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Completed

NCT Number: NCT01936805

ROsuvastatin LOading and Clinical Outcomes Trial

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.

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Key information

Conditions

Atherosclerosis Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Yuksek Ihtisas Hospital

Ankara, Altindag, 06100, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rosuvastatin

Drug

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

Primary outcomes

  1. all cause death and composite of death or myocardial infarction from CV causes, TVR, or stroke

    Time frame: 4 year

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Yuksek Ihtisas Hospital

Other

Registry information

Acronym: ROLOCO

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Sep 6, 2013
Registry last updated
Sep 6, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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