Atorvastatin Pre-Treatment Influences the Risk of Percuta... | NCT01058057

Studies
Atorvastatin Pre-Treatment Influences the Risk of Percutaneous Coronary Intervention (PCI) Study 2

NCT01058057

Sponsor

University Hospital, Motol

Status

Unknown status

Last Update Posted

Feb 3, 2010Estimated

Enrollment

200Estimated

Phase

Phase 3

Conditions

Coronary Artery Disease
Coronary Angioplasty

Interventions

atorvastatin

Countries

Czechia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2008

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2008

Primary Completion Date

Jun 2010Estimated

Completion Date

Not provided

First Submitted Date

Jan 27, 2010

First Submission Date that Met QC Criteria

Jan 27, 2010

First Posted Date

Jan 28, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 2, 2010

Last Update Posted Date

Feb 3, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

This randomized study investigates potential protective effect of high dose atorvastatin pre-treatment in patient with stable coronary artery disease undergoing percutaneous coronary intervention (PCI) and chronic statin therapy.

Two arms:

atorvastatin pre-treatment group (80mg atorvastatin for seven days)
control group (without atorvastatin pre-treatment, chronic statin treatment)

Primary endpoint:

Periprocedural myocardial infarction measured by troponin I level (time frame 24 hours)

Secondary endpoint:

Periprocedural myocardial infarction measured by creatine kinase myocardial band (time frame 24 hours)

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Atorvastatin	Experimental	Atorvastatin 80mg seven days pre-treatment before PCI	Drug: atorvastatin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
atorvastatin	Drug	atorvastatin 80mg p.o. daily seven days before PCI	Atorvastatin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
periprocedural myocardial infarction measured by troponin I level		24 hours after PCI

Secondary Outcomes

Measure	Description	Time Frame
periprocedural myocardial infarction measured by creatinine kinase myocardial band		24 hours after PCI

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Indication for percutaneous coronary intervention
Informed consent
Chronic statin therapy

Exclusion Criteria:

Acute coronary syndrome in last 14 days
Renal insufficiency (creatinine more 150 umol/l)
Diseases severely limiting prognosis
Previous participation in this study
Chronic occlusion of the coronary artery, bypass intervention, left main intervention
Chronic statin treatment with atorvastatin 80mg daily and rosuvastatin

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
David Zemanek, MD	Contact	+420608921		zejada@seznam.cz

Overall Officials

Name	Affiliation	Role
David Zemanek, MD	Department of Cardiology, University Hospital Motol	Principal Investigator
Josef Veselka, Prof., MD., PhD.	Department of Carldiology, University Hospital Motol	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dpt. of Cardiology, University Hospital Motol	Recruiting	Prague		15018	Czechia

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19699335	Background	Veselka J, Zemanek D, Hajek P, Maly M, Adlova R, Martinkovicova L, Tesar D. Effect of two-day atorvastatin pretreatment on the incidence of periprocedural myocardial infarction following elective percutaneous coronary intervention: a single-center, prospective, and randomized study. Am J Cardiol. 2009 Sep 1;104(5):630-3. doi: 10.1016/j.amjcard.2009.04.048. Epub 2009 Jun 24.
19643320

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

ID	Term
D011758	Pyrroles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds