Stable Angina PectorisPhase 4NCT02547597
Comparison of Carvedilol and Atenolol on Anti-anginal and Metabolic Effects in Patients With Stable Angina Pectoris
A Phase 4 study testing Carvedilol and Atenolol in people with Stable Angina Pectoris, run by Gachon University Gil Medical Center at 1 site in South Korea.
Trial summary
There are few data regarding anti-anginal effects between beta-blockers with and without vasodilating property. Beta-blocker without vasodilating property is generally known to have unfavorable effects on glucose and lipid metabolism. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Stable Angina Pectoris
- What is being tested?
- Carvedilol and Atenolol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2011to Aug 2013
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stable angina pectoris who had a positive exercise treadmill test according to the American College of Cardiology Foundation and the American Heart Association guidelines
Who cannot join
- Acute coronary syndrome
- Coronary revascularization within the past 3 months
- Asthma or chronic obstructive lung disease
- Bradycardia (heart rate < 55 beat/min)
- History of severe adverse reaction to beta-blockers
- Symptomatic arrhythmia requiring anti-arrhythmia therapy
- Heart failure
- Severe renal or hepatic failure
Trial locations and contacts
1 site in 1 country.
About this study
There are few data regarding anti-anginal effects between beta-blockers with and without vasodilating property. Beta-blocker without vasodilating property is generally known to have unfavorable effects on glucose and lipid metabolism. Therefore, the investigators compared carvedilol and atenolol on anti-anginal and metabolic effects in patient with stable angina pectoris.
Read the detailed description
Previous studies have demonstrated that beta-blockers are effective in reducing not only ischemia but also cardiovascular mortality following myocardial infarction. And, recent guidelines have suggested the potential for use of beta-blockers as first-line agents in chronic stable angina. However, beta-blockers are a diverse class with different mechanisms of action and physiological effects. Various pharmacologic properties that characterize beta-blockers include cardioselectivity, intrinsic sympathomimetic activity, and concomitant vasodilating alpha-adrenoceptor blockade, which might exhibit differential anti-anginal efficacies. In addition, traditional beta-blockers, particularly nonvasodilating beta-blockers, have been reported to have negative metabolic effects, including hyperglycemia, insulin resistance, and dyslipidemia. These unfavorable effects of beta-blockers should be considered in patients with stable angina pectoris, because the pathophysiology of coronary artery disease is associated with abnormalities in glucose and lipid metabolism. Carvedilol, a newer vasodilating beta-blocker, has been shown to differ from traditional beta-blockers in terms of metabolic effects in patients with hypertension and diabetes. However, few data regarding comparative anti-anginal and metabolic effects between beta-blockers with and without vasodilating property have been reported, particularly in patients with angina pectoris. In this study, we simultaneously compared anti-anginal and metabolic effects of carvedilol and atenolol in patients with stable angina pectoris.
- Conditions
- Stable Angina Pectoris
- Being tested
- Carvedilol, Atenolol
- Keywords
- Beta-blockers, Anti-anginal effect, Lipid metabolism, Glucose metabolism
- Medical subject headings
- Angina, Stable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarvedilolDrug
AtenololDrug
| Study group | Role | What they receive |
|---|---|---|
| Carvedilol | Experimental | Carvedilol 25 mg twice a day Receives: Drug: Carvedilol |
| Atenolol | Active comparator | Atenolol 50 mg twice a day Receives: Drug: Atenolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to 1-mm ST-segment depression
Time to 1-mm ST-segment depression at exercise treadmill test
Measured: After 25 weeks of treatment
Time to onset of angina
Time to onset of angina at exercise treadmill test
Measured: After 25 weeks of treatment
Secondary outcomes (6)
Blood pressure at resting and peak exercise
Blood pressure at resting and peak exercise during exercise treadmill test
Measured: After 25 weeks of treatment
Heart rate at resting and peak exercise
Heart rate at resting and peak exercise during exercise treadmill test
Measured: After 25 weeks of treatment
Lipid profiles
Lipid profiles: total cholesterol, triglyceride, high-density lipoprotein-cholesterol, and low-density lipoprotein-cholesterol
Measured: After 25 weeks of treatment
Glucose metabolism
Fasting glucose, insulin, HbA1c, Quantitative Insulin-Sensitivity Check Index (QUICKI)
Measured: After 25 weeks of treatment
Seattle Angina Questionnaire (SAQ) scores
Measured: After 25 weeks of treatment
Treatment-emergent adverse events
Measured: After 25 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2015 (estimated)
- Study startApr 2011
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stable Angina PectorisStudies 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
- None (open label)
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gachon University Gil Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Woong Chol Kang, Gachon University Gil Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02547597
- Sponsor's protocol ID
- CARVEDILOL
- Status last verified
- Sep 2015
- First submitted
- 9 Sep 2015
- Last updated
- 11 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Oh PC, Kang WC, Moon J, Park YM, Kim S, Kim MG, Lee K, Ahn T, Shin EK. Anti-Anginal and Metabolic Effects of Carvedilol and Atenolol in Patients with Stable Angina Pectoris: A Prospective, Randomized, Parallel, Open-Label Study. Am J Cardiovasc Drugs. 2016 Jun;16(3):221-8. doi: 10.1007/s40256-016-0168-1.
