Efficacy of Varenicline Tartrate in Treating Frequent Premature Ventricular Contractions

NCT06780215 | Completed Phase 2 DMC

• 2 other identifiers: 2025YS-002NCT06780215
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief Summary

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:

1. 1.The responder rate for PVCs at Weeks 4, 6, and 8. 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.
2. 2.The incidence of NSVT from randomization through Weeks 4, 6, and 8.
3. 3.The change from baseline in the 24-hour mean count and burden of PVCs at Weeks 4, 6, and 8.
4. 4.The change from baseline in the 24-hour mean episodes and burden of non-sustained ventricular tachycardia (NSVT) at Weeks 4, 6, and 8.
5. 5.The change from baseline in the Kansas City Cardiomyopathy Questionnaire (KCCQ) score at Week 6.
6. 6.Continuous (quantitative) variables: Summarized with n, mean, standard deviation, median, interquartile range, minimum, and maximum.
7. 7.Categorical (count) variables: Presented as n (%). Unless otherwise specified, percentages will be calculated using the number of participants in the relevant analysis population as the denominator.

Conditions

Premature Ventricular Contraction (PVC)

Keywords

Premature ventricular contractions; Varenicline; Myocardial infarction

Outcome Measures

Primary Outcomes (1)

• Percentage reduction in the average 24-hour count of premature ventricular contractions

  Week 6

Secondary Outcomes (5)

• The responder rate for premature ventricular contractions (PVCs) .

  At Weeks 4, 6, and 8.

• The incidence of non-sustained ventricular tachycardia (NSVT).

  At Weeks 4, 6, and 8.

• Changes from baseline in the average 24-hour count and burden of premature ventricular contractions

  Weeks 4, 6, and 8

• Changes from baseline in the average 24-hour number of episodes and burden of non-sustained ventricular tachycardia

  Weeks 4, 6, and 8

• Change from baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) score

  Week 6

Other Outcomes (1)

• 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).

  From randomization through Weeks 4, 6, and 8.

Study Arms (2)

Control Group

PLACEBO COMPARATOR

Participants receive placebo tablets according to the treatment group design.

Drug: Placebo

Treatment Group

EXPERIMENTAL

Participants take varenicline tartrate tablets according to the regimen

Drug: Varenicline Tartrate Tablets

Interventions

Varenicline Tartrate Tablets DRUG

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.

Treatment Group

Placebo DRUG

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.

Control Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged between 18 and 80 years old (inclusive).
• Premature ventricular contractions of ≥1000 times/average 24-hour revealed by screening (72-hour Holter monitoring).
• Definite diagnosis of myocardial infarction for more than 4 weeks, with NYHA Class I-II.
• Maintained on Metoprolol Succinate Sustained-release Tablets. (If other types of beta-blocker therapy were being used before screening, they must be replaced with Metoprolol Succinate Sustained-release Tablets.)
• Understand and comply with the study procedures and methods, and sign the informed consent form.

You may not qualify if:

• Myocardial infarction occurring within 4 weeks.
• NYHA Class III-IV.
• Use of amiodarone within 1 month before screening.
• Use of antiarrhythmic drugs, or traditional Chinese medicine, Chinese patent medicine for arrhythmia other than amiodarone within 1 week prior to screening.
• Sustained ventricular tachycardia, ventricular flutter, or ventricular fibrillation detected during screening (non-sustained ventricular tachycardia does not need to be excluded).
• Sick sinus syndrome without pacemaker implantation, II-III degree atrioventricular block, or bundle branch block bilateral.
• Moderate to severe bronchial asthma or severe chronic obstructive pulmonary disease.
• Severe renal impairment (eGFR less than 30 mL/min/1.73 m²).
• Hyperthyroidism.
• Severe sequelae of stroke.
• Epilepsy, schizophrenia, or depression.
• Pregnant or breastfeeding women, or those with a positive blood pregnancy test result before randomization.
• Combined cancer or other diseases, with an expected life expectancy of less than 1 year.
• Perioperative period of cardiothoracic surgery (1 week before surgery to 2 weeks after surgery).
• Severe electrolyte disturbance.

Sponsors & Collaborators

• Yihan Chen: lead

Study Sites (1)

Shanghai East Hospital

Shanghai, Shanghai Municipality, 200120, China

Location

MeSH Terms

Conditions

Ventricular Premature Complexes; Myocardial Infarction

Interventions

Varenicline

Condition Hierarchy (Ancestors)

Cardiac Complexes, Premature; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Myocardial Ischemia; Vascular Diseases; Infarction; Ischemia; Necrosis

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines

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 INVESTIGATOR
• PI Title: President, Shanghai East Hospital

Model Details: This is an investigator-initiated, multicenter, randomized, double-blind, parallel-group，placebo-controlled superiority trial.

Study Record Dates

• First Submitted: January 13, 2025
• First Posted: January 17, 2025
• Study Start: February 17, 2025
• Primary Completion: September 1, 2025
• Study Completion: September 14, 2025
• Last Updated: November 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)