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Aspirin Versus Aspirin + ClopidogRel Following Transcatheter Aortic Valve Implantation: the ARTE Trial (ARTE)

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ClinicalTrials.gov Identifier: NCT01559298
Recruitment Status : Completed
First Posted : March 21, 2012
Last Update Posted : May 11, 2017
Sponsor:
Collaborator:
Edwards Lifesciences
Information provided by (Responsible Party):
Josep Rodes-Cabau, Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Aortic Valve Disease Myocardial Infarction Stroke Drug: Aspirin (80 mg/d) + clopidogrel (75 mg/d) Drug: Aspirin Phase 4

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  (Clinical Trial)
Actual Enrollment : 178 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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)
Actual Study Start Date : March 2012
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine


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.
Drug: Aspirin (80 mg/d) + clopidogrel (75 mg/d)
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.

Active Comparator: Aspirin
Patients will be randomized within the month prior to the TAVI procedure to receive aspirin (80 mg/d)
Drug: Aspirin
Aspirin (80 mg/d) Aspirin therapy will start at least 24 hrs before the TAVI procedure and continued for at least 6 months.




Primary Outcome Measures :
  1. Incidence of death, MI, ischemic stroke/Transient ischemic attack (TIA) or life threatening/major bleeding [ Time Frame: 12-month follow-up ]

Secondary Outcome Measures :
  1. Incidence of death, MI, ischemic stroke/TIA or life threatening/major bleeding [ Time Frame: 30 days ]
  2. Incidence of MI or ischemic stroke [ Time Frame: At 30 days and at 12-month follow-up ]
  3. Incidence of major bleeding [ Time Frame: At 30 days and at 12-month follow-up ]
  4. Cardiovascular death [ Time Frame: At 30 days and at 12-month follow-up ]
  5. Cost-effectiveness of clopidogrel on top of aspirin following TAVI [ Time Frame: At 30 days and at 12-month follow-up ]
  6. Rate of minor bleeding [ Time Frame: At 30 days and at 12-month follow-up ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01559298


Locations
Canada, British Columbia
St-Paul's Hospital
Vancouver, British Columbia, Canada, V6Z 1Y6
Canada
IUCPQ
Quebec, Canada, G1V 4G5
Sponsors and Collaborators
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Edwards Lifesciences
Investigators
Principal Investigator: Josep Rodes-Cabau, MD IUCPQ
Principal Investigator: John Webb, MD St. Paul's Hospital

Publications:

Responsible Party: Josep Rodes-Cabau, MD, Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
ClinicalTrials.gov Identifier: NCT01559298     History of Changes
Other Study ID Numbers: ARTE
First Posted: March 21, 2012    Key Record Dates
Last Update Posted: May 11, 2017
Last Verified: May 2017

Keywords provided by Josep Rodes-Cabau, Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec:
Transcatheter aortic valve implantation
Antithrombotic treatment
Clopidogrel
Aspirin
Myocardial Infarction
Ischemic stroke
Major bleeding

Additional relevant MeSH terms:
Aspirin
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Ticlopidine
Clopidogrel
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists