Influence of Varenicline on the Antiplatelet Action of Clopidogrel
VACL
1 other identifier
interventional
198
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable coronary-artery-disease
Started Oct 2010
Longer than P75 for not_applicable coronary-artery-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2010
CompletedFirst Submitted
Initial submission to the registry
January 28, 2011
CompletedFirst Posted
Study publicly available on registry
March 4, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2016
CompletedJune 24, 2015
April 1, 2015
5.2 years
January 28, 2011
June 23, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The platelet reactivity index (PRI) values in the two groups
To compare PRI values at the 14-day-treatment period between the 2 groups.
14 days
Secondary Outcomes (3)
Platelet aggregometry values in the two groups
7days,14 days
Urea nitrogen （BUN） and creatinine（Cr）values in the two groups
7days, 14 days
Number of patients with adverse events and serious adverse events as a measure of safety in the two groups
7 days,14 days
Study Arms (2)
varenicline
ACTIVE COMPARATOROn 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.
Blank
OTHERBlank group will be only administered with Counseling and psychosocial support,beside antiplatelet etc.conventional therapy for 14 days.
Interventions
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
Blank group will receive the same counseling and psychosocial support as varenicline group
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
General Hospital of Chinese People's Armed Police Forces
Beijing, 100039, China
Related Publications (11)
Puranik R, Celermajer DS. Smoking and endothelial function. Prog Cardiovasc Dis. 2003 May-Jun;45(6):443-58. doi: 10.1053/pcad.2003.YPCAD13.
PMID: 12800127RESULTSojka JE, Weiss JS, Samuels ML, You GM. Effect of the somatostatin analogue octreotide on gastric fluid pH in ponies. Am J Vet Res. 1992 Oct;53(10):1818-21.
PMID: 1456527RESULTMcGill HC Jr, McMahan CA, Malcom GT, Oalmann MC, Strong JP. Effects of serum lipoproteins and smoking on atherosclerosis in young men and women. The PDAY Research Group. Pathobiological Determinants of Atherosclerosis in Youth. Arterioscler Thromb Vasc Biol. 1997 Jan;17(1):95-106. doi: 10.1161/01.atv.17.1.95.
PMID: 9012643RESULTGalan KM, Deligonul U, Kern MJ, Chaitman BR, Vandormael MG. Increased frequency of restenosis in patients continuing to smoke cigarettes after percutaneous transluminal coronary angioplasty. Am J Cardiol. 1988 Feb 1;61(4):260-3. doi: 10.1016/0002-9149(88)90927-7.
PMID: 2963518RESULTCritchley JA, Capewell S. Mortality risk reduction associated with smoking cessation in patients with coronary heart disease: a systematic review. JAMA. 2003 Jul 2;290(1):86-97. doi: 10.1001/jama.290.1.86.
PMID: 12837716RESULTChobanian AV, Bakris GL, Black HR, Cushman WC, Green LA, Izzo JL Jr, Jones DW, Materson BJ, Oparil S, Wright JT Jr, Roccella EJ; National Heart, Lung, and Blood Institute Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure; National High Blood Pressure Education Program Coordinating Committee. The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure: the JNC 7 report. JAMA. 2003 May 21;289(19):2560-72. doi: 10.1001/jama.289.19.2560. Epub 2003 May 14.
PMID: 12748199RESULTObach RS, Reed-Hagen AE, Krueger SS, Obach BJ, O'Connell TN, Zandi KS, Miller S, Coe JW. Metabolism and disposition of varenicline, a selective alpha4beta2 acetylcholine receptor partial agonist, in vivo and in vitro. Drug Metab Dispos. 2006 Jan;34(1):121-30. doi: 10.1124/dmd.105.006767. Epub 2005 Oct 12.
PMID: 16221753RESULTBurstein AH, Clark DJ, O'Gorman M, Willavize SA, Brayman TG, Grover GS, Walsky RL, Obach RS, Faessel HM. Lack of pharmacokinetic and pharmacodynamic interactions between a smoking cessation therapy, varenicline, and warfarin: an in vivo and in vitro study. J Clin Pharmacol. 2007 Nov;47(11):1421-9. doi: 10.1177/0091270007307574.
PMID: 17962429RESULTBliden KP, Dichiara J, Lawal L, Singla A, Antonino MJ, Baker BA, Bailey WL, Tantry US, Gurbel PA. The association of cigarette smoking with enhanced platelet inhibition by clopidogrel. J Am Coll Cardiol. 2008 Aug 12;52(7):531-3. doi: 10.1016/j.jacc.2008.04.045.
PMID: 18687246RESULTSchwarz UR, Geiger J, Walter U, Eigenthaler M. Flow cytometry analysis of intracellular VASP phosphorylation for the assessment of activating and inhibitory signal transduction pathways in human platelets--definition and detection of ticlopidine/clopidogrel effects. Thromb Haemost. 1999 Sep;82(3):1145-52.
PMID: 10494779RESULTAleil B, Ravanat C, Cazenave JP, Rochoux G, Heitz A, Gachet C. Flow cytometric analysis of intraplatelet VASP phosphorylation for the detection of clopidogrel resistance in patients with ischemic cardiovascular diseases. J Thromb Haemost. 2005 Jan;3(1):85-92. doi: 10.1111/j.1538-7836.2004.01063.x.
PMID: 15634270RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hui Liang Liu, Doctor
Department of Cardiology of General Hospital of Chinese People's Armed Police Forces
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 28, 2011
First Posted
March 4, 2011
Study Start
October 1, 2010
Primary Completion
December 1, 2015
Study Completion
April 1, 2016
Last Updated
June 24, 2015
Record last verified: 2015-04