Back to resultsROsuvastatin LOading and Clinical Outcomes Trial (ROLOCO)
Primary Purpose
Atherosclerosis
Status
Completed
Phase
Phase 3
Locations
Turkey
Study Type
Interventional
Intervention
Rosuvastatin
Sponsored by
About this trial
This is an interventional treatment trial for Atherosclerosis
Eligibility Criteria
Inclusion Criteria:
- statin-naive patients
- stable ischemic heart disease
- de novo lesions appropriate for PCI
Exclusion Criteria:
- current statin use
- statin allergic patients
- acute coronary syndromes
- lesions not appropriate for PCI
- refusal for participation
- statin quitting during follow- up
Sites / Locations
- Yuksek Ihtisas Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Rosuvastatin
Control
Arm Description
A 40 mg loading dose of rosuvastatin was administrated 24 h before the PCI.
A loading dose of placebo was administrated 24 h before the PCI.
Outcomes
Primary Outcome Measures
all cause death and composite of death or myocardial infarction from CV causes, TVR, or stroke
Secondary Outcome Measures
all cause death
composite of death or myocardial infarction from CV causes, TVR, or stroke
Full Information
NCT ID
NCT01936805
First Posted
August 9, 2013
Last Updated
September 2, 2013
Sponsor
Yuksek Ihtisas Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01936805
Brief Title
ROsuvastatin LOading and Clinical Outcomes Trial
Acronym
ROLOCO
Study Type
Interventional
2. Study Status
Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yuksek Ihtisas Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of the present study was to evaluate the effect of pre-procedural single high loading dose (40 mg) of rosuvastatin on the primary end-points of all cause mortality and composite of death or myocardial infarction from cardiovascular (CV) causes, target vessel revascularization (TVR), or stroke.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atherosclerosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
299 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rosuvastatin
Arm Type
Active Comparator
Arm Description
A 40 mg loading dose of rosuvastatin was administrated 24 h before the PCI.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
A loading dose of placebo was administrated 24 h before the PCI.
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin
Intervention Description
A 40 mg loading dose of rosuvastatin was administrated 24 h before the PCI.
Primary Outcome Measure Information:
Title
all cause death and composite of death or myocardial infarction from CV causes, TVR, or stroke
Time Frame
4 year
Secondary Outcome Measure Information:
Title
all cause death
Time Frame
4 year
Title
composite of death or myocardial infarction from CV causes, TVR, or stroke
Time Frame
4 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
statin-naive patients
stable ischemic heart disease
de novo lesions appropriate for PCI
Exclusion Criteria:
current statin use
statin allergic patients
acute coronary syndromes
lesions not appropriate for PCI
refusal for participation
statin quitting during follow- up
Facility Information:
Facility Name
Yuksek Ihtisas Hospital
City
Ankara
State/Province
Altindag
ZIP/Postal Code
06100
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
ROsuvastatin LOading and Clinical Outcomes Trial
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