Vascular CalcificationPhase 3NCT00481364
Atorvastatin Treatment to Attenuate the Progression of Cardiovascular Disease in Hemodialysis Patients
A Phase 3 study testing atorvastatin in people with Vascular Calcification and Atherosclerosis, run by Ercan OK at 1 site in Turkey (Türkiye).
Trial summary
This prospective, randomized, controlled study aims to investigate the effects of atorvastatin treatment in hemodialysis patients concerning progression of coronary artery calcification, progression of carotid artery intima-media thickness, endothelial function, and inflammation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Vascular Calcification, Atherosclerosis, Dyslipidemia
- What is being tested?
- atorvastatin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 446 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Nov 2006to Dec 2008
- Phase
- Phase 3
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged between 18 and 80 years
- on maintenance bicarbonate hemodialysis scheduled thrice weekly, at least 12 hours/week
- willingness to participate to the study with a written informed consent
Who cannot join
- to have serious life-limiting co-morbid situations, namely active malignancy, active infection, end-stage cardiac, pulmonary, or hepatic disease
- to be scheduled for living donor renal transplantation
- pregnancy or lactating
- history of coronary bypass grafting, acute myocardial infarction or unstable angina pectoris confirmed by angiography within three months of randomization
- presence of an absolute indication to use lipid lowering drug or an absolute contraindication for lipid lowering therapy according to investigator's opinion
- history of statin sensitivity or adverse reaction to statins
Show all 15Show fewer
- receiving any lipid-lowering agents within three months of randomization
- uncontrolled hypothyroidism defined as TSH level higher than 1.5 times of upper limit
- receipt of any investigational drug within 30 days before randomization
- inability to tolerate oral medication or history of significant malabsorption
- treatment with steroids or immunosuppressive drugs
- alcohol abuse, drug abuse
- ALT and/or AST levels more than three times above the upper limit of normal or symptomatic hepatobiliary disease
- unexplained CK > 3 times the upper limit of the normal range
- inability to give informed consent because of mental incompetence or a psychiatric disorder
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ege University School of Medicine, Division of Nephrology
Bornova, İzmir, 35100
About this study
Official title: Atorvastatin Treatment to Attenuate the Progression of Cardiovascular Disease: Prospective, Randomized, Controlled Study
This prospective, randomized, controlled study aims to investigate the effects of atorvastatin treatment in hemodialysis patients concerning progression of coronary artery calcification, progression of carotid artery intima-media thickness, endothelial function, and inflammation.
Read the detailed description
The effects of statin treatment on coronary artery calcifications, carotid artery intima-media thickness, and endothelial functions have never been investigated in hemodialysis patients. Regarding inflammation, the present data in hemodialysis patients are derived from small studies with short follow-up.
We postulate that atorvastatin would reduce progression of coronary calcification and carotid artery intima-media thickness, decrease inflammation, and improve endothelial function.
In this prospective, controlled, randomized study, four hundred forty-six prevalent hemodialysis patients who meet inclusion and exclusion criteria will be randomized to atorvastatin (20 mg/day in first month; increased to 40 mg/day afterwards) and placebo arms (each arm consists of 223 patients), after completion of baseline investigations. Randomization will be performed with random permuted blocks and will be stratified according to dialysis center, age, sex, diabetic status, duration of dialysis, high flux dialyser use, and dialysate calcium level. Follow-up period will be twelve months.
It is estimated that 446 patients would provide 90% power with a two-sided, alpha error rate of 5%, of detecting a significant difference between treatment arms. Dropout rate is expected to be 20%, not to be replaced.
