Coronary Artery DiseaseVACLNCT01308671
Influence of Varenicline on the Antiplatelet Action of Clopidogrel
A study testing Varenicline and Counseling and psychosocial support in people with Coronary Artery Disease, run by General Hospital of Chinese Armed Police Forces at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Varenicline and Counseling and psychosocial support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 1 siteChina
- Study dates
- Oct 2010to Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- history of previous treatment with clopidogrel or varenicline
- thrombocytopenia(<150,000 platelets/ml)
- bleeding disorder
- liver disease
- gastrointestinal ulcer
- pregnancy
Show all 10Show fewer
- cancer
- clinically significant allergic reactions
- mental disorders
- drug or alcohol abuse
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
General Hospital of Chinese People's Armed Police Forces
Beijing, 100039
Hui Liang Liu, Doctor, 86-01-88276531, lhl518@vip.sina.com
Yu Jie Wei, Master, 86-01-88276707, weiyujie6980@sina.com
About this study
Official title: 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.
Read the 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
- Being tested
- Varenicline, Counseling and psychosocial support
- Keywords
- coronary artery disease, varenicline, clopidogrel
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VareniclineDrug
Also called Champix
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 supportBehavioural
Also called nonpharmacologic therapy
Blank group will receive the same counseling and psychosocial support as varenicline group
| Study group | Role | What they receive |
|---|---|---|
| varenicline | Active comparator | 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. Receives: Drug: Varenicline; Behavioral: Counseling and psychosocial support |
| Blank | Other | Blank group will be only administered with Counseling and psychosocial support,beside antiplatelet etc.conventional therapy for 14 days. Receives: Behavioral: Counseling and psychosocial support |
What is being measured
The primary outcome is the main question the study is designed to answer.
The platelet reactivity index (PRI) values in the two groups
To compare PRI values at the 14-day-treatment period between the 2 groups.
Measured: 14 days
Secondary outcomes (3)
Platelet aggregometry values in the two groups
To compare platelet aggregometry values at the 7-day,14-day-treatment period between the 2 groups.
Measured: 7days,14 days
Urea nitrogen （BUN） and creatinine（Cr）values in the two groups
To compare BUN and Cr values at the 7-day,14-day-treatment period between the 2 groups.
Measured: 7days, 14 days
Number of patients with adverse events and serious adverse events as a measure of safety in the two groups
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
Measured: 7 days,14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2011 (estimated)
- Study startOct 2010
- Primary completionDec 2015 (estimated)
- Study completionApr 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 198 participants (estimated)
Sponsor and investigators
- Lead sponsor
- General Hospital of Chinese Armed Police Forces
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hui Liang Liu, Doctor, Principal investigator, Department of Cardiology of General Hospital of Chinese People's Armed Police Forces
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01308671
- Sponsor's protocol ID
- PCTC-001-WS704502
- Acronym
- VACL
- Status last verified
- Apr 2015
- First submitted
- 28 Jan 2011
- Last updated
- 24 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Puranik R, Celermajer DS. Smoking and endothelial function. Prog Cardiovasc Dis. 2003 May-Jun;45(6):443-58. doi: 10.1053/pcad.2003.YPCAD13.
PubMed 12800127Sojka 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.
PubMed 1456527McGill 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.
PubMed 9012643Galan 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.
PubMed 2963518Critchley 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.
PubMed 12837716Chobanian 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.
PubMed 12748199Obach 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.
PubMed 16221753Burstein 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.
PubMed 17962429Bliden 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.
PubMed 18687246Schwarz 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.
PubMed 10494779Aleil 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.
PubMed 15634270
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Varenicline on the Antiplatelet Action of Clopidogrel : the Randomized, Open-label VACL (Varenicline Clopidogrel) Study
- ClinicalTrials.gov ID
- NCT01308671
- Acronym / sponsor ID
- VACL / PCTC-001-WS704502
- Conditions
- Coronary Artery Disease
- Keywords
- coronary artery disease, varenicline, clopidogrel
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 198 participants (estimated)
- Lead sponsor
- General Hospital of Chinese Armed Police ForcesUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Apr 2016 (estimated)
- First posted
- 4 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| varenicline | Active comparator | Drug: Varenicline, Behavioral: Counseling and psychosocial supportOn 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 | Other | Behavioral: Counseling and psychosocial supportBlank group will be only administered with Counseling and psychosocial support,beside antiplatelet etc.conventional therapy for 14 days. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- history of previous treatment with clopidogrel or varenicline
- thrombocytopenia(<150,000 platelets/ml)
- bleeding disorder
- liver disease
- gastrointestinal ulcer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VareniclineAlso: ChampixVarenicline 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 | Drug | varenicline |
| Counseling and psychosocial supportAlso: nonpharmacologic therapyBlank group will receive the same counseling and psychosocial support as varenicline group | Behavioural | Blank, varenicline |
Primary outcome
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.
3 secondary outcomes
Platelet aggregometry values in the two groups
Time frame: 7days,14 days
Urea nitrogen （BUN） and creatinine（Cr）values in the two groups
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2015.
- Results publication: PubMed 12800127Puranik R, Celermajer DS. Smoking and endothelial function. Prog Cardiovasc Dis. 2003 May-Jun;45(6):443-58. doi: 10.1053/pcad.2003.YPCAD13.
- Results publication: PubMed 1456527Sojka 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.
- Results publication: PubMed 9012643McGill 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.
- Results publication: PubMed 2963518Galan 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.
- Results publication: PubMed 12837716Critchley 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.
- Results publication: PubMed 12748199Chobanian 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.
- Results publication: PubMed 16221753Obach 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.
- Results publication: PubMed 17962429Burstein 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.
- Results publication: PubMed 18687246Bliden 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.
- Results publication: PubMed 10494779Schwarz 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.
- Results publication: PubMed 15634270Aleil 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hui Liang Liu, Doctor principal investigator
Department of Cardiology of General Hospital of Chinese People's Armed Police Forces
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Varenicline and Counseling and psychosocial support in people with Coronary Artery Disease, run by General Hospital of Chinese Armed Police Forces at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hui Liang Liu, Doctor (86-10-88276531, lhl518@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The platelet reactivity index (PRI) values in the two groups (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01308671, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2015.