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

This study has been completed.
Sponsor:
Information provided by:
Hormozgan University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01306565
First received: March 1, 2011
Last updated: NA
Last verified: November 2008
History: No changes posted
  Purpose

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.


Condition Intervention
Cardiovascular Disease
Drug: Low dose Atorvastatin
Drug: High dose atorvastatin

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

Resource links provided by NLM:


Further study details as provided by Hormozgan University of Medical Sciences:

Primary Outcome Measures:
  • CRP reduction [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
    CRP reduction will be compared between two study groups


Secondary Outcome Measures:
  • Drug side effects [ Time Frame: 72 hours ] [ Designated as safety issue: Yes ]
    Headache, Myopathy


Enrollment: 100
Study Start Date: January 2009
Study Completion Date: January 2011
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: High dose atorvastatin
Three 80mg daily doses of atorvastatin
Drug: Low dose Atorvastatin
80mg atorvastatin followed by two 20mg daily atorvastatin
Other Name: Lipitor
Experimental: Low dose Atorvastatin
80mg atorvastatin followed by two 20mg daily atorvastatin
Drug: High dose atorvastatin
80mg daily atorvastatin for 72 hours
Other Name: Lipitor

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01306565

Locations
Iran, Islamic Republic of
Hormozgan University of Medical Sciences
Bandar Abbas, Hormozgan, Iran, Islamic Republic of, 097145-3388
Sponsors and Collaborators
Hormozgan University of Medical Sciences
Investigators
Principal Investigator: Vahid Vahdatkhah Hormozgan University of Medical Sciences
  More Information

No publications provided

Responsible Party: Vahid Vahdatkhah, Hormozgan University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01306565     History of Changes
Other Study ID Numbers: Atorvastatin and CRP level
Study First Received: March 1, 2011
Last Updated: March 1, 2011
Health Authority: Iran: Ministry of Health

Keywords provided by Hormozgan University of Medical Sciences:
Unstable angina
NSTMI
Statin
Atorvastatin

Additional relevant MeSH terms:
Angina, Unstable
Cardiovascular Diseases
Angina Pectoris
Myocardial Ischemia
Heart Diseases
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Atorvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 21, 2014