Coronary Artery DiseasePhase 4SAGE-CADNCT02607436
Effect of Sarpogrelate, a Serotonin Receptor Antagonist, on Coronary Artery Disease
A Phase 4 study testing Sarpogrelate and Aspirin in people with Coronary Artery Disease, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
This is a prospective interventional study to assess the effect of sarpogrelate compared with aspirin in Korean type 2 diabetic patients with atherosclerosis. Read more about this study
- Who is it for?
- Ages 30 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Sarpogrelate and Aspirin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2015to Apr 2016
- 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 30 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Type 2 diabetes with HbA1c ≥ 6.5% at screening visit
- Male or female between 30 and 80 years of age
- Coronary artery stenosis: 10-75% without no evidence of acute coronary syndrome
- No history of previous myocardial infarction
Who cannot join
- Systolic blood pressure / diastolic blood pressure > 160/110 mmHg
- Congestive heart failure
- Allergy to radiocontrast dye
- Allergy to aspirin or sarpogrelate
- Acute bleeding
- History of ulcer bleeding
- GOT/GPT > 100/100
- Other antiplatelet medication
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
About this study
Official title: Effect of Sarpogrelate, a Serotonin Receptor Antagonist, on Progression of Coronary Artery Disease
This is a prospective interventional study to assess the effect of sarpogrelate compared with aspirin in Korean type 2 diabetic patients with atherosclerosis.
Read the detailed description
Type 2 diabetes has been increased exponentially, arousing serious economic, social and health repercussions. Also, macrovascular complications of diabetes such as myocardial infarct or stroke have been increased. Individuals with diabetes have a greater risk of cardiovascular disease (CVD), approximately two to four times than that of those without diabetes. Currently, the U.S. Food and Drug Administration requires demonstration that new anti-hyperglycemic agents do not increase cardiovascular risk. The comprehensive and multifactorial management in type 2 diabetes, which includes control of hypertension, dyslipidemia and obesity, is known to significantly reduce the risk of CVD as shown in Steno-2 study. However, most anti-diabetic agents currently used in clinical practice do not seem to provide enough cardiovascular protection.
- Conditions
- Coronary Artery Disease
- Being tested
- Sarpogrelate, Aspirin
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SarpogrelateDrug
Also called Anplag
Sarpogrelate
AspirinDrug
Also called Aspirin protect or Astrix
Aspirin
| Study group | Role | What they receive |
|---|---|---|
| Sarpogrelate + Aspirin | Experimental | Sarpogrelate as an active drug Receives: Drug: Sarpogrelate; Drug: Aspirin |
| Aspirin alone | Active comparator | Aspirin as an active comparator Receives: Drug: Aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coronary artery disease assessed by cardiac computed tomography angiography
Measured: 6 months
Secondary outcomes (8)
Coronary artery calcium score assessed by cardiac computed tomography angiography
Measured: 6 months
Coronary artery stenosis assessed by cardiac computed tomography angiography
Measured: 6 months
Changes of plaque size assessed by cardiac computed tomography angiography
Measured: 6 months
Changes of plaque composition assessed by cardiac computed tomography angiography
Measured: 6 months
Changes of Ankle-branchial index
Measured: 6 months
Changes of pulse wave velocity
Measured: 6 months
Glucose metabolism assessed by glycated hemoglobin
Measured: 6 months
Lipid metabolism assessed by triglyceride and high density lipoprotein-cholesterol
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2015 (estimated)
- Study startJul 2015
- Primary completionFeb 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Soo Lim, Seoul National University Bundang Hospital
- Investigators
- Soo Lim, MD, PhD, Principal investigator, SNUBH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02607436
- Sponsor's protocol ID
- B-1111/139-007
- Acronym
- SAGE-CAD
- Status last verified
- May 2016
- First submitted
- 12 Nov 2015
- Last updated
- 3 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sarpogrelate, a Serotonin Receptor Antagonist, on Progression of Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT02607436
- Acronym / sponsor ID
- SAGE-CAD / B-1111/139-007
- Conditions
- Coronary Artery Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 18 Nov 2015 (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 is a prospective interventional study to assess the effect of sarpogrelate compared with aspirin in Korean type 2 diabetic patients with atherosclerosis.
Detailed description
Type 2 diabetes has been increased exponentially, arousing serious economic, social and health repercussions. Also, macrovascular complications of diabetes such as myocardial infarct or stroke have been increased. Individuals with diabetes have a greater risk of cardiovascular disease (CVD), approximately two to four times than that of those without diabetes. Currently, the U.S. Food and Drug Administration requires demonstration that new anti-hyperglycemic agents do not increase cardiovascular risk. The comprehensive and multifactorial management in type 2 diabetes, which includes control of hypertension, dyslipidemia and obesity, is known to significantly reduce the risk of CVD as shown in Steno-2 study. However, most anti-diabetic agents currently used in clinical practice do not seem to provide enough cardiovascular protection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sarpogrelate + Aspirin | Experimental | Drug: Sarpogrelate, Drug: AspirinSarpogrelate as an active drug |
| Aspirin alone | Active comparator | Drug: AspirinAspirin as an active comparator |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Type 2 diabetes with HbA1c ≥ 6.5% at screening visit
- Male or female between 30 and 80 years of age
- Coronary artery stenosis: 10-75% without no evidence of acute coronary syndrome
- No history of previous myocardial infarction
Key exclusion criteria (8 listed)
- Systolic blood pressure / diastolic blood pressure > 160/110 mmHg
- Congestive heart failure
- Allergy to radiocontrast dye
- Allergy to aspirin or sarpogrelate
- Acute bleeding
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 |
|---|---|---|
| SarpogrelateAlso: AnplagSarpogrelate | Drug | Sarpogrelate + Aspirin |
| AspirinAlso: Aspirin protect or AstrixAspirin | Drug | Aspirin alone, Sarpogrelate + Aspirin |
Primary outcome
Coronary artery disease assessed by cardiac computed tomography angiography
Time frame: 6 months
8 secondary outcomes
Coronary artery calcium score assessed by cardiac computed tomography angiography
Time frame: 6 months
Coronary artery stenosis assessed by cardiac computed tomography angiography
Time frame: 6 months
Changes of plaque size assessed by cardiac computed tomography angiography
Time frame: 6 months
Changes of plaque composition assessed by cardiac computed tomography angiography
Time frame: 6 months
Changes of Ankle-branchial index
Time frame: 6 months
Changes of pulse wave velocity
Time frame: 6 months
Glucose metabolism assessed by glycated hemoglobin
Time frame: 6 months
Lipid metabolism assessed by triglyceride and high density lipoprotein-cholesterol
Time frame: 6 months
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 3 May 2016.
- Individual participant dataSharing planned: No
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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.
Soo Lim, MD, PhD principal investigator
SNUBH
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 Aspirin in people with Coronary Artery Disease, run by Seoul National University Bundang Hospital 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 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: finished, as of the sponsor's last update on 3 May 2016. 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?
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?
Coronary artery disease assessed by cardiac computed tomography angiography (time frame: 6 months). 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 3 May 2016.