Clinical trial NCT02640794: Aspirin Versus Aspirin+Clopidogrel as Antithrombotic Treatment Following TAVI
Official title: Aspirin Versus Aspirin + ClopidogRel as Antithrombotic Treatment Following Transcatheter Aortic Valve Implantation With the Edwards Valve. A Randomized Study (the ARTE Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Aortic Valve Disease
Myocardial Infarction
Stroke
Bleeding
Keywords: Transcatheter aortic valve implantation
Antithrombotic treatment
Clopidogrel
Aspirin/acetylsalicylic acid
Myocardial Infarction
Ischemic stroke
Major bleeding
Lead sponsor: Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Sponsor class: OTHER
First posted: 2015-12-29
Enrollment: 222
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to compare aspirin/acetylsalicylic acid+ clopidogrel with aspirin/acetylsalicylic acid alone as antithrombotic treatment following TAVI for the prevention of major ischemic events (MI, ischemic stroke) or death without increasing the risk of major bleeding events.

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 vs. 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 randomized study to evaluate the efficacy and safety of aspirin/acetylsalicylic acid versus aspirin/acetylsalicylic acid+ clopidogrel as antithrombotic treatment after TAVI.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing a TAVI procedure with the Edwards valve.

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/acetylsalicylic acid

Primary outcomes:
measure: Incidence of death, MI, ischemic stroke/Transient ischemic attack (TIA) or life threatening/major bleeding at 3-month follow-up.
timeFrame: 3-month follow-up
Secondary outcomes:
measure: Incidence of death, MI, ischemic stroke/TIA or life threatening/major bleeding at 30 days
timeFrame: 30 days
measure: Incidence of death, MI, ischemic stroke/TIA or life threatening/major bleeding at at 12-month follow-up
timeFrame: 12-month follow-up
measure: Incidence of MI or ischemic stroke at 30 days and at 12-month follow-up
timeFrame: 12-month follow-up
measure: Cardiovascular death at 30 days and at 12-month follow-up
timeFrame: 30 days and at 12-month follow-up
measure: Cost-effectiveness of clopidogrel on top of aspirin/acetylsalicylic acid following TAVI
timeFrame: 30 days and at 12-month follow-up
measure: Rate of minor bleeding at 30 days and at 12-month follow-up
timeFrame: 30 days and at 12-month follow-up
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: St Michael's Hospital
state: Ontario
city: Quebec
country: Canada
facility: Institut Universitaire de Cardiologie et de Pneumologie de Quebec
city: Santiago
country: Chile
facility: Hospital San Borja Arriaran
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron de Barcelona
Study officials:
affiliation: Fondation IUCPQ
name: Josep Rodes, MD
role: PRINCIPAL_INVESTIGATOR
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