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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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ClinicalTrials.gov Identifier: NCT02547597
Recruitment Status : Completed
First Posted : September 11, 2015
Last Update Posted : September 11, 2015
Sponsor:
Information provided by (Responsible Party):
Woong Chol Kang, Gachon University Gil Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Stable Angina Pectoris Drug: Carvedilol Drug: Atenolol Phase 4

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 99 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Carvedilol and Atenolol on Anti-anginal and Metabolic Effects in Patients With Stable Angina Pectoris
Study Start Date : April 2011
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angina

Arms and Interventions
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Arm Intervention/treatment
Experimental: Carvedilol
Carvedilol 25 mg twice a day
 Drug: Carvedilol
Active Comparator: Atenolol
Atenolol 50 mg twice a day
 Drug: Atenolol


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. Time to onset of angina [ Time Frame: After 25 weeks of treatment ]
    Time to onset of angina at exercise treadmill test


Secondary Outcome Measures :
  1. Blood pressure at resting and peak exercise [ Time Frame: After 25 weeks of treatment ]
    Blood pressure at resting and peak exercise during exercise treadmill test

  2. Heart rate at resting and peak exercise [ Time Frame: After 25 weeks of treatment ]
    Heart rate at resting and peak exercise during exercise treadmill test

  3. Lipid profiles [ Time Frame: After 25 weeks of treatment ]
    Lipid profiles: total cholesterol, triglyceride, high-density lipoprotein-cholesterol, and low-density lipoprotein-cholesterol

  4. Glucose metabolism [ Time Frame: After 25 weeks of treatment ]
    Fasting glucose, insulin, HbA1c, Quantitative Insulin-Sensitivity Check Index (QUICKI)

  5. Seattle Angina Questionnaire (SAQ) scores [ Time Frame: After 25 weeks of treatment ]
  6. Treatment-emergent adverse events [ Time Frame: After 25 weeks of treatment ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02547597


Locations
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Korea, Republic of
Gachon University Gil Medical Center
Incheon, Korea, Republic of, 405-760
Sponsors and Collaborators
Gachon University Gil Medical Center
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Woong Chol Kang, Associate professor, Gachon University Gil Medical Center
ClinicalTrials.gov Identifier: NCT02547597    
Other Study ID Numbers: CARVEDILOL
First Posted: September 11, 2015    Key Record Dates
Last Update Posted: September 11, 2015
Last Verified: September 2015
Keywords provided by Woong Chol Kang, Gachon University Gil Medical Center:
Beta-blockers
Anti-anginal effect
Lipid metabolism
Glucose metabolism
Additional relevant MeSH terms:
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Angina Pectoris
Angina, Stable
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Neurologic Manifestations
Atenolol
Carvedilol
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
 Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antihypertensive Agents
Antioxidants
Protective Agents
Calcium Channel Blockers
Membrane Transport Modulators
Calcium-Regulating Hormones and Agents
Vasodilator Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Anti-Arrhythmia Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents