- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01306565
High Dose and Low Dose of Atorvastatin in Patients With Unstable Angina and NSTEMI (Non ST Elevation MI)
March 1, 2011 updated by: Hormozgan University of Medical Sciences
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)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Hormozgan
-
Bandar Abbas, Hormozgan, Iran, Islamic Republic of, 097145-3388
- Hormozgan University of Medical Sciences
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: High dose atorvastatin
Three 80mg daily doses of atorvastatin
|
80mg atorvastatin followed by two 20mg daily atorvastatin
Other Names:
|
EXPERIMENTAL: Low dose Atorvastatin
80mg atorvastatin followed by two 20mg daily atorvastatin
|
80mg daily atorvastatin for 72 hours
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
CRP reduction
Time Frame: 72 hours
|
CRP reduction will be compared between two study groups
|
72 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Drug side effects
Time Frame: 72 hours
|
Headache, Myopathy
|
72 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Vahid Vahdatkhah, Hormozgan University of Medical Sciences
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2009
Primary Completion (ACTUAL)
June 1, 2010
Study Completion (ACTUAL)
January 1, 2011
Study Registration Dates
First Submitted
March 1, 2011
First Submitted That Met QC Criteria
March 1, 2011
First Posted (ESTIMATE)
March 2, 2011
Study Record Updates
Last Update Posted (ESTIMATE)
March 2, 2011
Last Update Submitted That Met QC Criteria
March 1, 2011
Last Verified
November 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Myocardial Ischemia
- Heart Diseases
- Vascular Diseases
- Pain
- Neurologic Manifestations
- Chest Pain
- Angina Pectoris
- Cardiovascular Diseases
- Angina, Unstable
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Atorvastatin
Other Study ID Numbers
- Atorvastatin and CRP level
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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