NCT02547597

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
99

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Apr 2011

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 11, 2015

Completed
Last Updated

September 11, 2015

Status Verified

September 1, 2015

Enrollment Period

2.3 years

First QC Date

September 9, 2015

Last Update Submit

September 10, 2015

Conditions

Stable Angina Pectoris

Keywords

Beta-blockersAnti-anginal effectLipid metabolismGlucose metabolism

Outcome Measures

Primary Outcomes (2)

  • Time to 1-mm ST-segment depression

    Time to 1-mm ST-segment depression at exercise treadmill test

    After 25 weeks of treatment

  • Time to onset of angina

    Time to onset of angina at exercise treadmill test

    After 25 weeks of treatment

Secondary Outcomes (6)

  • Blood pressure at resting and peak exercise

    After 25 weeks of treatment

  • Heart rate at resting and peak exercise

    After 25 weeks of treatment

  • Lipid profiles

    After 25 weeks of treatment

  • Glucose metabolism

    After 25 weeks of treatment

  • Seattle Angina Questionnaire (SAQ) scores

    After 25 weeks of treatment

  • +1 more secondary outcomes

Study Arms (2)

Carvedilol

EXPERIMENTAL

Carvedilol 25 mg twice a day

Drug: Carvedilol

Atenolol

ACTIVE COMPARATOR

Atenolol 50 mg twice a day

Drug: Atenolol

Interventions

CarvedilolDRUG
Carvedilol
AtenololDRUG
Atenolol

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Stable angina pectoris who had a positive exercise treadmill test according to the American College of Cardiology Foundation and the American Heart Association guidelines

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gachon University Gil Medical Center

Incheon, 405-760, South Korea

Location

Related Publications (1)

  • Oh PC, Kang WC, Moon J, Park YM, Kim S, Kim MG, Lee K, Ahn T, Shin EK. Anti-Anginal and Metabolic Effects of Carvedilol and Atenolol in Patients with Stable Angina Pectoris: A Prospective, Randomized, Parallel, Open-Label Study. Am J Cardiovasc Drugs. 2016 Jun;16(3):221-8. doi: 10.1007/s40256-016-0168-1.

    PMID: 27021556DERIVED

MeSH Terms

Conditions

Angina, Stable

Interventions

CarvedilolAtenolol

Condition Hierarchy (Ancestors)

Angina PectorisMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesCarbazolesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHeterocyclic Compounds, 3-RingPhenoxypropanolamines

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

September 9, 2015

First Posted

September 11, 2015

Study Start

April 1, 2011

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

September 11, 2015

Record last verified: 2015-09

Locations

KR(1)