search
Back to results

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

Primary Purpose

Cardiovascular Disease

Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Low dose Atorvastatin
High dose atorvastatin
Sponsored by
Hormozgan University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiovascular Disease focused on measuring Unstable angina, NSTMI, Statin, Atorvastatin

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hormozgan University of Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

High dose atorvastatin

Low dose Atorvastatin

Arm Description

Three 80mg daily doses of atorvastatin

80mg atorvastatin followed by two 20mg daily atorvastatin

Outcomes

Primary Outcome Measures

CRP reduction
CRP reduction will be compared between two study groups

Secondary Outcome Measures

Drug side effects
Headache, Myopathy

Full Information

First Posted
March 1, 2011
Last Updated
March 1, 2011
Sponsor
Hormozgan University of Medical Sciences
search

1. Study Identification

Unique Protocol Identification Number
NCT01306565
Brief Title
High Dose and Low Dose of Atorvastatin in Patients With Unstable Angina and NSTEMI (Non ST Elevation MI)
Official Title
Comparison Between Effect of High Dose and Low Dose of Atorvastatin in Reduction Level of CRP in Patients With Unstable Angina and NSTEMI (Non ST Elevation MI)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2008
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hormozgan University of Medical Sciences

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Disease
Keywords
Unstable angina, NSTMI, Statin, Atorvastatin

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High dose atorvastatin
Arm Type
Active Comparator
Arm Description
Three 80mg daily doses of atorvastatin
Arm Title
Low dose Atorvastatin
Arm Type
Experimental
Arm Description
80mg atorvastatin followed by two 20mg daily atorvastatin
Intervention Type
Drug
Intervention Name(s)
Low dose Atorvastatin
Other Intervention Name(s)
Lipitor
Intervention Description
80mg atorvastatin followed by two 20mg daily atorvastatin
Intervention Type
Drug
Intervention Name(s)
High dose atorvastatin
Other Intervention Name(s)
Lipitor
Intervention Description
80mg daily atorvastatin for 72 hours
Primary Outcome Measure Information:
Title
CRP reduction
Description
CRP reduction will be compared between two study groups
Time Frame
72 hours
Secondary Outcome Measure Information:
Title
Drug side effects
Description
Headache, Myopathy
Time Frame
72 hours

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vahid Vahdatkhah
Organizational Affiliation
Hormozgan University of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hormozgan University of Medical Sciences
City
Bandar Abbas
State/Province
Hormozgan
ZIP/Postal Code
097145-3388
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs