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Comparison of Carvedilol and Atenolol on Anti-anginal and Metabolic Effects in Patients With Stable Angina Pectoris

Primary Purpose

Stable Angina Pectoris

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Carvedilol
Atenolol
Sponsored by
Gachon University Gil Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stable Angina Pectoris focused on measuring Beta-blockers, Anti-anginal effect, Lipid metabolism, Glucose metabolism

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Stable angina pectoris who had a positive exercise treadmill test according to the American College of Cardiology Foundation and the American Heart Association guidelines

Exclusion Criteria:

  • 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

Sites / Locations

  • Gachon University Gil Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Carvedilol

Atenolol

Arm Description

Carvedilol 25 mg twice a day

Atenolol 50 mg twice a day

Outcomes

Primary Outcome Measures

Time to 1-mm ST-segment depression
Time to 1-mm ST-segment depression at exercise treadmill test
Time to onset of angina
Time to onset of angina at exercise treadmill test

Secondary Outcome Measures

Blood pressure at resting and peak exercise
Blood pressure at resting and peak exercise during exercise treadmill test
Heart rate at resting and peak exercise
Heart rate at resting and peak exercise during exercise treadmill test
Lipid profiles
Lipid profiles: total cholesterol, triglyceride, high-density lipoprotein-cholesterol, and low-density lipoprotein-cholesterol
Glucose metabolism
Fasting glucose, insulin, HbA1c, Quantitative Insulin-Sensitivity Check Index (QUICKI)
Seattle Angina Questionnaire (SAQ) scores
Treatment-emergent adverse events

Full Information

First Posted
September 9, 2015
Last Updated
September 10, 2015
Sponsor
Gachon University Gil Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02547597
Brief Title
Comparison of Carvedilol and Atenolol on Anti-anginal and Metabolic Effects in Patients With Stable Angina Pectoris
Official Title
Comparison of Carvedilol and Atenolol on Anti-anginal and Metabolic Effects in Patients With Stable Angina Pectoris
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gachon University Gil Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stable Angina Pectoris
Keywords
Beta-blockers, Anti-anginal effect, Lipid metabolism, Glucose metabolism

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
99 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Carvedilol
Arm Type
Experimental
Arm Description
Carvedilol 25 mg twice a day
Arm Title
Atenolol
Arm Type
Active Comparator
Arm Description
Atenolol 50 mg twice a day
Intervention Type
Drug
Intervention Name(s)
Carvedilol
Intervention Type
Drug
Intervention Name(s)
Atenolol
Primary Outcome Measure Information:
Title
Time to 1-mm ST-segment depression
Description
Time to 1-mm ST-segment depression at exercise treadmill test
Time Frame
After 25 weeks of treatment
Title
Time to onset of angina
Description
Time to onset of angina at exercise treadmill test
Time Frame
After 25 weeks of treatment
Secondary Outcome Measure Information:
Title
Blood pressure at resting and peak exercise
Description
Blood pressure at resting and peak exercise during exercise treadmill test
Time Frame
After 25 weeks of treatment
Title
Heart rate at resting and peak exercise
Description
Heart rate at resting and peak exercise during exercise treadmill test
Time Frame
After 25 weeks of treatment
Title
Lipid profiles
Description
Lipid profiles: total cholesterol, triglyceride, high-density lipoprotein-cholesterol, and low-density lipoprotein-cholesterol
Time Frame
After 25 weeks of treatment
Title
Glucose metabolism
Description
Fasting glucose, insulin, HbA1c, Quantitative Insulin-Sensitivity Check Index (QUICKI)
Time Frame
After 25 weeks of treatment
Title
Seattle Angina Questionnaire (SAQ) scores
Time Frame
After 25 weeks of treatment
Title
Treatment-emergent adverse events
Time Frame
After 25 weeks of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Stable angina pectoris who had a positive exercise treadmill test according to the American College of Cardiology Foundation and the American Heart Association guidelines Exclusion Criteria: 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
Facility Information:
Facility Name
Gachon University Gil Medical Center
City
Incheon
ZIP/Postal Code
405-760
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
27021556
Citation
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.
Results Reference
derived

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Comparison of Carvedilol and Atenolol on Anti-anginal and Metabolic Effects in Patients With Stable Angina Pectoris

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