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

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)

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.

Study Overview

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

Enrollment (Actual)

178

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

      • Quebec, Canada, G1V 4G5
        • IUCPQ
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 1Y6
        • St-Paul's Hospital

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 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

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
  • Masking: NONE

Arms and Interventions

Participant Group / 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.
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)
Aspirin (80 mg/d) Aspirin therapy will start at least 24 hrs before the TAVI procedure and continued for at least 6 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of death, MI, ischemic stroke/Transient ischemic attack (TIA) or life threatening/major bleeding
Time Frame: 12-month follow-up
12-month follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of death, MI, ischemic stroke/TIA or life threatening/major bleeding
Time Frame: 30 days
30 days
Incidence of MI or ischemic stroke
Time Frame: At 30 days and at 12-month follow-up
At 30 days and at 12-month follow-up
Incidence of major bleeding
Time Frame: At 30 days and at 12-month follow-up
At 30 days and at 12-month follow-up
Cardiovascular death
Time Frame: At 30 days and at 12-month follow-up
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
At 30 days and at 12-month follow-up
Rate of minor bleeding
Time Frame: At 30 days and at 12-month follow-up
At 30 days and at 12-month follow-up

Collaborators and Investigators

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

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)

March 1, 2012

Primary Completion (ACTUAL)

March 1, 2015

Study Completion (ACTUAL)

March 1, 2016

Study Registration Dates

First Submitted

March 19, 2012

First Submitted That Met QC Criteria

March 20, 2012

First Posted (ESTIMATE)

March 21, 2012

Study Record Updates

Last Update Posted (ACTUAL)

May 11, 2017

Last Update Submitted That Met QC Criteria

May 10, 2017

Last Verified

May 1, 2017

More Information

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 Aspirin (80 mg/d) + clopidogrel (75 mg/d)

3
Subscribe