- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01559298
Aspirin Versus Aspirin + ClopidogRel Following Transcatheter Aortic Valve Implantation: the ARTE Trial (ARTE)
May 10, 2017 updated by: Josep Rodes-Cabau, Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Aspirin Versus Aspirin + ClopidogRel as Antithrombotic Treatment Following Transcatheter Aortic Valve Implantation With the Edwards SAPIEN XT Valve. A Randomized Pilot Study (the ARTE Trial)
The purpose of this study is to compare aspirin + clopidogrel with aspirin alone as antithrombotic treatment following transcatheter aortic valve implantation (TAVI) for the prevention of major ischemic events [myocardial infarction (MI), ischemic stroke] or death without increasing the risk of major bleeding events.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Transcatheter aortic valve implantation (TAVI) has emerged as an alternative to standard aortic valve replacement for the treatment of patients considered to be at very high or prohibitive surgical risk.
Nowadays the procedure is associated with a very high success rate (> 95%) but major peri-procedural ischemic complications such as myocardial infarction (MI) or ischemic stroke occur in about 2% (0% to 17%) and 3% (2% to 7%) of the cases, respectively.
The recently published PARTNER trial showed a stroke rate as high as 6.5% within the 30 days following TAVI, with most (77%) of these events diagnosed as major strokes.
In order to avoid such ischemic complications full dose anticoagulation (usually intravenous heparin) is administered during the TAVI procedure, whereas aspirin (long-term) + clopidogrel (1 to 6 months) have been the recommended antithrombotic treatment following the procedure.
However, this antithrombotic regime has been recommended on an empirical basis, and no studies have as yet shown the efficacy of aspirin + clopidogrel versus aspirin alone or no antithrombotic treatment in preventing ischemic events following TAVI procedures.
Also, patients undergoing TAVI nowadays are usually octogenarians and very frequently exhibit comorbidities such as hypertension, abnormal renal function or prior cerebrovascular disease, which significantly increase the risk of major bleeding.
Indeed, TAVI procedures can also be associated with major vascular complications which in turn can complicate with life-threatening or major bleeding.
It is well know that clopidogrel on top of aspirin is associated with a higher rate of major bleeding complications, especially in elderly patients.
It would therefore be of major clinical relevance to determine the risk/benefit ratio of using a dual antithrombotic therapy following TAVI procedures in order to recommend the most appropriate antithrombotic treatment in this high-risk population.
The ARTE trial is a multicenter Canadian pilot trial to evaluate the efficacy and safety of aspirin versus aspirin + clopidogrel as antithrombotic treatment after TAVI.
Study Type
Interventional
Enrollment (Actual)
178
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Quebec, Canada, G1V 4G5
- IUCPQ
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British Columbia
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Vancouver, British Columbia, Canada, V6Z 1Y6
- St-Paul's Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients undergoing a TAVI procedure with the Edwards SAPIEN XT valve (transfemoral or transapical)
Exclusion Criteria:
- Need for chronic anticoagulation treatment
- Major bleeding within the 3 months prior to the TAVI procedure
- Prior intracranial bleeding
- Drug-eluting stent implantation within the year prior to the TAVI procedure
- Allergy to clopidogrel and/or aspirin
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Aspirin + clopidogrel
Patients will be randomized within the month prior to the TAVI procedure to receive aspirin (80 mg/d) + clopidogrel (75 mg/d) following the TAVI procedure.
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Aspirin (80 mg/d) + clopidogrel (75 mg/d) Aspirin therapy will start at least 24 hrs before the TAVI procedure and continued for at least 6 months.
Clopidogrel therapy will start within 24 hrs before the TAVI procedure in cases where a transfemoral approach is used and within 24 hrs after the TAVI procedure in cases where a transapical approach is used.
The initial dose of clopidogrel will be of 300 mg followed by 75 mg/die.
The duration of clopidogrel treatment will be of 3 months.
Patients will be followed either by phone contact or clinical visits at 1- and 12-month follow-up.
