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Trial record 16 of 412 for:    ASPIRIN AND clopidogrel AND Purinergic Antagonists

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

Tracking Information
First Submitted Date  ICMJE March 19, 2012
First Posted Date  ICMJE March 21, 2012
Last Update Posted Date May 11, 2017
Actual Study Start Date  ICMJE March 2012
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 20, 2012)
Incidence of death, MI, ischemic stroke/Transient ischemic attack (TIA) or life threatening/major bleeding [ Time Frame: 12-month follow-up ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01559298 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 20, 2012)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Aspirin Versus Aspirin + ClopidogRel Following Transcatheter Aortic Valve Implantation: the ARTE Trial
Official Title  ICMJE 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)
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Aortic Valve Disease
  • Myocardial Infarction
  • Stroke
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Aspirin (80 mg/d) + clopidogrel (75 mg/d)
  • Active Comparator: Aspirin
    Patients will be randomized within the month prior to the TAVI procedure to receive aspirin (80 mg/d)
    Intervention: Drug: Aspirin
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 10, 2017)
178
Original Estimated Enrollment  ICMJE
 (submitted: March 20, 2012)
200
Actual Study Completion Date  ICMJE March 2016
Actual Primary Completion Date March 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01559298
Other Study ID Numbers  ICMJE ARTE
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Josep Rodes-Cabau, Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Study Sponsor  ICMJE Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Collaborators  ICMJE Edwards Lifesciences
Investigators  ICMJE
Principal Investigator: Josep Rodes-Cabau, MD IUCPQ
Principal Investigator: John Webb, MD St. Paul's Hospital
PRS Account Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP