Angina Pectoris, VariantPhase 4ESAVANCT00620204
Efficacy Study of Atorvastatin to Treat Variant Angina
A Phase 4 study testing atorvastatin in people with Angina Pectoris, Variant, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The objective of this study is to evaluate effect of statin treatment for vasospastic angina. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Angina Pectoris, Variant
- What is being tested?
- atorvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2008to Dec 2010
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Vasospastic angina or spontaneous spasm during coronary angiography (Vasospastic angina is defined as Thrombolysis In Myocardial Infarction (TIMI) flow grade 0-2 noted in intracoronary ergonovine provocation test and development of chest pain or EKG change; Spontaneous spasm is defined as TIMI flow grade 0-2 of coronary artery without ergonovine injection)
- Normal or insignificant lesion (diameter stenosis <50%) on coronary angiography
Who cannot join
- Elevated liver enzyme: serum aspartate aminotransferase or alanine aminotransferase concentrations more than 3 times the upper limit of normal
- Significant lesion( diameter stenosis ≥50%) documented in coronary angiography
- Pregnancy
- Prior percutaneous coronary intervention or coronary artery bypass surgery
- Previous statin use
- Impaired renal function with serum creatinine ≥ 2.0 mg/dl
- Severe left ventricular dysfunction ( LVEF ≤ 30% on echocardiography)
- Myopathy
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this study is to evaluate effect of statin treatment for vasospastic angina.
Read the detailed description
Vasospastic angina is presented by myocardial ischemia with spasm of coronary artery accompanying chest pain or discomfort. The precise mechanisms have not been established, but a reduction in NO (nitric oxide) production, an imbalance between endothelium-derived relaxing and contracting factors,or an injury of endothelium have been suggested.
Impaired FMD(flow mediated endothelium-dependent vasodilation) in the brachial artery was demonstrated in vasospastic angina,and improvement of endothelial dysfunction with treatment of statin is documented in several studies.
So, we expect that statin treatment for vasospastic angina provide additional therapeutic effects via improvement of endothelial dysfunction.
- Conditions
- Angina Pectoris, Variant
- Being tested
- atorvastatin
- Keywords
- atorvastatin, Angina Pectoris, Variant, endothelial dysfunction
- Medical subject headings
- Angina Pectoris, Variant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
atorvastatinDrug
Also called Lipitor®
atorvastatin 40mg qd for 1 year
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Atorvastatin group Receives: Drug: atorvastatin |
| B | No intervention | Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ergonovine provocation test 24hrs later after admission
Measured: 1 year later
Secondary outcomes (1)
Chest pain with EKG change during admission for 24hrs at 12mo. later (All medications are withheld for 48hrs. before admission)
Measured: 1year later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2008 (estimated)
- Study startJan 2008
- Primary completionDec 2009 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Angina Pectoris, VariantStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Hyun-chul Gwon, MD,PhD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00620204
- Sponsor's protocol ID
- 2008-01-018
- Acronym
- ESAVA
- Status last verified
- Apr 2009
- First submitted
- 10 Feb 2008
- Last updated
- 6 Apr 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Study of Atorvastatin to Treat Variant Angina
- ClinicalTrials.gov ID
- NCT00620204
- Acronym / sponsor ID
- ESAVA / 2008-01-018
- Conditions
- Angina Pectoris, Variant
- Keywords
- atorvastatin, Angina Pectoris, Variant, endothelial dysfunction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Dec 2009 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 21 Feb 2008 (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 objective of this study is to evaluate effect of statin treatment for vasospastic angina.
Detailed description
Vasospastic angina is presented by myocardial ischemia with spasm of coronary artery accompanying chest pain or discomfort. The precise mechanisms have not been established, but a reduction in NO (nitric oxide) production, an imbalance between endothelium-derived relaxing and contracting factors,or an injury of endothelium have been suggested.
Impaired FMD(flow mediated endothelium-dependent vasodilation) in the brachial artery was demonstrated in vasospastic angina,and improvement of endothelial dysfunction with treatment of statin is documented in several studies.
So, we expect that statin treatment for vasospastic angina provide additional therapeutic effects via improvement of endothelial dysfunction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: atorvastatinAtorvastatin group |
| B | No intervention | –Control group |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Vasospastic angina or spontaneous spasm during coronary angiography (Vasospastic angina is defined as Thrombolysis In Myocardial Infarction (TIMI) flow grade 0-2 noted in intracoronary ergonovine provocation test and development of chest pain or EKG change; Spontaneous spasm is defined as TIMI flow grade 0-2 of coronary artery without ergonovine injection)
- Normal or insignificant lesion (diameter stenosis <50%) on coronary angiography
Key exclusion criteria (8 listed)
- Elevated liver enzyme: serum aspartate aminotransferase or alanine aminotransferase concentrations more than 3 times the upper limit of normal
- Significant lesion( diameter stenosis ≥50%) documented in coronary angiography
- Pregnancy
- Prior percutaneous coronary intervention or coronary artery bypass surgery
- Previous statin use
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 |
|---|---|---|
| atorvastatinAlso: Lipitor®atorvastatin 40mg qd for 1 year | Drug | A |
Primary outcome
Ergonovine provocation test 24hrs later after admission
Time frame: 1 year later
1 secondary outcome
Chest pain with EKG change during admission for 24hrs at 12mo. later (All medications are withheld for 48hrs. before admission)
Time frame: 1year later
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2009.
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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.
Hyun-chul Gwon, MD,PhD principal investigator
Samsung Medical Center
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 Angina Pectoris, Variant, run by Samsung Medical Center 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 8 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 6 Apr 2009. 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. 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 Hyun-chul Gwon, MD,PhD (82-2-3410-3418, hcgwon@smc.samsung.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ergonovine provocation test 24hrs later after admission (time frame: 1 year later). 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 6 Apr 2009.