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

General Hospital of Chinese Armed Police Forces

Status: Unknown

Conditions: Coronary Artery Disease

Treatments: Behavioral: Counseling and psychosocial support; Drug: Varenicline

Study type: Interventional

Funder types: Other

Identifiers

NCT01308671

PCTC-001-WS704502

Details and patient eligibility

About

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.

Full 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.

Enrollment: 198 estimated patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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198 participants in 2 patient groups

varenicline

Active Comparator group

Description:

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.

Treatment:

Drug: Varenicline

Behavioral: Counseling and psychosocial support

Blank

Other group

Description:

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

Treatment:

Behavioral: Counseling and psychosocial support