A Phase 4 interventional study of Aspirin (80 mg/d) + clopidogrel (75 mg/d) and Aspirin in Aortic Valve Disease, Myocardial Infarction and Stroke, sponsored by Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec. Completed at 2 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-05-11.
Sponsored by Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec · Phase 4, Interventional, and Prevention
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.
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.
2,744 studies on the registry are indexed under Myocardial Infarction; 418 are open to participants now.
This study's enrollment of 178 is above the median of 148 across 1,595 interventional studies indexed under Myocardial Infarction.
Browse Myocardial Infarction studies →Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec is the lead sponsor of 23 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
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.
Drug: Aspirin (80 mg/d) + clopidogrel (75 mg/d)
Patients will be randomized within the month prior to the TAVI procedure to receive aspirin (80 mg/d)
Drug: Aspirin
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.
Aspirin (80 mg/d) Aspirin therapy will start at least 24 hrs before the TAVI procedure and continued for at least 6 months.
Incidence of death, MI, ischemic stroke/Transient ischemic attack (TIA) or life threatening/major bleeding
Time frame: 12-month follow-up
Incidence of death, MI, ischemic stroke/TIA or life threatening/major bleeding
Time frame: 30 days
Incidence of MI or ischemic stroke
Time frame: At 30 days and at 12-month follow-up
Incidence of major bleeding
Time frame: At 30 days and at 12-month follow-up
Cardiovascular death
Time frame: At 30 days and at 12-month follow-up
Cost-effectiveness of clopidogrel on top of aspirin following TAVI
Time frame: At 30 days and at 12-month follow-up
Rate of minor bleeding
Time frame: At 30 days and at 12-month follow-up
This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec