Coronary Heart DiseasePhase 4NCT00917527
Endothelial Dysfunction in Subjects With History of Premature Coronary Artery Disease
A Phase 4 study testing Atorvastatin in people with Coronary Heart Disease, run by Yonsei University at 1 site in South Korea.
Trial summary
The aim of this prospective study is to investigate the prevalence of endothelial dysfunction in subjects with family history of premature coronary heart disease. At the same time, the effect of atorvastatin in treating subclinical endothelial dysfunction in those patients will be evaluated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Heart Disease
- What is being tested?
- Atorvastatin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 77 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2009to Jun 2013
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- within 1 year
- the siblings of premature coronary heart disease(male<55years old, female<65years old: Framingham Heart Study)patients admitted relevant hospital
Who cannot join
- Documented coronary heart disease
- Any woman of childbearing potential who is pregnant, seeking to become pregnant or suspects that she may be pregnant.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Severance Cardiovascular Hospital, Yonsei University College of Medicine
Seoul, 120-752
Hyuk-Jae Chang, MD, PhD
About this study
Official title: Randomized Placebo-controlled Crossover Trial of Endothelial Function Improvement in Subjects With History of Premature Coronary Artery Disease
The aim of this prospective study is to investigate the prevalence of endothelial dysfunction in subjects with family history of premature coronary heart disease. At the same time, the effect of atorvastatin in treating subclinical endothelial dysfunction in those patients will be evaluated.
- Conditions
- Coronary Heart Disease
- Being tested
- Atorvastatin
- Keywords
- Subjects with family history of coronary heart disease
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtorvastatinDrug
Atorvastatin 40mg/D for 6 weeks to improve endothelial dysfunction
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Not described Receives: Drug: Atorvastatin |
| Atorvastatin | Experimental | Not described Receives: Drug: Atorvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
improvement of endothelial dysfunction with endo-PAT2000
Measured: 6 weeks later drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionNov 2012 (estimated)
- Study completionJun 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 77 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyuk-Jae Chang, Yonsei University
- Investigators
- Hyuk-Jae Chang, MD, PhD, Principal investigator, Cardiology Division, Severance Cardiovascular Hospital, Yonsei University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00917527
- Sponsor's protocol ID
- 20090615
- Status last verified
- Jul 2012
- First submitted
- 9 Jun 2009
- Last updated
- 23 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Nasir K, Michos ED, Rumberger JA, Braunstein JB, Post WS, Budoff MJ, Blumenthal RS. Coronary artery calcification and family history of premature coronary heart disease: sibling history is more strongly associated than parental history. Circulation. 2004 Oct 12;110(15):2150-6. doi: 10.1161/01.CIR.0000144464.11080.14. Epub 2004 Oct 4.
PubMed 15466626Hong SJ, Chang HJ, Park S, Kang DR, Shin S, Cho IJ, Shim CY, Hong GR, Ha JW, Chung N. Impact of atorvastatin treatment in first-degree relatives of patients with premature coronary artery disease with endothelial dysfunction: a double-blind, randomized, placebo-controlled crossover trial. Clin Cardiol. 2013 Aug;36(8):480-5. doi: 10.1002/clc.22152. Epub 2013 Jun 10.
PubMed 23754711
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Placebo-controlled Crossover Trial of Endothelial Function Improvement in Subjects With History of Premature Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT00917527
- Acronym / sponsor ID
- 20090615
- Conditions
- Coronary Heart Disease
- Keywords
- Subjects with family history of coronary heart disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 77 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Nov 2012 (estimated)
- Study completion
- Jun 2013 (estimated)
- First posted
- 10 Jun 2009 (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 prospective study is to investigate the prevalence of endothelial dysfunction in subjects with family history of premature coronary heart disease. At the same time, the effect of atorvastatin in treating subclinical endothelial dysfunction in those patients will be evaluated.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Drug: Atorvastatin |
| Atorvastatin | Experimental | Drug: Atorvastatin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- within 1 year
- the siblings of premature coronary heart disease(male<55years old, female<65years old: Framingham Heart Study)patients admitted relevant hospital
Key exclusion criteria (2 listed)
- Documented coronary heart disease
- Any woman of childbearing potential who is pregnant, seeking to become pregnant or suspects that she may be pregnant.
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 40mg/D for 6 weeks to improve endothelial dysfunction | Drug | Atorvastatin, Control |
Primary outcome
improvement of endothelial dysfunction with endo-PAT2000
Time frame: 6 weeks later drug administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2012.
- Background: PubMed 15466626Nasir K, Michos ED, Rumberger JA, Braunstein JB, Post WS, Budoff MJ, Blumenthal RS. Coronary artery calcification and family history of premature coronary heart disease: sibling history is more strongly associated than parental history. Circulation. 2004 Oct 12;110(15):2150-6. doi: 10.1161/01.CIR.0000144464.11080.14. Epub 2004 Oct 4.
- Derived from this study: PubMed 23754711Hong SJ, Chang HJ, Park S, Kang DR, Shin S, Cho IJ, Shim CY, Hong GR, Ha JW, Chung N. Impact of atorvastatin treatment in first-degree relatives of patients with premature coronary artery disease with endothelial dysfunction: a double-blind, randomized, placebo-controlled crossover trial. Clin Cardiol. 2013 Aug;36(8):480-5. doi: 10.1002/clc.22152. Epub 2013 Jun 10.
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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.
Hyuk-Jae Chang, MD, PhD principal investigator
Cardiology Division, Severance Cardiovascular Hospital, Yonsei University College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Atorvastatin in people with Coronary Heart Disease, run by Yonsei University at 1 site in South Korea.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 23 Jul 2012. 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 South Korea. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hyuk-Jae Chang, MD, PhD (82-2-2228-8461, hjchang@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
improvement of endothelial dysfunction with endo-PAT2000 (time frame: 6 weeks later drug administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00917527, which also lists 2 linked publications.
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 23 Jul 2012.