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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
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
ClinicalTrials.gov Identifier:
NCT01559298
First received: March 19, 2012
Last updated: February 5, 2014
Last verified: February 2014
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec:

Primary Outcome Measures:
  • Incidence of death, MI, ischemic stroke/Transient ischemic attack (TIA) or life threatening/major bleeding [ Time Frame: 12-month follow-up ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Incidence of death, MI, ischemic stroke/TIA or life threatening/major bleeding [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Incidence of MI or ischemic stroke [ Time Frame: At 30 days and at 12-month follow-up ] [ Designated as safety issue: Yes ]
  • Incidence of major bleeding [ Time Frame: At 30 days and at 12-month follow-up ] [ Designated as safety issue: Yes ]
  • Cardiovascular death [ Time Frame: At 30 days and at 12-month follow-up ] [ Designated as safety issue: Yes ]
  • Cost-effectiveness of clopidogrel on top of aspirin following TAVI [ Time Frame: At 30 days and at 12-month follow-up ] [ Designated as safety issue: Yes ]
  • Rate of minor bleeding [ Time Frame: At 30 days and at 12-month follow-up ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: March 2012
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01559298

Locations
Canada, British Columbia
St-Paul's Hospital Recruiting
Vancouver, British Columbia, Canada, V6Z 1Y6
Contact: John Webb, MD    604 806 8804    webb@providencehealth.bc.ca   
Principal Investigator: John Webb, MD         
Canada
IUCPQ Recruiting
Quebec, Canada, G1V 4G5
Contact: Josep Rodes-Cabau, MD    418-656-8711    josep.rodes@criucpq.ulaval.ca   
Contact: Melanie Cote, MSc    418-656-8711    melanie.cote@criucpq.ulaval.ca   
Principal Investigator: Josep Rodes-Cabau, MD         
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
  More Information

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
Study First Received: March 19, 2012
Last Updated: February 5, 2014
Health Authority: Canada: Health Canada

Keywords provided by 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:
Heart Defects, Congenital
Heart Valve Diseases
Infarction
Myocardial Infarction
Cardiovascular Abnormalities
Cardiovascular Diseases
Congenital Abnormalities
Heart Diseases
Ischemia
Myocardial Ischemia
Necrosis
Pathologic Processes
Vascular Diseases
Aspirin
Clopidogrel
Ticlopidine
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antipyretics
Antirheumatic Agents
Cardiovascular Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 23, 2014