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

September 10, 2015 updated by: Woong Chol Kang, Gachon University Gil Medical Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

99

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Incheon, Korea, Republic of, 405-760
        • Gachon University Gil Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Carvedilol
Carvedilol 25 mg twice a day
Drug: Carvedilol
Active Comparator: Atenolol
Atenolol 50 mg twice a day
Drug: Atenolol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
After 25 weeks of treatment
Time to onset of angina
Time Frame: After 25 weeks of treatment
Time to onset of angina at exercise treadmill test
After 25 weeks of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
After 25 weeks of treatment
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
After 25 weeks of treatment
Lipid profiles
Time Frame: After 25 weeks of treatment
Lipid profiles: total cholesterol, triglyceride, high-density lipoprotein-cholesterol, and low-density lipoprotein-cholesterol
After 25 weeks of treatment
Glucose metabolism
Time Frame: After 25 weeks of treatment
Fasting glucose, insulin, HbA1c, Quantitative Insulin-Sensitivity Check Index (QUICKI)
After 25 weeks of treatment
Seattle Angina Questionnaire (SAQ) scores
Time Frame: After 25 weeks of treatment
After 25 weeks of treatment
Treatment-emergent adverse events
Time Frame: After 25 weeks of treatment
After 25 weeks of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gachon University Gil Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

September 9, 2015

First Submitted That Met QC Criteria

September 10, 2015

First Posted (Estimate)

September 11, 2015

Study Record Updates

Last Update Posted (Estimate)

September 11, 2015

Last Update Submitted That Met QC Criteria

September 10, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CARVEDILOL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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