Angina Pectoris, VariantPhase 4STAVANCT02790528
Statin Therapy In Patients With Vasospastic Angina
A Phase 4 study testing Atorvastatin in people with Angina Pectoris, Variant and Statins, HMG-CoA, run by Seung-Jung Park at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate whether statin is effective in the treatment of vasospastic angina. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Angina Pectoris, Variant, Statins, HMG-CoA
- What is being tested?
- Atorvastatin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2017to Dec 2023
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 19 and more
- Vasospastic angina
- LDL less than 160mg/dl
- Written consent
Who cannot join
- Coronary artery stenosis more than 50% or ischemic coronary disease
- History of percutaneous coronary intervention
- Cerebrovascular diseases or peripheral
- Dyslipidemia required statin therapy
- Heart failure, arrhythmogenic right ventricular dysplasia, hypertrophic cardiomyopathy, akinesia or aneurysm on left ventricular wall, anomaly of coronary artery
- NYHA III and IV
Show all 11Show fewer
- Arrhythmia
- Primary cardiac electrical diseases
- Cardiac pacemaker or implantable defibrillator
- Pregnancy or breast feeding
- Life expectancy less than 2 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study of Statin Therapy In Patients With Vasospastic Angina
The purpose of this study is to evaluate whether statin is effective in the treatment of vasospastic angina.
- Conditions
- Angina Pectoris, Variant, Statins, HMG-CoA
- Being tested
- Atorvastatin, Placebo
- Keywords
- statin, vasospastic angina
- 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
20mg QD
PlaceboDrug
Placebo drug will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Atorvastatin | Experimental | 20mg QD Receives: Drug: Atorvastatin |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Composite Event of all-cause death, myocardial infarction, angina-related hospitalization
The number of events with the first occurrence of a composite event(all-cause death, myocardial infarction, angina-related hospitalization)
Measured: 3 years
Secondary outcomes (8)
all-cause death
Measured: 3 years
cardiac death
Measured: 3 years
cardiac arrest
Measured: 3 years
myocardial infarction
Measured: 3 years
angina-related hospitalization
Measured: 3 years
Composite event of death or myocardial infarction
Measured: 3 years
Composite event of cardiac death or myocardial infarction
Measured: 3 years
statin-related complications
event rate of statin-related complications
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2016 (estimated)
- Study startJul 2017 (estimated)
- Primary completionJun 2023 (estimated)
- Study completionDec 2023 (estimated)
Why it stopped: Funding issue
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.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seung-Jung Park
- Sponsor type
- University, hospital or other
- Collaborators
- CardioVascular Research Foundation, Korea
- Responsible party
- Sponsor-investigator, Seung-Jung Park, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02790528
- Sponsor's protocol ID
- AMCCV2016-11
- Acronym
- STAVA
- Status last verified
- Jun 2017
- First submitted
- 26 May 2016
- Last updated
- 15 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is not a publicly funded trial.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study of Statin Therapy In Patients With Vasospastic Angina
- ClinicalTrials.gov ID
- NCT02790528
- Acronym / sponsor ID
- STAVA / AMCCV2016-11
- Conditions
- Angina Pectoris, Variant, Statins, HMG-CoA
- Keywords
- statin, vasospastic angina
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding issue
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Seung-Jung ParkUniversity, hospital or other
- Collaborators
- CardioVascular Research Foundation, Korea
- Study start
- Jul 2017 (estimated)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 6 Jun 2016 (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 purpose of this study is to evaluate whether statin is effective in the treatment of vasospastic angina.
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 |
|---|---|---|
| Atorvastatin | Experimental | Drug: Atorvastatin20mg QD |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 19 and more
- Vasospastic angina
- LDL less than 160mg/dl
- Written consent
Key exclusion criteria (11 listed)
- Coronary artery stenosis more than 50% or ischemic coronary disease
- History of percutaneous coronary intervention
- Cerebrovascular diseases or peripheral
- Dyslipidemia required statin therapy
- Heart failure, arrhythmogenic right ventricular dysplasia, hypertrophic cardiomyopathy, akinesia or aneurysm on left ventricular wall, anomaly of coronary artery
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 |
|---|---|---|
| Atorvastatin20mg QD | Drug | Atorvastatin |
| PlaceboPlacebo drug will be administered. | Drug | Placebo |
Primary outcome
The Composite Event of all-cause death, myocardial infarction, angina-related hospitalization
Time frame: 3 years
The number of events with the first occurrence of a composite event(all-cause death, myocardial infarction, angina-related hospitalization)
8 secondary outcomes
all-cause death
Time frame: 3 years
cardiac death
Time frame: 3 years
cardiac arrest
Time frame: 3 years
myocardial infarction
Time frame: 3 years
angina-related hospitalization
Time frame: 3 years
Composite event of death or myocardial infarction
Time frame: 3 years
Composite event of cardiac death or myocardial infarction
Time frame: 3 years
statin-related complications
Time frame: 3 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2017.
- Individual participant dataSharing planned: No. This is not a publicly funded trial.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Statins, HMG-CoA, run by Seung-Jung Park 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 4 inclusion and 11 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: withdrawn, as of the sponsor's last update on 15 Jun 2017. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
The Composite Event of all-cause death, myocardial infarction, angina-related hospitalization (time frame: 3 years). 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 15 Jun 2017.