Viewing Study NCT01971606



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Last Modification Date: 2024-10-26 @ 11:14 AM
Study NCT ID: NCT01971606
Status: COMPLETED
Last Update Posted: 2013-11-01
First Post: 2013-10-23

Brief Title: Impact of High-dose Pretreatment of Rosuvastatin in Patients With Acute Coronary Syndrome Following Off-pump Coronary Artery Bypass Results From the HIROP-ACS HIgh-dose Pretreatment of Rosuvastatin During Off-Pump Coronary Bypass in Acute Coronary Syndrome Study
Sponsor: Yonsei University
Organization: Yonsei University

Study Overview

Official Title: None
Status: COMPLETED
Status Verified Date: 2013-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Periprocedural treatment with high-dose statins is known to have cardioprotective and pleiotropic effects such as anti-thrombotic and anti-inflammatory actions

-Objective to determine whether preoperative rosuvastatin loading is independently associated with reduced myocardial ischemia and clinical outcomes in patients with stable angina undergoing isolated off-pump coronary bypass OPCAB in patients with acute coronary syndrome

Study design

Prospective double-blinded single-center study of each 117 subjects enrolled
Subjects with acute coronary syndrome who meet all inclusion and exclusion criteria will be enrolled preoperatively
Eligible subjects will be randomized 11 to A High-dose rosuvastatin n117 vs B Placebo n117
The amount of preoperative administration of high-dose rosuvastatin will be 60mg of a total
All subjects will undergo OPCAB procedure - The primary and secondary endpoints will be compared at 30 days and 2 years postoperatively between two groups
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None