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NCT01936805 Clinical Trial

ROsuvastatin LOading and Clinical Outcomes Trial

Atherosclerosis Clinical Trial

— ROLOCO  

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01936805
Other study ID # 2173862
Secondary ID
Status Completed
Phase Phase 3
First received August 9, 2013
Last updated September 2, 2013
Start date January 2008
Est. completion date January 2012

Study information
Verified date September 2013
Source Yuksek Ihtisas Hospital
Contact n/a
Is FDA regulated No
Health authority Turkey: Ministry of Health
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 299
Est. completion date January 2012
Est. primary completion date January 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Rosuvastatin
A 40 mg loading dose of rosuvastatin was administrated 24 h before the PCI.

Locations
Country Name City State
Turkey Yuksek Ihtisas Hospital Ankara Altindag

Sponsors (1)
Lead Sponsor Collaborator
Yuksek Ihtisas Hospital

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary all cause death and composite of death or myocardial infarction from CV causes, TVR, or stroke 4 year No
Secondary all cause death 4 year No
Secondary composite of death or myocardial infarction from CV causes, TVR, or stroke 4 year No
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