Angina PectorisPhase 2NCT02623569
To Assess the Anti-anginal Safety and Efficacy of Ivabradine in Subjects With Stable，Symptomatic Chronic Angina
A Phase 2 study testing Ivabradine and Atenolol in people with Angina Pectoris, run by Xintong Pharmacy Company at 3 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Angina Pectoris
- What is being tested?
- Ivabradine and Atenolol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 336 participants
- Where
- 3 sitesChina
- Study dates
- Oct 2014to Jun 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
- People have liver or renal dysfunction (ALT≥2×ULN、AST≥2×ULN、eGFR≤60ml/min/1.73m2）
- Patients who should use unapproved drug during the study.
- Patients who accepted amiodarone(in recent 3 months)and/or benzetimide、βblockers（in recent 7 days)、
- Patients with history of allergy or suspected allergic to the drug（e.g.，Hydrochloric ivabradine,atenolol, βblockers）or lactose.
- Woman who disagree with contraception during treatment period ，with pregnancy, lactation or positive result of pregnancy test.
- Patients with Chronic Obstructive Pulmonary Disease (COPD) requiring bronchodilators.
- Patients who is participating in other trials or has been participated in other trials in recent 3 months
- Patients who were unable to participate in the study as judged by investigator.
Trial locations and contacts
3 sites in 1 country.
China3 sites, 3 recruiting
- Recruiting
Guizhou Provincial People's Hospital
Guiyang, Guizhou, 550001
Ping Zhang, 0851-5623033, xin7110p@163.com
- Recruiting
Zhongda Hospital Southeast University
Nanjing, Jiangsu, 210009
Genshan Ma, 025-83272038, Magenshan@hotmail.com
- Recruiting
The General Hospital of Shenyang Military
Shenyang, Liaoning, 110016
Yaling Han, 024-28897309, hanyaling@263.net
About this study
Official title: Evaluation of the Anti-anginal Efficacy and Safety of Ivabradine Used in Patients With Stable Effort Angina Pectoris. A 12 Weeks Randomised, Double-blind Controlled, Parallel-group, Multicentre Study
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.
Read the detailed description
- Washout period：Chronic angina patients stop using medicine that affect heart rate. The patients undergoes ETT after 2-7 days and positive ETT into the treatment period(If not take similar medicine, patients can be carried out ETT directly)。
- Treatment period：Patients carried out ETT after therapy with Ivabradine(5mg,bid)/ Atenolol(12.5mg,bid) for 4 weeks.The dose adjust base on test result and heart rate, Ivabradine(5mg,bid)/Atenolol(12.5mg,bid) or Ivabradine(7.5mg,bid)/ Atenolol(25mg,bid) for 8 weeks and carried out ETT.
- security period：After the treatment period, all patients to take Atenolol 12.5mg/ 25mg bid 1 week.
If heart rate are low 50 times/min after taking Ivabradine 5mg/ Atenolol 12.5mg, subjects should withdrawal and dropped out study. If subjects heart rate are low 50 times/min after taking Ivabradine 7.5mg/ Atenolol 25mg, subjects should change the dose to Ivabradine 5mg/ Atenolol 12.5mg.
- Conditions
- Angina Pectoris
- Being tested
- Ivabradine, Atenolol
- Medical subject headings
- Angina Pectoris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IvabradineDrug
Also called Not Provided
Not Provided
AtenololDrug
Also called Not Provided
Not Provided
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Atenolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy endpoint is Change from total exercise duration in exercise tolerance test (ETT)
Measured: Baseline and end of treatment (Week 12) .
Secondary outcomes (4)
Time to angina in exercise tolerance test.
Measured: 12 weeks
Time to 1 mm ST-segment depression in exercise tolerance test
Measured: 12 weeks
Number of angina attacks in exercise tolerance test per week
Measured: 12 weeks
Number of sublingual nitroglycerin consumption per week
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2015 (estimated)
- Study startOct 2014
- Primary completionJun 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Angina PectorisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 336 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xintong Pharmacy Company
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02623569
- Sponsor's protocol ID
- A130901CSPF01
- Status last verified
- Dec 2015
- First submitted
- 29 Nov 2015
- Last updated
- 7 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Anti-anginal Efficacy and Safety of Ivabradine Used in Patients With Stable Effort Angina Pectoris. A 12 Weeks Randomised, Double-blind Controlled, Parallel-group, Multicentre Study
- ClinicalTrials.gov ID
- NCT02623569
- Acronym / sponsor ID
- A130901CSPF01
- Conditions
- Angina Pectoris
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 336 participants (estimated)
- Lead sponsor
- Xintong Pharmacy CompanyUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 7 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- Washout period：Chronic angina patients stop using medicine that affect heart rate. The patients undergoes ETT after 2-7 days and positive ETT into the treatment period(If not take similar medicine, patients can be carried out ETT directly)。
- Treatment period：Patients carried out ETT after therapy with Ivabradine(5mg,bid)/ Atenolol(12.5mg,bid) for 4 weeks.The dose adjust base on test result and heart rate, Ivabradine(5mg,bid)/Atenolol(12.5mg,bid) or Ivabradine(7.5mg,bid)/ Atenolol(25mg,bid) for 8 weeks and carried out ETT.
- security period：After the treatment period, all patients to take Atenolol 12.5mg/ 25mg bid 1 week.
If heart rate are low 50 times/min after taking Ivabradine 5mg/ Atenolol 12.5mg, subjects should withdrawal and dropped out study. If subjects heart rate are low 50 times/min after taking Ivabradine 7.5mg/ Atenolol 25mg, subjects should change the dose to Ivabradine 5mg/ Atenolol 12.5mg.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ivabradine | Experimental | Drug: IvabradineIvabradine 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. |
| Atenolol | Active comparator | Drug: AtenololAtenolol 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
- ultrasonic cardiogram disclosed that left ventricular ejection fraction ≥50 %.
Key exclusion criteria (23 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IvabradineAlso: Not ProvidedNot Provided | Drug | Ivabradine |
| AtenololAlso: Not ProvidedNot Provided | Drug | Atenolol |
Primary outcome
The primary efficacy endpoint is Change from total exercise duration in exercise tolerance test (ETT)
Time frame: Baseline and end of treatment (Week 12) .
4 secondary outcomes
Time to angina in exercise tolerance test.
Time frame: 12 weeks
Time to 1 mm ST-segment depression in exercise tolerance test
Time frame: 12 weeks
Number of angina attacks in exercise tolerance test per week
Time frame: 12 weeks
Number of sublingual nitroglycerin consumption per week
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ivabradine and Atenolol in people with Angina Pectoris, run by Xintong Pharmacy Company at 3 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary efficacy endpoint is Change from total exercise duration in exercise tolerance test (ETT) (time frame: Baseline and end of treatment (Week 12) .). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2015.