ROsuvastatin LOading and Clinical Outcomes Trial (ROLOCO)

Yuksek Ihtisas Hospital

Status and phase: Completed; Phase 3

Conditions: Atherosclerosis

Treatments: Drug: Rosuvastatin

Study type: Interventional

Funder types: Other

Identifiers

NCT01936805

2173862

Details and patient eligibility

About

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.

Enrollment: 299 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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299 participants in 2 patient groups, including a placebo group

Rosuvastatin

Active Comparator group

Description:

A 40 mg loading dose of rosuvastatin was administrated 24 h before the PCI.

Treatment:

Drug: Rosuvastatin

Control

Placebo Comparator group

Description:

A loading dose of placebo was administrated 24 h before the PCI.