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ACTIVE_COMPARATOR: Aspirin
Patients will be randomized within the month prior to the TAVI procedure to receive aspirin (80 mg/d)
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Aspirin (80 mg/d) Aspirin therapy will start at least 24 hrs before the TAVI procedure and continued for at least 6 months.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of death, MI, ischemic stroke/Transient ischemic attack (TIA) or life threatening/major bleeding
Time Frame: 12-month follow-up
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12-month follow-up
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence of death, MI, ischemic stroke/TIA or life threatening/major bleeding
Time Frame: 30 days
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30 days
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Incidence of MI or ischemic stroke
Time Frame: At 30 days and at 12-month follow-up
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At 30 days and at 12-month follow-up
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Incidence of major bleeding
Time Frame: At 30 days and at 12-month follow-up
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At 30 days and at 12-month follow-up
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Cardiovascular death
Time Frame: At 30 days and at 12-month follow-up
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At 30 days and at 12-month follow-up
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Cost-effectiveness of clopidogrel on top of aspirin following TAVI
Time Frame: At 30 days and at 12-month follow-up
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At 30 days and at 12-month follow-up
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Rate of minor bleeding
Time Frame: At 30 days and at 12-month follow-up
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At 30 days and at 12-month follow-up
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Leon MB, Smith CR, Mack M, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Brown DL, Block PC, Guyton RA, Pichard AD, Bavaria JE, Herrmann HC, Douglas PS, Petersen JL, Akin JJ, Anderson WN, Wang D, Pocock S; PARTNER Trial Investigators. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010 Oct 21;363(17):1597-607. doi: 10.1056/NEJMoa1008232. Epub 2010 Sep 22.
- Lip GY, Nieuwlaat R, Pisters R, Lane DA, Crijns HJ. Refining clinical risk stratification for predicting stroke and thromboembolism in atrial fibrillation using a novel risk factor-based approach: the euro heart survey on atrial fibrillation. Chest. 2010 Feb;137(2):263-72. doi: 10.1378/chest.09-1584. Epub 2009 Sep 17.
- Rodes-Cabau J. [Progress in transcatheter aortic valve implantation]. Rev Esp Cardiol. 2010 Apr;63(4):439-50. Spanish.
- Thomas M, Schymik G, Walther T, Himbert D, Lefevre T, Treede H, Eggebrecht H, Rubino P, Michev I, Lange R, Anderson WN, Wendler O. Thirty-day results of the SAPIEN aortic Bioprosthesis European Outcome (SOURCE) Registry: A European registry of transcatheter aortic valve implantation using the Edwards SAPIEN valve. Circulation. 2010 Jul 6;122(1):62-9. doi: 10.1161/CIRCULATIONAHA.109.907402. Epub 2010 Jun 21.
- Rodes-Cabau J, Webb JG, Cheung A, Ye J, Dumont E, Feindel CM, Osten M, Natarajan MK, Velianou JL, Martucci G, DeVarennes B, Chisholm R, Peterson MD, Lichtenstein SV, Nietlispach F, Doyle D, DeLarochelliere R, Teoh K, Chu V, Dancea A, Lachapelle K, Cheema A, Latter D, Horlick E. Transcatheter aortic valve implantation for the treatment of severe symptomatic aortic stenosis in patients at very high or prohibitive surgical risk: acute and late outcomes of the multicenter Canadian experience. J Am Coll Cardiol. 2010 Mar 16;55(11):1080-90. doi: 10.1016/j.jacc.2009.12.014. Epub 2010 Jan 22.
- Gurvitch R, Wood DA, Tay EL, Leipsic J, Ye J, Lichtenstein SV, Thompson CR, Carere RG, Wijesinghe N, Nietlispach F, Boone RH, Lauck S, Cheung A, Webb JG. Transcatheter aortic valve implantation: durability of clinical and hemodynamic outcomes beyond 3 years in a large patient cohort. Circulation. 2010 Sep 28;122(13):1319-27. doi: 10.1161/CIRCULATIONAHA.110.948877. Epub 2010 Sep 13.
