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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02547597
Other study ID # CARVEDILOL
Secondary ID
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


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
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