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Aspirin Versus Aspirin+Clopidogrel as Antithrombotic Treatment Following TAVI (ARTE)

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ClinicalTrials.gov Identifier: NCT02640794
Recruitment Status : Completed
First Posted : December 29, 2015
Last Update Posted : July 17, 2018
Sponsor:
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/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.

Condition or disease Intervention/treatment Phase
Aortic Valve Disease Myocardial Infarction Stroke Bleeding Drug: Clopidogrel 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 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 222 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 Valve. A Randomized Study (the ARTE Trial)
Actual Study Start Date : January 2015
Actual Primary Completion Date : June 2017
Actual Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
Active Comparator: Aspirin +clopidogrel
Patients would be randomized within the month prior to the TAVI procedure to receive aspirin/acetylsalicylic acid (80-325 mg/d) + clopidogrel (75 mg/d)
Drug: Clopidogrel
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.
Other Name: Plavix

Drug: Aspirin
Aspirin/acetylsalicylic acid (80-325 mg/d). Aspirin/acetylsalicylic acid therapy will start at least 24 hrs before the TAVI procedure and continued for at least 6 months.
Other Name: Acetylsalicylic acid

Active Comparator: Aspirin
Patients will be randomized within the month prior to the TAVI procedure to receive aspirin/acetylsalicylic acid (80-325 mg/d)
Drug: Aspirin
Aspirin/acetylsalicylic acid (80-325 mg/d). Aspirin/acetylsalicylic acid therapy will start at least 24 hrs before the TAVI procedure and continued for at least 6 months.
Other Name: Acetylsalicylic acid




Primary Outcome Measures :
  1. Incidence of death, MI, ischemic stroke/Transient ischemic attack (TIA) or life threatening/major bleeding at 3-month follow-up. [ Time Frame: 3-month follow-up ]
    The composite endpoint of incidence of death, MI, ischemic stroke/Transient ischemic attack (TIA) or life life threatening/major bleeding at 3-month follow-up will be analyzed


Secondary Outcome Measures :
  1. Incidence of death, MI, ischemic stroke/TIA or life threatening/major bleeding at 30 days [ Time Frame: 30 days ]
    The composite endpoint of Incidence of death, MI, ischemic stroke/TIA or life threatening/major bleeding at 30 days will be analyzed

  2. Incidence of death, MI, ischemic stroke/TIA or life threatening/major bleeding at at 12-month follow-up [ Time Frame: 12-month follow-up ]
    The composite endpoint of Incidence of death, MI, ischemic stroke/TIA or life threatening/major bleeding at at 12-month follow-up will be analyzed.

  3. Incidence of MI or ischemic stroke at 30 days and at 12-month follow-up [ Time Frame: 12-month follow-up ]
    The composite endpoint of incidence of MI or ischemic stroke at 30 days and at 12-month follow-up will be analyzed

  4. Cardiovascular death at 30 days and at 12-month follow-up [ Time Frame: 30 days and at 12-month follow-up ]
    The incidence of cardiovascular death at 30 days and at 12-month follow-up will be analyzed

  5. Cost-effectiveness of clopidogrel on top of aspirin/acetylsalicylic acid following TAVI [ Time Frame: 30 days and at 12-month follow-up ]
    Cost-effectiveness of clopidogrel on top of aspirin/acetylsalicylic acid following TAVI will be analyzed

  6. Rate of minor bleeding at 30 days and at 12-month follow-up [ Time Frame: 30 days and at 12-month follow-up ]
    Rate of minor bleeding at 30 days and at 12-month follow-up will be analyzed



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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 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

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): NCT02640794


Locations
Canada, Ontario
St Michael's Hospital
Toronto, Ontario, Canada
Canada
Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Quebec, Canada, G1V 4G5
Chile
Hospital San Borja Arriaran
Santiago, Chile
Spain
Hospital Vall d'Hebron de Barcelona
Barcelona, Spain
Sponsors and Collaborators
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Investigators
Principal Investigator: Josep Rodes, MD IUCPQ

Publications of Results:

Responsible Party: Josep Rodes-Cabau, MD, Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
ClinicalTrials.gov Identifier: NCT02640794     History of Changes
Other Study ID Numbers: ARTE2
First Posted: December 29, 2015    Key Record Dates
Last Update Posted: July 17, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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/acetylsalicylic acid
Myocardial Infarction
Ischemic stroke
Major bleeding

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Hemorrhage
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Aspirin
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