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

July 16, 2018 updated by: Josep Rodes-Cabau, Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

Aspirin Versus Aspirin + ClopidogRel as Antithrombotic Treatment Following Transcatheter Aortic Valve Implantation With the Edwards Valve. A Randomized Study (the ARTE Trial)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

222

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Quebec, Canada, G1V 4G5
        • Institut Universitaire de cardiologie et de pneumologie de Quebec
    • Ontario
      • Toronto, Ontario, Canada
        • St Michael's Hospital
  • Chile
      • Santiago, Chile
        • Hospital San Borja Arriarán
  • Spain
      • Barcelona, Spain
        • Hospital Vall d'Hebron de Barcelona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • 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 Names:
  • Acetylsalicylic acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3-month follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
30 days
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.
12-month follow-up
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
12-month follow-up
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
30 days and at 12-month follow-up
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
30 days and at 12-month follow-up
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
30 days and at 12-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

Investigators

  • Principal Investigator: Josep Rodes, MD, Fondation IUCPQ

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2015

Primary Completion (Actual)

June 1, 2017

Study Completion (Actual)

March 1, 2018

Study Registration Dates

First Submitted

December 23, 2015

First Submitted That Met QC Criteria

December 23, 2015

First Posted (Estimate)

December 29, 2015

Study Record Updates

Last Update Posted (Actual)

July 17, 2018

Last Update Submitted That Met QC Criteria

July 16, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ARTE2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Myocardial Infarction

Clinical Trials on Clopidogrel

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Qatar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe