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

Stable Angina Pectoris Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02547597
• Other study ID #: CARVEDILOL
• Status: Completed
• Phase: Phase 4
• First received: September 9, 2015
• Last updated: September 10, 2015
• Start date: April 2011
• Est. completion date: August 2013

Study information

• Verified date: September 2015
• Source: Gachon University Gil Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical 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. Therefore, the investigators compared carvedilol and atenolol on anti-anginal and metabolic effects in patient with stable angina pectoris.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Angina Pectoris
• Angina, Stable
• Stable Angina Pectoris

Intervention

Drug:
• Carvedilol

• Atenolol

Locations

Country	Name	City	State
Korea, Republic of	Gachon University Gil Medical Center	Incheon

Sponsors (1)

Lead Sponsor	Collaborator
Gachon University Gil Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to 1-mm ST-segment depression	Time to 1-mm ST-segment depression at exercise treadmill test	After 25 weeks of treatment	No
Primary	Time to onset of angina	Time to onset of angina at exercise treadmill test	After 25 weeks of treatment	No
Secondary	Blood pressure at resting and peak exercise	Blood pressure at resting and peak exercise during exercise treadmill test	After 25 weeks of treatment	No
Secondary	Heart rate at resting and peak exercise	Heart rate at resting and peak exercise during exercise treadmill test	After 25 weeks of treatment	No
Secondary	Lipid profiles	Lipid profiles: total cholesterol, triglyceride, high-density lipoprotein-cholesterol, and low-density lipoprotein-cholesterol	After 25 weeks of treatment	No
Secondary	Glucose metabolism	Fasting glucose, insulin, HbA1c, Quantitative Insulin-Sensitivity Check Index (QUICKI)	After 25 weeks of treatment	No
Secondary	Seattle Angina Questionnaire (SAQ) scores		After 25 weeks of treatment	No
Secondary	Treatment-emergent adverse events		After 25 weeks of treatment	Yes