High Dose and Low Dose of Atorvastatin in Patients With U... | NCT01306565

Studies
High Dose and Low Dose of Atorvastatin in Patients With Unstable Angina and NSTEMI (Non ST Elevation MI)

NCT01306565

Sponsor

Hormozgan University of Medical Sciences

Status

Completed

Last Update Posted

Mar 2, 2011Estimated

Enrollment

100Actual

Phase

Not Applicable

Conditions

Cardiovascular Disease

Interventions

Low dose Atorvastatin
High dose atorvastatin

Countries

Iran

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

Nov 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2009

Primary Completion Date

Jun 2010Actual

Completion Date

Jan 2011Actual

First Submitted Date

Mar 1, 2011

First Submission Date that Met QC Criteria

Mar 1, 2011

First Posted Date

Mar 2, 2011Estimated

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

Mar 1, 2011

Last Update Posted Date

Mar 2, 2011Estimated

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

The aim of this study is to compare the effect of high dose and low dose of Atorvastatin in reduction level of C-reactive protein (CRP) in patients with unstable angina and NSTEMI (Non ST Elevation MI) attending Shahid Mohammadi hospital in Bandar Abbas.

Detailed Description

This study compare the effect of 80mg atorvastatin followed by two 20mg daily atorvastatin with three 80mg daily atorvastatin in reduction of CRP in patients with unstable angina and NSTEMI (Non ST Elevation MI) attending Shahid Mohammadi hospital in Bandar Abbas in 2009.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
High dose atorvastatin	Active Comparator	Three 80mg daily doses of atorvastatin	Drug: Low dose Atorvastatin
Low dose Atorvastatin	Experimental	80mg atorvastatin followed by two 20mg daily atorvastatin	Drug: High dose atorvastatin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Low dose Atorvastatin	Drug	80mg atorvastatin followed by two 20mg daily atorvastatin	High dose atorvastatin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
CRP reduction	CRP reduction will be compared between two study groups	72 hours

Secondary Outcomes

Measure	Description	Time Frame
Drug side effects	Headache, Myopathy	72 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with unstable angina with chest discomfort at rest with normal EKG or St depression (at least 0.1mv) in two consecutive leads or new and deep T inversion (at least 0.2mv)

Exclusion Criteria:

Myocardial Infarction with ST elevation
Diabetes Mellitus
Previous statin use
Current infectious disease

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

Not provided

Overall Officials

Name	Affiliation	Role
Vahid Vahdatkhah	Hormozgan University of Medical Sciences	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hormozgan University of Medical Sciences		Bandar Abbas	Hormozgan	097145-3388	Iran

Condition Browse Module

MeSH Terms

ID	Term
D002318	Cardiovascular Diseases
D000789	Angina, Unstable

Ancestor Terms

ID	Term
D000787	Angina Pectoris
D017202	Myocardial Ischemia
D006331	Heart Diseases
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069059	Atorvastatin

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided