To Assess the Anti-anginal Safety and Efficacy of Ivabradine in Subjects With Stable，Symptomatic Chronic Angina

NCT02623569 | Unknown Phase 2 DMC

• 1 other identifier: A130901CSPF01
• Study Type: interventional
• Target: 336
• Locations: 1 country
• Sites: 3

Brief Summary

Arms Assigned Interventions Experimental: Ivabradine Ivabradine 5 mg twice a day for first 4 weeks and 7.5mg twice a day when positive ETT and HR\>60times/min or negative ETT and HR\>80times/min of subjects. Active Comparator: Atenolol Atenolol 12.5 mg twice a day for first 4 weeks and 25mg twice a day when positive ETT and heard rate\>60times/min or negative ETT and HR \>80times/min of subjects.

Conditions

Angina Pectoris

Outcome Measures

Primary Outcomes (1)

• The primary efficacy endpoint is Change from total exercise duration in exercise tolerance test (ETT)

  Baseline and end of treatment (Week 12) .

Secondary Outcomes (4)

• Time to angina in exercise tolerance test.

  12 weeks

• Time to 1 mm ST-segment depression in exercise tolerance test

  12 weeks

• Number of angina attacks in exercise tolerance test per week

  12 weeks

• Number of sublingual nitroglycerin consumption per week

  12 weeks

Study Arms (2)

Ivabradine

EXPERIMENTAL

Ivabradine 5 mg twice a day for first 4 weeks and 7.5mg twice a day when positive ETT and HR（heard rate）\>60times/min or negative ETT and HR（heard rate）\>80times/min of subjects.

Drug: Ivabradine

Atenolol

ACTIVE COMPARATOR

Atenolol 12.5 mg twice a day for first 4 weeks and 25mg twice a day when positive ETT and HR（heard rate）\>60times/min or negative ETT and HR （heard rate）\>80times/min of subjects.

Drug: Atenolol

Interventions

Ivabradine DRUG

Not Provided

Also known as: Not Provided

Ivabradine

Atenolol DRUG

Not Provided

Also known as: Not Provided

Atenolol

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• male or female aged 18 to 75 years
• Clearly understand the study and participate in it voluntarily; the informed consent should be signed in person or by legal guardian.
• Chronic Stable Angina was confirmed by clinic over 3 months.
• Patients with clinical diagnosis of chronic stable angina and must meet one of the following conditions:
• Patients who have a history of myocardial infarction over 3 months.
• Patients who have received coronary intervention or CABG（Coronary Artery Bypass Grafting） over 6 months.
• Stenosis of more than 50% in at least one major epicardial coronary artery shown by Coronary Angiograph.
• Ischemic electrocardiogram changes：ST-segment depression ≥ 1.0 mm compared with P-R or elevate≥1.0 mm during exercise ECG Computed Tomography Angiography (CTA) showed more than 50% stenosis with typical angina symptoms
• ultrasonic cardiogram disclosed that left ventricular ejection fraction ≥50 %.
• Patients who manifested positive ETT (exercise tolerance testing) (defined as ST-segment depression ≥ 1 mm compared with at rest, with or without limiting angina) at screening.

You may not qualify if:

• Clinically significant Valvular disease, congenital heart disease, pulmonary hypertension, cerebral apoplexy, dissecting aneurysm, hypertrophic cardiomyopathy, acute myocarditis/cp.
• Patients with myocardial infarction within the preceding 3 months
• Patients have received Coronary angioplasty or CABG within the preceding 6 months.
• Patients who have severity vessels disease with left main coronary artery but have no valid treatment.
• Patients with congestive heart failure(New York Heart Association class III or IV)or acute pulmonary edema.
• Patients whose rest heart rate\< 60 bpm.
• Patients with nonrespiratory sinus arrhythmia or arrhythmia(e.g.,AVB(auriculo-ventricular block)ⅡⅢ,atrial fibrillation,atrial flutter,SSS(sick sinus syndrome)) or implantable cardiac defibrillator (ICD).
• Patient with any conditions that interfered the performance of exercise tolerance test or a history of an abnormal exercise response limited by electrocardiograph (ECG) changes.
• Patient with uncontrolled hypertension (seated systolic blood pressure (SBP）≥180 mmHg or diastolic blood pressure (DBP) ≥100 mmHg); SBP\<90 mmHg and/or DBP\<60 mmHg
• Diabetic with uncontrolled blood glucose(FBG≥11.1 mmol/L and/or RBG≥13.6 mmol/L）
• Patients with anemia(male:Hb≤120 g/L；female：Hb≤110 g/L)
• Patients complicated with systemic diseases included thyroid dysfunction、glaucoma、cataract，neurological、mental、psychological disease and any other disease that influence the judgment.
• Severe concurrent pathology, including terminal illness (cancer, AIDS, etc.).
• Patients with mental or legal disorder.
• Patients who were suspected addicted into alcohol or drug abuse or with severe complications that would make the condition more complicated assessed by the investigator.

Sponsors & Collaborators

• Xintong Pharmacy Company: lead

Study Sites (3)

Guizhou Provincial People's Hospital

Guiyang, Guizhou, 550001, China

RECRUITING

Zhongda Hospital Southeast University

Nanjing, Jiangsu, 210009, China

RECRUITING

The General Hospital of Shenyang Military

Shenyang, Liaoning, 110016, China

RECRUITING

MeSH Terms

Conditions

Angina Pectoris

Interventions

Ivabradine; Atenolol

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2015
• First Posted: December 7, 2015
• Study Start: October 1, 2014
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: December 7, 2015

Record last verified: 2015-12

Locations

CN (3)