- Shehab N, Sperling LS, Kegler SR, Budnitz DS. National estimates of emergency department visits for hemorrhage-related adverse events from clopidogrel plus aspirin and from warfarin. Arch Intern Med. 2010 Nov 22;170(21):1926-33. doi: 10.1001/archinternmed.2010.407.
- ACTIVE Investigators; Connolly SJ, Pogue J, Hart RG, Hohnloser SH, Pfeffer M, Chrolavicius S, Yusuf S. Effect of clopidogrel added to aspirin in patients with atrial fibrillation. N Engl J Med. 2009 May 14;360(20):2066-78. doi: 10.1056/NEJMoa0901301. Epub 2009 Mar 31.
- Hansen ML, Sorensen R, Clausen MT, Fog-Petersen ML, Raunso J, Gadsboll N, Gislason GH, Folke F, Andersen SS, Schramm TK, Abildstrom SZ, Poulsen HE, Kober L, Torp-Pedersen C. Risk of bleeding with single, dual, or triple therapy with warfarin, aspirin, and clopidogrel in patients with atrial fibrillation. Arch Intern Med. 2010 Sep 13;170(16):1433-41. doi: 10.1001/archinternmed.2010.271.
- Delaney JA, Opatrny L, Brophy JM, Suissa S. Drug drug interactions between antithrombotic medications and the risk of gastrointestinal bleeding. CMAJ. 2007 Aug 14;177(4):347-51. doi: 10.1503/cmaj.070186.
- Leon MB, Piazza N, Nikolsky E, Blackstone EH, Cutlip DE, Kappetein AP, Krucoff MW, Mack M, Mehran R, Miller C, Morel MA, Petersen J, Popma JJ, Takkenberg JJ, Vahanian A, van Es GA, Vranckx P, Webb JG, Windecker S, Serruys PW. Standardized endpoint definitions for transcatheter aortic valve implantation clinical trials: a consensus report from the Valve Academic Research Consortium. Eur Heart J. 2011 Jan;32(2):205-17. doi: 10.1093/eurheartj/ehq406. Epub 2011 Jan 6.
- Rodes-Cabau J, Masson JB, Welsh RC, Garcia Del Blanco B, Pelletier M, Webb JG, Al-Qoofi F, Genereux P, Maluenda G, Thoenes M, Paradis JM, Chamandi C, Serra V, Dumont E, Cote M. Aspirin Versus Aspirin Plus Clopidogrel as Antithrombotic Treatment Following Transcatheter Aortic Valve Replacement With a Balloon-Expandable Valve: The ARTE (Aspirin Versus Aspirin + Clopidogrel Following Transcatheter Aortic Valve Implantation) Randomized Clinical Trial. JACC Cardiovasc Interv. 2017 Jul 10;10(13):1357-1365. doi: 10.1016/j.jcin.2017.04.014. Epub 2017 May 17.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
March 1, 2012
Primary Completion (ACTUAL)
March 1, 2015
Study Completion (ACTUAL)
March 1, 2016
Study Registration Dates
First Submitted
March 19, 2012
First Submitted That Met QC Criteria
March 20, 2012
First Posted (ESTIMATE)
March 21, 2012
Study Record Updates
Last Update Posted (ACTUAL)
May 11, 2017
Last Update Submitted That Met QC Criteria
May 10, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Ischemia
- Pathologic Processes
- Necrosis
- Myocardial Ischemia
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Heart Valve Diseases
- Myocardial Infarction
- Infarction
- Aortic Valve Disease
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Fibrinolytic Agents
- Fibrin Modulating Agents
- Platelet Aggregation Inhibitors
- Cyclooxygenase Inhibitors
- Antipyretics
- Purinergic P2Y Receptor Antagonists
- Purinergic P2 Receptor Antagonists
- Purinergic Antagonists
- Purinergic Agents
- Aspirin
- Clopidogrel
Other Study ID Numbers
- ARTE
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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