul, Korea, Republic of | |
Contact: Sung-Hyuk Heo, MD., PhD. shheo73@khu.ac.kr | |
Samsung Medical Center, Sungkyunkwan University School of Medicine | Recruiting |
Seoul, Korea, Republic of | |
Contact: Oh-Young Bang, MD., PhD. ohyoung.bang@samsung.com | |
Seoul National University Hospital | Not yet recruiting |
Seoul, Korea, Republic of | |
Contact: Tae-Jung Kim, MD.,PhD. ttae35@gmail.com | |
Seoul St Mary's Hospital | Recruiting |
Seoul, Korea, Republic of | |
Contact: Ja-Seong Koo, MD., PhD. carotidstroke@gmail.com | |
Severance Hospital, Yonsei University Health System | Recruiting |
Seoul, Korea, Republic of | |
Contact: Hyo-Suk Nam, MD., PhD. hsnam@yuhs.ac |
Principal Investigator: | Keun-Sik Hong, MD., PhD. | Department of Neurology, Inje University Ilsan Paik Hospital |
Tracking Information | |||||
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First Submitted Date ICMJE | June 17, 2019 | ||||
First Posted Date ICMJE | June 20, 2019 | ||||
Last Update Posted Date | February 12, 2020 | ||||
Actual Study Start Date ICMJE | September 9, 2019 | ||||
Estimated Primary Completion Date | November 12, 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
The percentage of subjects with LDL-C decreased more than 50% at 90days (±14 days) compared to Baseline [ Time Frame: Baseline, Visit 4(Day 90) ] The percentage of subjects with LDL-C decreased more than 50% at 90days (±14 days) compared to Baseline
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Study on Rosuvastatin+Ezetimibe and Rosuvastatin for LDL-C Goal in Patients With Recent Ischemic Stroke | ||||
Official Title ICMJE | Moderate-intensity Rosuvastatin Plus Ezetimibe Versus High-intensity Rosuvastatin for Target LDL-C Goal Achievement in Patients With Recent Ischemic Stroke: a Randomized Clinical Trial | ||||
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 | ||||
Detailed Description |
The purpose of this study is to compare the efficiency and safety on the target LDL-C goal achievement between rosuvastatin 10 mg plus ezetimibe 10 mg (rosuvastatin/ezetimibe 10/10 mg) once daily versus rosuvastatin 20 mg once daily in patients with recent ischemic stroke. The target LDL-C goal achievement rate in patients with recent ischemic stroke has not been well studied. In particular, no clinical studies have been conducted comparing the efficacy and safety of low-dose rosuvastatin plus ezetimibe with high-dose rosuvastatin single agent for achieving target LDL-C levels. In this trial, the investigators aim to compare the efficacy of the target LDL-C achievement between rosuvastatin 10 mg plus ezetimibe 10 mg (rosuvastatin/ezetimibe 10/10 mg) and rosuvastatin 20 mg in patients with recent ischemic stroke. For this trial, more than 292 patients (584 total) per group will be enrolled. Subjects who were satisfied with the inclusion/exclusion criteria of this trial and who agreed to participate in the clinical trial in writing were randomly assigned to a 1:1 ratio in the experimental group (the low-dose combination of rosuvastatin plus ezetimibe) and comparator group (high-dose rosuvastatin). The duration of administration of the drug for clinical trials is 90 days (±14 days), and the efficacy and safety evaluation parameters are compared with baseline. |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 4 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Supportive Care |
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Condition ICMJE | Stroke, Ischemic | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
584 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | November 12, 2020 | ||||
Estimated Primary Completion Date | November 12, 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 19 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Korea, Republic of | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03993236 | ||||
Other Study ID Numbers ICMJE | ROSETTA-Stroke | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Keun-Sik Hong, Inje University | ||||
Study Sponsor ICMJE | Keun-Sik Hong | ||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Inje University | ||||
Verification Date | February 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |