Variant AnginaPhase 4NCT01674686
The Effect of Sarpogrelate and High Dose Statin on the Reduction of Coronary Spasm
A Phase 4 study testing Sarpogrelate and Atorvastatin in people with Variant Angina, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The aim of the study was to to evaluate the effect of sarpogrelate, a selective serotonin receptor antagonist, and high dose statin on the reduction of coronary spasm in the patients with variant angina. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Variant Angina
- What is being tested?
- Sarpogrelate and Atorvastatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Aug 2012to 31 Dec 2018
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical history of chest pain compatible with variant angina; morning chest pain aggravated by cold exposure.
- Angiographically proven coronary spasm; TIMI flow < 3 by spontaneous coronary spasm or intracoronary ergonovine spasm provocation test.
Who cannot join
- Cardiac arrest by coronary spasm
- Left main coronary spasm
- Significant fixed coronary artery stenosis; Diameter stenosis > 70% in the major epicardial artery by coronary angiography
- Left ventricular ejection fraction < 30%
- Coagulation disorders or bleeding tendency (Platelet count < 50k, PT INR > 2.0)
- Significant liver disease (AST or ALT > 100 U/ml)
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- Renal failure (S-Cr > 2.0 mg/dl)
- hypersensitivity for statin
- Pregnancy
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Hyoen-Cheol Gwon, MD,PhD
Seoul, 135-710
Hyoen-Cheol Gwon, MD,PhD, 82-2-3410-3418, hcgwon@skku.edu
About this study
Official title: A Prospective, Single-center, Randomized Study to Evaluate the Effect of Sarpogrelate, a Selective Serotonin Receptor Antagonist, and High Dose Statin on the Reduction of Coronary Spasm in the Patients With Variant Angina
The aim of the study was to to evaluate the effect of sarpogrelate, a selective serotonin receptor antagonist, and high dose statin on the reduction of coronary spasm in the patients with variant angina.
- Conditions
- Variant Angina
- Being tested
- Sarpogrelate, Atorvastatin
- Keywords
- Vasospasm, Sarpogrelate, Statin
- 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.
SarpogrelateDrug
Sarpogrelate 100mg twice a day
AtorvastatinDrug
Atorvastatin 80mg daily
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Sarpogrelate versus placebo Receives: Drug: Sarpogrelate |
| B | Experimental | Atorvastatin 80mg versus no statin or simvastatin 20 mg if LDL > 130 mg/dl Receives: Drug: Atorvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ergonovine provocation test 12months later
Measured: 1 year later
Secondary outcomes (1)
C-reactive protein lever 12months later
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2012 (estimated)
- Study start1 Aug 2012
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Variant AnginaStudies 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
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyeon-Cheol Gwon, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01674686
- Sponsor's protocol ID
- 2011-12-069
- Status last verified
- Feb 2018
- First submitted
- 24 Aug 2012
- Last updated
- 9 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-center, Randomized Study to Evaluate the Effect of Sarpogrelate, a Selective Serotonin Receptor Antagonist, and High Dose Statin on the Reduction of Coronary Spasm in the Patients With Variant Angina
- ClinicalTrials.gov ID
- NCT01674686
- Acronym / sponsor ID
- 2011-12-069
- Conditions
- Variant Angina
- Keywords
- Vasospasm, Sarpogrelate, Statin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 1 Aug 2012 (actual)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 29 Aug 2012 (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 the study was to to evaluate the effect of sarpogrelate, a selective serotonin receptor antagonist, and high dose statin on the reduction of coronary spasm in the patients with variant angina.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: SarpogrelateSarpogrelate versus placebo |
| B | Experimental | Drug: AtorvastatinAtorvastatin 80mg versus no statin or simvastatin 20 mg if LDL > 130 mg/dl |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical history of chest pain compatible with variant angina; morning chest pain aggravated by cold exposure.
- Angiographically proven coronary spasm; TIMI flow < 3 by spontaneous coronary spasm or intracoronary ergonovine spasm provocation test.
Key exclusion criteria (9 listed)
- Cardiac arrest by coronary spasm
- Left main coronary spasm
- Significant fixed coronary artery stenosis; Diameter stenosis > 70% in the major epicardial artery by coronary angiography
- Left ventricular ejection fraction < 30%
- Coagulation disorders or bleeding tendency (Platelet count < 50k, PT INR > 2.0)
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 |
|---|---|---|
| SarpogrelateSarpogrelate 100mg twice a day | Drug | A |
| AtorvastatinAtorvastatin 80mg daily | Drug | B |
Primary outcome
Ergonovine provocation test 12months later
Time frame: 1 year later
1 secondary outcome
C-reactive protein lever 12months later
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2018.
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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.
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 Sarpogrelate and Atorvastatin in people with Variant Angina, 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 9 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 9 Feb 2018. 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 Hyeon-Cheol Gwon, MD,PhD (82-2-3410-3419, hcgwon@skku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ergonovine provocation test 12months later (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 9 Feb 2018.