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Completed

NCT Number: NCT02547597

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

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.

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Key information

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Gachon University Gil Medical Center

Incheon, 405-760, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Carvedilol

Drug

Atenolol

Drug

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Gachon University Gil Medical Center

Other

Registry information

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Sep 11, 2015
Registry last updated
Sep 11, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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