PubMed 27021556
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Carvedilol and Atenolol on Anti-anginal and Metabolic Effects in Patients With Stable Angina Pectoris
- ClinicalTrials.gov ID
- NCT02547597
- Acronym / sponsor ID
- CARVEDILOL
- Conditions
- Stable Angina Pectoris
- Keywords
- Beta-blockers, Anti-anginal effect, Lipid metabolism, Glucose metabolism
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Gachon University Gil Medical CenterUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 11 Sep 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.
There are few data regarding anti-anginal effects between beta-blockers with and without vasodilating property. Beta-blocker without vasodilating property is generally known to have unfavorable effects on glucose and lipid metabolism. Therefore, the investigators compared carvedilol and atenolol on anti-anginal and metabolic effects in patient with stable angina pectoris.
Detailed description
Previous studies have demonstrated that beta-blockers are effective in reducing not only ischemia but also cardiovascular mortality following myocardial infarction. And, recent guidelines have suggested the potential for use of beta-blockers as first-line agents in chronic stable angina. However, beta-blockers are a diverse class with different mechanisms of action and physiological effects. Various pharmacologic properties that characterize beta-blockers include cardioselectivity, intrinsic sympathomimetic activity, and concomitant vasodilating alpha-adrenoceptor blockade, which might exhibit differential anti-anginal efficacies. In addition, traditional beta-blockers, particularly nonvasodilating beta-blockers, have been reported to have negative metabolic effects, including hyperglycemia, insulin resistance, and dyslipidemia. These unfavorable effects of beta-blockers should be considered in patients with stable angina pectoris, because the pathophysiology of coronary artery disease is associated with abnormalities in glucose and lipid metabolism. Carvedilol, a newer vasodilating beta-blocker, has been shown to differ from traditional beta-blockers in terms of metabolic effects in patients with hypertension and diabetes. However, few data regarding comparative anti-anginal and metabolic effects between beta-blockers with and without vasodilating property have been reported, particularly in patients with angina pectoris. In this study, we simultaneously compared anti-anginal and metabolic effects of carvedilol and atenolol in patients with stable angina pectoris.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carvedilol | Experimental | Drug: CarvedilolCarvedilol 25 mg twice a day |
| Atenolol | Active comparator | Drug: AtenololAtenolol 50 mg twice a day |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Stable angina pectoris who had a positive exercise treadmill test according to the American College of Cardiology Foundation and the American Heart Association guidelines
Key exclusion criteria (8 listed)
- Acute coronary syndrome
- Coronary revascularization within the past 3 months
- Asthma or chronic obstructive lung disease
- Bradycardia (heart rate < 55 beat/min)
- History of severe adverse reaction to beta-blockers
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 |
|---|---|---|
| Carvedilol | Drug | Carvedilol |
| Atenolol | Drug | Atenolol |
Primary outcome
Time to 1-mm ST-segment depression
Time frame: After 25 weeks of treatment
Time to 1-mm ST-segment depression at exercise treadmill test
Time to onset of angina
Time frame: After 25 weeks of treatment
Time to onset of angina at exercise treadmill test
6 secondary outcomes
Blood pressure at resting and peak exercise
Time frame: After 25 weeks of treatment
Heart rate at resting and peak exercise
Time frame: After 25 weeks of treatment
Lipid profiles
Time frame: After 25 weeks of treatment
Glucose metabolism
Time frame: After 25 weeks of treatment
Seattle Angina Questionnaire (SAQ) scores
Time frame: After 25 weeks of treatment
Treatment-emergent adverse events
Time frame: After 25 weeks of treatment
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 11 Sep 2015.
- Derived from this study: PubMed 27021556Oh PC, Kang WC, Moon J, Park YM, Kim S, Kim MG, Lee K, Ahn T, Shin EK. Anti-Anginal and Metabolic Effects of Carvedilol and Atenolol in Patients with Stable Angina Pectoris: A Prospective, Randomized, Parallel, Open-Label Study. Am J Cardiovasc Drugs. 2016 Jun;16(3):221-8. doi: 10.1007/s40256-016-0168-1.
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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 Carvedilol and Atenolol in people with Stable Angina Pectoris, run by Gachon University Gil 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 1 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 11 Sep 2015. 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?
Time to 1-mm ST-segment depression (time frame: After 25 weeks of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02547597, which also lists 1 linked publication.
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 11 Sep 2015.