Influence of Varenicline on the Antiplatelet Action of Clopidogrel (VACL)

June 23, 2015 updated by: General Hospital of Chinese Armed Police Forces

Influence of Varenicline on the Antiplatelet Action of Clopidogrel : the Randomized, Open-label VACL (Varenicline Clopidogrel) Study

The purpose of this study is to investigate the effects of steady-state varenicline on the antiplatelet action of clopidogrel in patients with coronary artery disease.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Smoking is a major risk factor for cardiovascular disease (CVD). Compared with nonsmokers, smokers are approximately twice as likely to develop CVD, and three times more likely to die from it. This increased risk is due to the deleterious effects of smoking on endothelial function and blood coagulation, and the development of coronary atherosclerotic plaques. A research showed that continued smoking after successful percutaneous coronary intervention(PCI) is associated with an increased risk of restenosis. However, smoking cessation can make a 36% reduction in crude relative risk (RR) of mortality for patients with CVD. Hence current management guidelines now advocate smoking cessation, in addition to controlling hypertension and dyslipidemia, as part of an overall cardiovascular risk reduction strategy. Varenicline is a novel selective nicotinic acetylcholine receptor partial agonist that has been approved in over 70 countries worldwide as an aid to smoking cessation. Clopidogrel is widely used by patients with coronary artery disease undergoing PCI. The relationship between smoking and cardiovascular disease increases the prospect of patients receiving smoking cessation therapy and Clopidogrel concomitantly in clinical practice. Plasma protein binding of Varenicline is low(≤20%) and independent of age or renal function. The major route of clearance for varenicline is renal excretion. Clopidogrel, a prodrug, is metabolized by 2 consecutive cytochrome P450-dependent steps to its active metabolite, which binds irreversibly to the platelet P2Y12 receptor. The likelihood of a clinically relevant drug-drug interaction between varenicline and Clopidogrel was considered to be low; nevertheless, the possibility of an interaction between these 2 drugs is lack of clinical evidences. Hence, our hypothesis is that varenicline may have no influence on the antiplatelet action of clopidogrel.

Study Type

Interventional

Enrollment (Anticipated)

198

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100039
        • Recruiting
        • General Hospital of Chinese People's Armed Police Forces
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hui Liang Liu, Doctor
        • Principal Investigator:
          • Yu Jie Wei, Master
        • Sub-Investigator:
          • Jie Sun, Master

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients with coronary artery disease(CAD) undergoing PCI in hospital
  • smoke 10 or more cigarettes per day
  • fewer than 3 months of smoking abstinence in the past year
  • motivation to stop smoking

Exclusion Criteria:

  • history of previous treatment with clopidogrel or varenicline
  • thrombocytopenia(<150,000 platelets/ml)
  • bleeding disorder
  • liver disease
  • gastrointestinal ulcer
  • pregnancy
  • cancer
  • clinically significant allergic reactions
  • mental disorders
  • drug or alcohol abuse

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: varenicline
On 3 day after received clopidogrel 75mg/day, Varenicline group will be administered with varenicline 0.5mg Qd,after 3 days, 0.5mg Bid,after 7days,1mg Bid .And received counseling and psychosocial support.
Drug: Varenicline
Varenicline will be administrated 0.5 mg Qd for 3 days,0.5 mg Bid for 4 days, and then 1 mg Bid for 14 days
Other Names:
  • Champix
Behavioral: Counseling and psychosocial support
Blank group will receive the same counseling and psychosocial support as varenicline group
Other Names:
  • nonpharmacologic therapy
Other: Blank
Blank group will be only administered with Counseling and psychosocial support,beside antiplatelet etc.conventional therapy for 14 days.
Behavioral: Counseling and psychosocial support
Blank group will receive the same counseling and psychosocial support as varenicline group
Other Names:
  • nonpharmacologic therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The platelet reactivity index (PRI) values in the two groups
Time Frame: 14 days
To compare PRI values at the 14-day-treatment period between the 2 groups.
14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Platelet aggregometry values in the two groups
Time Frame: 7days,14 days
To compare platelet aggregometry values at the 7-day,14-day-treatment period between the 2 groups.
7days,14 days
Urea nitrogen （BUN） and creatinine（Cr）values in the two groups
Time Frame: 7days, 14 days
To compare BUN and Cr values at the 7-day,14-day-treatment period between the 2 groups.
7days, 14 days
Number of patients with adverse events and serious adverse events as a measure of safety in the two groups
Time Frame: 7 days,14 days
To compare the number of patients with adverse events and serious adverse events at the 7-day,14-day-treatment period between the 2 groups
7 days,14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

General Hospital of Chinese Armed Police Forces

Investigators

  • Principal Investigator: Hui Liang Liu, Doctor, Department of Cardiology of General Hospital of Chinese People's Armed Police Forces

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

April 1, 2016

Study Registration Dates

First Submitted

January 28, 2011

First Submitted That Met QC Criteria

March 2, 2011

First Posted (Estimate)

March 4, 2011

Study Record Updates

Last Update Posted (Estimate)

June 24, 2015

Last Update Submitted That Met QC Criteria

June 23, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PCTC-001-WS704502

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Coronary Artery Disease

Clinical Trials on Varenicline

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Trinidad & Tobago

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe