Influence of Varenicline on the Antiplatelet Action of Clopidogrel

NCT ID: NCT01308671

Last Updated: 2015-06-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 198 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2016-04-30

Brief Summary

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.

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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Varenicline

Intervention Type: DRUG

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

Counseling and psychosocial support

Intervention Type: BEHAVIORAL

Blank group will receive the same counseling and psychosocial support as varenicline group

Blank

Blank group will be only administered with Counseling and psychosocial support,beside antiplatelet etc.conventional therapy for 14 days.

Group Type: OTHER

Counseling and psychosocial support

Intervention Type: BEHAVIORAL

Blank group will receive the same counseling and psychosocial support as varenicline group

Interventions

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

Intervention Type: DRUG

Counseling and psychosocial support

Blank group will receive the same counseling and psychosocial support as varenicline group

Intervention Type: BEHAVIORAL

Other Intervention Names

Champix; nonpharmacologic therapy

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

General Hospital of Chinese Armed Police Forces

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hui Liang Liu, Doctor

Role: PRINCIPAL_INVESTIGATOR

Department of Cardiology of General Hospital of Chinese People's Armed Police Forces

Locations

General Hospital of Chinese People's Armed Police Forces

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Hui Liang Liu, Doctor

Role: CONTACT

lhl518@vip.sina.com

86-10-88276531

Yu Jie Wei, Master

Role: CONTACT

weiyujie6980@sina.com

86-10-88276707

Facility Contacts

Hui Liang Liu, Doctor

Role: primary

lhl518@vip.sina.com

86-01-88276531

Yu Jie Wei, Master

Role: backup

weiyujie6980@sina.com

86-01-88276707

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Other Identifiers

PCTC-001-WS704502

Identifier Type: -

Identifier Source: org_study_id