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ROsuvastatin LOading and Clinical Outcomes Trial (ROLOCO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01936805
Recruitment Status : Completed
First Posted : September 6, 2013
Last Update Posted : September 6, 2013
Sponsor:
Information provided by (Responsible Party):
Serkan Cay, Yuksek Ihtisas Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Atherosclerosis Drug: Rosuvastatin Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 299 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : January 2008
Actual Primary Completion Date : January 2012
Actual Study Completion Date : January 2012

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Rosuvastatin
A 40 mg loading dose of rosuvastatin was administrated 24 h before the PCI.
 Drug: Rosuvastatin
A 40 mg loading dose of rosuvastatin was administrated 24 h before the PCI.
Placebo Comparator: Control
A loading dose of placebo was administrated 24 h before the PCI.


Outcome Measures
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Primary Outcome Measures :
  1. all cause death and composite of death or myocardial infarction from CV causes, TVR, or stroke [ Time Frame: 4 year ]

Secondary Outcome Measures :
  1. all cause death [ Time Frame: 4 year ]
  2. composite of death or myocardial infarction from CV causes, TVR, or stroke [ Time Frame: 4 year ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01936805


Locations
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Turkey
Yuksek Ihtisas Hospital
Ankara, Altindag, Turkey, 06100
Sponsors and Collaborators
Yuksek Ihtisas Hospital
More Information
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Responsible Party: Serkan Cay, Associate Professor, Yuksek Ihtisas Hospital
ClinicalTrials.gov Identifier: NCT01936805    
Other Study ID Numbers: 2173862
First Posted: September 6, 2013    Key Record Dates
Last Update Posted: September 6, 2013
Last Verified: September 2013
Additional relevant MeSH terms:
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Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Rosuvastatin Calcium
Anticholesteremic Agents
 Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors