ROsuvastatin LOading and Clinical Outcomes Trial

Phase 3

Completed

• Conditions: Atherosclerosis
• Interventions: Drug: Rosuvastatin

• Registration Number: NCT01936805
• Lead Sponsor: Yuksek Ihtisas Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Study First Submitted: 2013-08-09
• Status Verified: 2013-09
• Study First Submitted QC: 2013-09-02
• Last Update Submitted: 2013-09-02
• Study First Posted: 2013-09-06
• Last Update Posted: 2013-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 299

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rosuvastatin	Rosuvastatin	A 40 mg loading dose of rosuvastatin was administrated 24 h before the PCI.

Primary Outcome Measures

Name	Time	Method
all cause death and composite of death or myocardial infarction from CV causes, TVR, or stroke	4 year

Secondary Outcome Measures

Name	Time	Method
all cause death	4 year
composite of death or myocardial infarction from CV causes, TVR, or stroke	4 year

Trial Locations

Locations (1)

Yuksek Ihtisas Hospital; 🇹🇷 Ankara, Altindag, Turkey