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Completed

NCT Number: NCT00469326

Atorvastatin Pre-Treatment Influences the Risk of Percutaneous Coronary Intervention Study

This study investigates potential protective effect of atorvastatin pre-treatment in patient with stable coronary artery disease undergoing percutaneous coronary intervention (PCI). Patient are randomized to two groups: atorvastatin pre-treatment group (80mg atorvastatin two days before PCI) and control group (PCI without atorvastatin pretreatment). Endpoint is myocardial infarction measured by troponin I and creatine kinase myocardial band.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Department of Cardiology, CardioVascular Center, University Hospital Motol

Prague, 150 18, Czechia

About this study

Randomized studies have shown that pre-treatment with atorvastatin may reduced periprocedural myocardial in patient with stable angina during elective PCI. These data provide evidence-based support for using atorvastatin 7 days before PCI (dosage 40mg/d), alternatively three or more days (unknown dosage). We want to confirm this results for shorter pre-treatment period (two days) with dosage 80mg per day.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • stable angina in last month
  • indication for percutaneous coronary intervention
  • informed consent

Exclusion criteria

  • acute coronary syndrome in last 14 days
  • renal insufficiency (creatinine more 150 µmol/l)
  • diseases severely limiting prognosis
  • immunosuppressive treatment
  • statin one month before randomization
  • occlusion of the coronary artery
  • previous participation in this study

Treatment and study plan

atorvastatin

Drug

two days 80mg atorvastatin pre-treatment before PCI

Other names: Torvacard

Primary outcomes

  1. periprocedural myocardial infarction measured by troponin I level

    Time frame: 24 hours

Secondary outcomes

  1. periprocedural myocardial infarction measured by creatine kinase myocardial band

    Time frame: 24 hours

Sponsors and collaborators

Lead sponsor

University Hospital, Motol

Other

Registry information

Acronym: TIPS

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
May 4, 2007
Registry last updated
Jan 27, 2009

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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