- Conditions
- Vascular Calcification, Atherosclerosis, Dyslipidemia, Inflammation
- Being tested
- atorvastatin, placebo
- Keywords
- hemodialysis, endothelial function, coronary artery calcification, atherosclerosis, statin
- Medical subject headings
- Vascular Calcification, Atherosclerosis, Dyslipidemias, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
atorvastatinDrug
atorvastatin 40 mg/day
placeboDrug
1 tb/day
| Study group | Role | What they receive |
|---|---|---|
| Statin | Active comparator | Atorvastatin 40 mg/day Receives: Drug: atorvastatin |
| Placebo | Placebo comparator | placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression of coronary artery calcification score
Measured: one year
progression of carotid artery intima-media thickness
Measured: one year
changes in the level of hsCRP
Measured: one year
Secondary outcomes (2)
changes in the endothelial function
Measured: one year
changes in the level of hsCRP
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2007 (estimated)
- Study startNov 2006
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular CalcificationStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 446 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ercan OK
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor-investigator, Ercan OK, Ege University
- Investigators
- Ercan Ok, MD, Principal investigator, Ege University, Division of Nephrology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00481364
- Sponsor's protocol ID
- 06-4.1/2
- Status last verified
- Sep 2013
- First submitted
- 30 May 2007
- Last updated
- 9 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atorvastatin Treatment to Attenuate the Progression of Cardiovascular Disease: Prospective, Randomized, Controlled Study
- ClinicalTrials.gov ID
- NCT00481364
- Acronym / sponsor ID
- 06-4.1/2
- Conditions
- Vascular Calcification, Atherosclerosis, Dyslipidemia, Inflammation
- Keywords
- hemodialysis, endothelial function, coronary artery calcification, atherosclerosis, statin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 446 participants (actual)
- Lead sponsor
- Ercan OKUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Nov 2006
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 1 Jun 2007 (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.
This prospective, randomized, controlled study aims to investigate the effects of atorvastatin treatment in hemodialysis patients concerning progression of coronary artery calcification, progression of carotid artery intima-media thickness, endothelial function, and inflammation.
Detailed description
The effects of statin treatment on coronary artery calcifications, carotid artery intima-media thickness, and endothelial functions have never been investigated in hemodialysis patients. Regarding inflammation, the present data in hemodialysis patients are derived from small studies with short follow-up.
We postulate that atorvastatin would reduce progression of coronary calcification and carotid artery intima-media thickness, decrease inflammation, and improve endothelial function.
In this prospective, controlled, randomized study, four hundred forty-six prevalent hemodialysis patients who meet inclusion and exclusion criteria will be randomized to atorvastatin (20 mg/day in first month; increased to 40 mg/day afterwards) and placebo arms (each arm consists of 223 patients), after completion of baseline investigations. Randomization will be performed with random permuted blocks and will be stratified according to dialysis center, age, sex, diabetic status, duration of dialysis, high flux dialyser use, and dialysate calcium level. Follow-up period will be twelve months.
It is estimated that 446 patients would provide 90% power with a two-sided, alpha error rate of 5%, of detecting a significant difference between treatment arms. Dropout rate is expected to be 20%, not to be replaced.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Statin | Active comparator | Drug: atorvastatinAtorvastatin 40 mg/day |
| Placebo | Placebo comparator | Drug: placeboplacebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- aged between 18 and 80 years
- on maintenance bicarbonate hemodialysis scheduled thrice weekly, at least 12 hours/week
- willingness to participate to the study with a written informed consent
Key exclusion criteria (15 listed)
- to have serious life-limiting co-morbid situations, namely active malignancy, active infection, end-stage cardiac, pulmonary, or hepatic disease
- to be scheduled for living donor renal transplantation
- pregnancy or lactating
- history of coronary bypass grafting, acute myocardial infarction or unstable angina pectoris confirmed by angiography within three months of randomization
- presence of an absolute indication to use lipid lowering drug or an absolute contraindication for lipid lowering therapy according to investigator's opinion
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 |
|---|---|---|
| atorvastatinatorvastatin 40 mg/day | Drug | Statin |
| placebo1 tb/day | Drug | Placebo |
Primary outcome
progression of coronary artery calcification score
Time frame: one year
progression of carotid artery intima-media thickness
Time frame: one year
changes in the level of hsCRP
Time frame: one year
2 secondary outcomes
changes in the endothelial function
Time frame: one year
changes in the level of hsCRP
Time frame: one year
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 9 Sep 2013.
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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.
Ercan Ok, MD principal investigator
Ege University, Division of Nephrology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing atorvastatin in people with Vascular Calcification and Atherosclerosis, run by Ercan OK at 1 site in Turkey (Türkiye).
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 3 inclusion and 15 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 9 Sep 2013. 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 Turkey (Türkiye). 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
progression of coronary artery calcification score (time frame: one year). The study lists 3 primary outcomes in all. 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 9 Sep 2013.