Cardiovascular DiseaseNCT01306565
High Dose and Low Dose of Atorvastatin in Patients With Unstable Angina and NSTEMI (Non ST Elevation MI)
A study testing Low dose Atorvastatin and High dose atorvastatin in people with Cardiovascular Disease, run by Hormozgan University of Medical Sciences at 1 site in Iran.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- Low dose Atorvastatin and High dose atorvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIran
- Study dates
- Jan 2009to Jan 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Myocardial Infarction with ST elevation
- Diabetes Mellitus
- Previous statin use
- Current infectious disease
Trial locations and contacts
1 site in 1 country.
Iran1 site
Hormozgan University of Medical Sciences
Bandar Abbas, Hormozgan, 097145-3388
About this study
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)
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.
Read the 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.
- Conditions
- Cardiovascular Disease
- Being tested
- Low dose Atorvastatin, High dose atorvastatin
- Keywords
- Unstable angina, NSTMI, Statin, Atorvastatin
- Medical subject headings
- Cardiovascular Diseases, Angina, Unstable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low dose AtorvastatinDrug
Also called Lipitor
80mg atorvastatin followed by two 20mg daily atorvastatin
High dose atorvastatinDrug
Also called Lipitor
80mg daily atorvastatin for 72 hours
| Study group | Role | What they receive |
|---|---|---|
| High dose atorvastatin | Active comparator | Three 80mg daily doses of atorvastatin Receives: Drug: Low dose Atorvastatin |
| Low dose Atorvastatin | Experimental | 80mg atorvastatin followed by two 20mg daily atorvastatin Receives: Drug: High dose atorvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
CRP reduction
CRP reduction will be compared between two study groups
Measured: 72 hours
Secondary outcomes (1)
Drug side effects
Headache, Myopathy
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2011 (estimated)
- Study startJan 2009
- Primary completionJun 2010
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hormozgan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Vahid Vahdatkhah, Principal investigator, Hormozgan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01306565
- Sponsor's protocol ID
- Atorvastatin and CRP level
- Status last verified
- Nov 2008
- First submitted
- 1 Mar 2011
- Last updated
- 2 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01306565
- Acronym / sponsor ID
- Atorvastatin and CRP level
- Conditions
- Cardiovascular Disease
- Keywords
- Unstable angina, NSTMI, Statin, Atorvastatin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Hormozgan University of Medical SciencesUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 2 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High dose atorvastatin | Active comparator | Drug: Low dose AtorvastatinThree 80mg daily doses of atorvastatin |
| Low dose Atorvastatin | Experimental | Drug: High dose atorvastatin80mg atorvastatin followed by two 20mg daily atorvastatin |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (4 listed)
- Myocardial Infarction with ST elevation
- Diabetes Mellitus
- Previous statin use
- Current infectious disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low dose AtorvastatinAlso: Lipitor80mg atorvastatin followed by two 20mg daily atorvastatin | Drug | High dose atorvastatin |
| High dose atorvastatinAlso: Lipitor80mg daily atorvastatin for 72 hours | Drug | Low dose Atorvastatin |
Primary outcome
CRP reduction
Time frame: 72 hours
CRP reduction will be compared between two study groups
1 secondary outcome
Drug side effects
Time frame: 72 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vahid Vahdatkhah principal investigator
Hormozgan University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low dose Atorvastatin and High dose atorvastatin in people with Cardiovascular Disease, run by Hormozgan University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CRP reduction (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2011.