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

Cardiovascular Disease Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01306565
• Other study ID #: Atorvastatin and CRP level
• Status: Completed
• Phase: N/A
• First received: March 1, 2011
• Last updated: March 1, 2011
• Start date: January 2009
• Est. completion date: January 2011

Study information

• Verified date: November 2008
• Source: Hormozgan University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 2011
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Angina, Unstable
• Cardiovascular Disease
• Cardiovascular Diseases

Intervention

Drug:
• Low dose Atorvastatin
80mg atorvastatin followed by two 20mg daily atorvastatin
• High dose atorvastatin
80mg daily atorvastatin for 72 hours

Locations

Country	Name	City	State
Iran, Islamic Republic of	Hormozgan University of Medical Sciences	Bandar Abbas	Hormozgan

Sponsors (1)

Lead Sponsor	Collaborator
Hormozgan University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CRP reduction	CRP reduction will be compared between two study groups	72 hours	No
Secondary	Drug side effects	Headache, Myopathy	72 hours	Yes