A Phase 2 interventional study of Varenicline Tartrate Tablets and Placebo in Premature Ventricular Contraction (PVC), sponsored by Yihan Chen. Completed at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-11-19.
Sponsored by Yihan Chen · Phase 2, Interventional, and Treatment
This is an investigator-initiated, multicenter, randomized, double-blind, placebo-controlled, parallel-group clinical trial designed to evaluate the preliminary efficacy of varenicline tartrate in patients with frequent PVCs complicated by myocardial infarction (MI). The protocol was approved by the institutional review board and ethics committee at each participating center.
Primary Efficacy Endpoint:
1) The percentage change from baseline in the 24-hour mean count of PVCs at Week 6.
Secondary Efficacy Endpoints:
Pre-specified Safety Endpoints:
Primary Endpoint: The cumulative incidence of the first occurrence of malignant ventricular arrhythmias (time-to-first event), including sustained ventricular tachycardia (SVT), ventricular fibrillation (VF), or ventricular flutter (VFL), from randomization through Weeks 4, 6, and 8.
Study Population:
A total of 116 participants, aged 18-80 years, with frequent PVCs wil be enrolled. Prior to enrollment, participants must have stable cardiac conditions and must have received standard treatment for acute or chronic coronary syndrome as recommended by the relevant guidelines, including sustained-release metoprolol succinate. Following preliminary screening, participants will undergo 72-hour continuous three-lead AECG monitoring (baseline data) to assess the baseline PVC frequency. Eligibility for inclusion will be determined based on the monitoring data. Eligible participants will then be randomized in a 1:1 ratio (Day 0) to either the treatment group (varenicline tartrate tablets) or the placebo group.
Treatment Protocol:
All participants will receive sustained-release metoprolol succinate as part of the standard treatment, in accordance with clinical guidelines. The dose will remain stable throughout the study, unless adjustments are required for patient safety. Other standard treatments recommended by the guidelines, aside from sustained-release metoprolol succinate, will be optimized according to the clinical guidelines throughout the study.
Randomization and Stratification:
A total of 116 participants will be enrolled and randomized to either the treatment or placebo group, with 58 participants in each group. Stratification will be based on left ventricular ejection fraction (LVEF ≥ 50% vs. LVEF \< 50%).
Treatment Regimen:
Treatment Group (Varenicline Tartrate 0.5 mg/tablet): Participants will receive the following regimen:
Days 1-3: 0.5 mg once daily. Days 4-42: 0.5 mg twice daily, taken at the same times each day (recommended interval 12 hours ± 2 hours).
Days 43-45: 0.5 mg once daily.
Placebo Group: Participants will receive placebo tablets according to the same regimen as the treatment group:
Days 1-3: 1 tablet once daily. Days 4-42: 1 tablet twice daily, taken at the same times each day (recommended interval 12 hours ± 2 hours).
Days 43-45: 1 tablet once daily. Statistical Analysis General Principles
Efficacy Analysis
1） Primary endpoint: The between-group difference will be assessed by estimating the mean difference in the percentage reduction from baseline in the 24-hour mean PVC count at Week 6, with 95% confidence intervals (CIs).
Secondary endpoints: Two key secondary efficacy end points will be formally tested using a fixed-sequence (hierarchical) procedure.
Key Secondary End Point 1: The responder rate for PVCs at Week 6. Key Secondary End Point 2: The incidence of NSVT at Week 6. All other secondary efficacy endpoints will be summarized descriptively. Safety Analysis The cumulative incidence of malignant ventricular arrhythmias will be estimated using Kaplan-Meier survival curves, with differences between groups compared using the Cox proportional hazards model (reporting the hazard ratio [HR] and 95% CI). If no events occur in either group or if the number of events is too low, only the number of events and their percentages will be reported.
102 studies on the registry are indexed under Ventricular Premature Complexes; 32 are open to participants now.
This study's enrollment of 116 is above the median of 84 across 58 interventional studies indexed under Ventricular Premature Complexes.
Browse Ventricular Premature Complexes studies →This is the only study on the registry with Yihan Chen as lead sponsor.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive placebo tablets according to the treatment group design.
Drug: Placebo
Participants take varenicline tartrate tablets according to the regimen
Drug: Varenicline Tartrate Tablets
Participants in treatment group take varenicline tartrate tablets according to the following regimen: Days 1-3: 0.5 mg/dose, once daily. Days 4-42: 0.5 mg/dose, twice daily, taken orally at the same time each morning and evening (the dosing interval is recommended to be 12 h ± 2 h). Days 43-45: 0.5 mg/dose, once daily.
Days 1-3: 1 tablet/dose, once daily. Days 4-42: 1 tablet/dose, twice daily, taken orally at the same time each morning and evening (the dosing interval is recommended to be 12 h ± 2 h). Days 43-45: 1 tablet/dose, once daily.
Percentage reduction in the average 24-hour count of premature ventricular contractions
Time frame: Week 6
The responder rate for premature ventricular contractions (PVCs) .
PVC responder: A participant is considered a responder if there is a ≥ 50% reduction from baseline in the 24-hour mean PVC count following treatment with either varenicline or placebo.
Time frame: At Weeks 4, 6, and 8.
The incidence of non-sustained ventricular tachycardia (NSVT).
If the 72-hour ECG monitoring shows a non-zero value for the number of NSVT episodes, it will be considered as "occurrence." If the number is zero, it will be considered as "non-occurrence." The incidence of NSVT at Weeks 4, 6, and 8 will be calculated by dividing the number of participants with NSVT episodes recorded by the 72-hour AECG monitoring by the total number of participants in each group, and then multiplying by 100%.
Time frame: At Weeks 4, 6, and 8.
Changes from baseline in the average 24-hour count and burden of premature ventricular contractions
Time frame: Weeks 4, 6, and 8
Changes from baseline in the average 24-hour number of episodes and burden of non-sustained ventricular tachycardia
Time frame: Weeks 4, 6, and 8
Change from baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) score
The KCCQ score ranges from 0 to 100, with higher scores indicating better outcomes.
Time frame: Week 6
Safety End Points: The cumulative incidence of the first occurrence of malignant ventricular arrhythmias (time-to-first event) , including sustained ventricular tachycardia (SVT), ventricular fibrillation (VF), or ventricular flutter (VFL).
The malignant ventricular arrhythmia events will be adjudicated by the Central Adjudication Committee (CEC) based on planned 72-hour continuous ambulatory electrocardiography (AECG) monitoring and unplanned clinical evidence, including emergency or inpatient 12-lead ECG, bedside monitoring or telemetry ECG, implantable cardioverter defibrillator (ICD) records, or cardiopulmonary resuscitation (CPR) records, using a standardized approach. An event will be counted if any of these criteria are met; each participant will be counted for a maximum of one event. The event time will be taken as the earliest verifiable evidence. The analysis will be based on the risk set starting from randomization.
Time frame: From randomization through Weeks 4, 6, and 8.
Plan to share: No
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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