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

Sponsored by:	University Hospital, Motol
Information provided by:	University Hospital, Motol
ClinicalTrials.gov Identifier:	NCT00469326

Purpose

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.

Condition	Intervention	Phase
Coronary Artery Disease	Drug: Atorvastatin	Phase III

MedlinePlus related topics: Coronary Artery Disease Heart Attack

Drug Information available for: Atorvastatin Atorvastatin calcium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Atorvastatin Pre-Treatment Influences the Risk of Percutaneous Coronary Intervention Study

Further study details as provided by University Hospital, Motol:

Primary Outcome Measures:

periprocedural myocardial infarction measured by troponin I level [ Time Frame: 24 hours ]

Secondary Outcome Measures:

periprocedural myocardial infarction measured by creatine kinase myocardial band [ Time Frame: 24 hours ]

Enrollment:	200
Study Start Date:	April 2005
Study Completion Date:	December 2008
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
atorvastatin: Active Comparator atorvastatin pre-treatment group (80mg atorvastatin two days before PCI)	Drug: Atorvastatin two days 80mg atorvastatin pre-treatment before PCI
control: No Intervention PCI without atorvastatin pretreatment	Drug: Atorvastatin two days 80mg atorvastatin pre-treatment before PCI

Detailed Description:

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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00469326

Locations

Czech Republic
Department of Cardiology, CardioVascular Center, University Hospital Motol
Prague, Czech Republic, 150 18

Sponsors and Collaborators

University Hospital, Motol

Investigators

Study Chair:

Josef Veselka, Prof., PhD.

Department of Cardiology, Cardiovascular Center, University Hospital Motol, Prague, Czech Republic

More Information

Publications:

Pasceri V, Patti G, Nusca A, Pristipino C, Richichi G, Di Sciascio G; ARMYDA Investigators. Randomized trial of atorvastatin for reduction of myocardial damage during coronary intervention: results from the ARMYDA (Atorvastatin for Reduction of MYocardial Damage during Angioplasty) study. Circulation. 2004 Aug 10;110(6):674-8. Epub 2004 Jul 26.

Briguori C, Colombo A, Airoldi F, Violante A, Focaccio A, Balestrieri P, Paolo Elia P, Golia B, Lepore S, Riviezzo G, Scarpato P, Librera M, Bonizzoni E, Ricciardelli B. Statin administration before percutaneous coronary intervention: impact on periprocedural myocardial infarction. Eur Heart J. 2004 Oct;25(20):1822-8.

Responsible Party:	University Hospital Motol ( University Hospital Motol )
Study ID Numbers:	KC EK-361/05
Study First Received:	May 3, 2007
Last Updated:	January 26, 2009
ClinicalTrials.gov Identifier:	NCT00469326 History of Changes
Health Authority:	Czech Republic: State Institute for Drug Control

Keywords provided by University Hospital, Motol:

coronary artery disease
percutaneous coronary intervention
atorvastatin

Study placed in the following topic categories:

Arterial Occlusive Diseases
Antimetabolites
Heart Diseases
Myocardial Ischemia
Antilipemic Agents
Vascular Diseases
Ischemia

Arteriosclerosis
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Coronary Disease
Coronary Artery Disease
Atorvastatin

Additional relevant MeSH terms:

Arterial Occlusive Diseases
Antimetabolites
Heart Diseases
Molecular Mechanisms of Pharmacological Action
Myocardial Ischemia
Antilipemic Agents
Vascular Diseases
Enzyme Inhibitors
Arteriosclerosis

Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions
Coronary Disease
Therapeutic Uses
Cardiovascular Diseases
Coronary Artery Disease
Atorvastatin

ClinicalTrials.gov processed this record on May 06, 2009