Stable AnginaPhase 4NCT01162902
Comparison of Vascular Remodeling Between Different Antianginal Medication Evaluated by Noninvasive ECG-gated Fundus Photographic Evaluation
A Phase 4 study testing Diltiazem treated group, Bisoprolol treated group and Candesartan treated group in people with Stable Angina, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Treatments for stable angina includes drug therapy such as calcium-channel blocker, beta blocker, and ACEI/ARB. To obtain good prognosis in patients with coronary artery disease,preventing or correcting the progression of atherosclerosis and dyslipidemia is more important than relieving angina symptom. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Stable Angina
- What is being tested?
- Diltiazem treated group, Bisoprolol treated group and Candesartan treated group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2013to Dec 2015
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stable angina patients whose coronary lesions is confirmed by angiography or receives PCI
- Unstable Angina/NSTEMI patients who completed PCI for main lesions
- Either systolic > 130mmHg or diastolic > 80mmHg, or patients with anti-hypertensive drugs
Who cannot join
- STEMI patients within one month
- Variant Angina
- Liver function abnormality or renal failure
- History of Hypersensitivity to testing drugs
- Severe heart failure(NYHA class>3) or uncorrectable hematologic disease
- Woman possible to be pregnant
- Uncontrolled diabetes
- Expected life span < one year
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Hospital
Seoul
Hyo-Soo Kim, MD, PhD
Hae-Young Lee, MD,PhD
About this study
Treatments for stable angina includes drug therapy such as calcium-channel blocker, beta blocker, and ACEI/ARB. To obtain good prognosis in patients with coronary artery disease,preventing or correcting the progression of atherosclerosis and dyslipidemia is more important than relieving angina symptom. Dysfunction of microvessel is one of the most important factor in patients with coronary artery disease. Recently, we developed the new non-invasive method of evaluating the microvessel in fundus. With this methods, we will compare the effect of each drug (beta blocker, CCB, ARB).
- Conditions
- Stable Angina
- Being tested
- Diltiazem treated group, Bisoprolol treated group, Candesartan treated group
- Medical subject headings
- Angina, Stable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diltiazem treated groupDrug
Diltiazem 180mg for 9 months
Bisoprolol treated groupDrug
Bisoprolol 5mg for 9 months
Candesartan treated groupDrug
Candesartan 32mg for 9 months
| Study group | Role | What they receive |
|---|---|---|
| Diltiazem treated group | Experimental | Diltiazem 180mg treated group Receives: Drug: Diltiazem treated group |
| Bisoprolol treated group | Active comparator | Bisoprolol 5mg treated group Receives: Drug: Bisoprolol treated group |
| Candesartan treated group | Active comparator | Candesartan 32mg treated group Receives: Drug: Candesartan treated group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wall to lumen ratio of fundus vessel
Measurement of change in the ratio of wall thickness to lumen of the fundus vessel from baseline to 9 month follow up
Measured: baseline, 9 months
Secondary outcomes (3)
lipid parameter
Measurement of change in total cholesterol, triglyceride, LDL, small dense LDL, and HDL
Measured: baseline, 9 months
Serum markers of inflammation
CRP
Measured: baseline, 9 months
Change of nitrate need
Measure of change of nitrate need
Measured: baseline, 1 months, and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2010 (estimated)
- Study startSep 2013
- Primary completionJan 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stable AnginaStudies of the same condition, open and under way.
- More trials run by Seoul National University 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01162902
- Sponsor's protocol ID
- ABC Trial
- Status last verified
- Dec 2013
- First submitted
- 30 Apr 2010
- Last updated
- 17 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Vascular Remodeling Between Different Antianginal Medication Evaluated by Noninvasive ECG-gated Fundus Photographic Evaluation
- ClinicalTrials.gov ID
- NCT01162902
- Acronym / sponsor ID
- ABC Trial
- Conditions
- Stable Angina
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Jan 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 15 Jul 2010 (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.
Treatments for stable angina includes drug therapy such as calcium-channel blocker, beta blocker, and ACEI/ARB. To obtain good prognosis in patients with coronary artery disease,preventing or correcting the progression of atherosclerosis and dyslipidemia is more important than relieving angina symptom. Dysfunction of microvessel is one of the most important factor in patients with coronary artery disease. Recently, we developed the new non-invasive method of evaluating the microvessel in fundus. With this methods, we will compare the effect of each drug (beta blocker, CCB, ARB).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Diltiazem treated group | Experimental | Drug: Diltiazem treated groupDiltiazem 180mg treated group |
| Bisoprolol treated group | Active comparator | Drug: Bisoprolol treated groupBisoprolol 5mg treated group |
| Candesartan treated group | Active comparator | Drug: Candesartan treated groupCandesartan 32mg treated group |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Stable angina patients whose coronary lesions is confirmed by angiography or receives PCI
- Unstable Angina/NSTEMI patients who completed PCI for main lesions
- Either systolic > 130mmHg or diastolic > 80mmHg, or patients with anti-hypertensive drugs
Key exclusion criteria (8 listed)
- STEMI patients within one month
- Variant Angina
- Liver function abnormality or renal failure
- History of Hypersensitivity to testing drugs
- Severe heart failure(NYHA class>3) or uncorrectable hematologic disease
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 |
|---|---|---|
| Diltiazem treated groupDiltiazem 180mg for 9 months | Drug | Diltiazem treated group |
| Bisoprolol treated groupBisoprolol 5mg for 9 months | Drug | Bisoprolol treated group |
| Candesartan treated groupCandesartan 32mg for 9 months | Drug | Candesartan treated group |
Primary outcome
Wall to lumen ratio of fundus vessel
Time frame: baseline, 9 months
Measurement of change in the ratio of wall thickness to lumen of the fundus vessel from baseline to 9 month follow up
3 secondary outcomes
lipid parameter
Time frame: baseline, 9 months
Serum markers of inflammation
Time frame: baseline, 9 months
Change of nitrate need
Time frame: baseline, 1 months, and 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2013.
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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 Diltiazem treated group, Bisoprolol treated group and Candesartan treated group in people with Stable Angina, run by Seoul National University 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 3 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 17 Dec 2013. 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 Hae-Young Lee, MD, PhD (82-10-4528-6160, hylee612@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wall to lumen ratio of fundus vessel (time frame: baseline, 9 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 17 Dec 2013.