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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by General Hospital of Chinese Armed Police Forces.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
General Hospital of Chinese Armed Police Forces
ClinicalTrials.gov Identifier:
NCT01308671
First received: January 28, 2011
Last updated: June 26, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention
Coronary Artery Disease
Drug: Varenicline tartrate tablets
Behavioral: Counseling and psychosocial support

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Influence of Varenicline on the Antiplatelet Action of Clopidogrel : the Randomized, Open-label VACL (Varenicline Clopidogrel) Study

Resource links provided by NLM:


Further study details as provided by General Hospital of Chinese Armed Police Forces:

Primary Outcome Measures:
  • The platelet reactivity index (PRI) values in the two groups [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
    To compare PRI values at the 14-day-treatment period between the 2 groups.


Secondary Outcome Measures:
  • Platelet aggregometry values in the two groups [ Time Frame: 7days,14 days ] [ Designated as safety issue: Yes ]
    To compare platelet aggregometry values at the 7-day,14-day-treatment period between the 2 groups.

  • Urea nitrogen (BUN) and creatinine(Cr)values in the two groups [ Time Frame: 7days, 14 days ] [ Designated as safety issue: Yes ]
    To compare BUN and Cr values at the 7-day,14-day-treatment period between the 2 groups.

  • 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 ] [ Designated as safety issue: Yes ]
    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


Estimated Enrollment: 198
Study Start Date: October 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: varenicline
All patients receive aspirin and clopidogrel,after three days they will be randomly divided into two groups.Varenicline group will be administered with varenicline besides antiplatelet etc. conventional therapy for 14 days.
Drug: Varenicline tartrate tablets
0.5 mg/d for days 1 to 3, 0.5 mg twice per day for days 4 to 7, then 1 mg twice per day for 14 days
Other Name: Champix
Behavioral: Counseling and psychosocial support
Blank group will receive the same counseling and psychosocial support as varenicline group
Other Name: nonpharmacologic therapy
Blank
Blank group will be only administered with 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 Name: nonpharmacologic therapy

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.

  Eligibility

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01308671

Contacts
Contact: Hui Liang Liu, Doctor 86-10-88276531 lhl518@vip.sina.com
Contact: Yu Jie Wei, Master 86-10-88276707 weiyujie6980@sina.com

Locations
China
General Hospital of Chinese People's Armed Police Forces Recruiting
Beijing, China, 100039
Contact: Hui Liang Liu, Doctor    86-01-88276531    lhl518@vip.sina.com   
Contact: Yu Jie Wei, Master    86-01-88276707    weiyujie6980@sina.com   
Principal Investigator: Hui Liang Liu, Doctor         
Principal Investigator: Yu Jie Wei, Master         
Sub-Investigator: Jie Sun, Master         
Sponsors and Collaborators
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
  More Information

Publications:

Responsible Party: General Hospital of Chinese Armed Police Forces
ClinicalTrials.gov Identifier: NCT01308671     History of Changes
Other Study ID Numbers: PCTC-001-WS704502
Study First Received: January 28, 2011
Last Updated: June 26, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by General Hospital of Chinese Armed Police Forces:
coronary artery disease
varenicline
clopidogrel

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases
Clopidogrel
Varenicline
Cholinergic Agents
Cholinergic Agonists
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Nicotinic Agonists
Pharmacologic Actions
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Purinergic Agents
Purinergic Antagonists
Purinergic P2 Receptor Antagonists
Purinergic P2Y Receptor Antagonists
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014