Don't get left behind! The modernized ClinicalTrials.gov is coming. Check it out now.
Say goodbye to ClinicalTrials.gov!
The new site is coming soon - go to the modernized ClinicalTrials.gov
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Trial of Trans-radial Versus Trans-femoral Percutaneous Coronary Intervention (PCI) Access Site Approach in Patients With Unstable Angina or Myocardial Infarction Managed With an Invasive Strategy (RIVAL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01014273
Recruitment Status : Completed
First Posted : November 16, 2009
Last Update Posted : April 7, 2011
Sponsor:
Collaborator:
Sanofi
Information provided by:
Population Health Research Institute

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

This is a multi-national, multi-centre, randomized study comparing the trans-radial PCI access strategy and the trans-femoral PCI access strategy in ACS patients with UA or NSTEMI or STEMI planned to be treated with an invasive strategy (PCI).

The hypothesis is that radial access site PCI will be associated with significantly less major bleeding and access site complications compared with a femoral approach, without increasing the risk of ischemic events. The overall benefit-risk profile will favor a trans-radial approach.


Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome Percutaneous Coronary Intervention Procedure: Percutaneous Coronary Intervention Phase 3

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7021 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An International Randomized Trial of Trans-radial Versus Trans-femoral PCI Access Site Approach in Patients With Unstable Angina or Myocardial Infarction Managed With an Invasive Strategy. An Extension to the CURRENT (OASIS 7) Substudy (EFC5695): Effect of Type of Access for PCI (Radial or Femoral) on Bleeding Rate-Substudy.
Study Start Date : June 2006
Actual Primary Completion Date : February 2011
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: Trans-femoral access
Femoral artery PCI access site
 Procedure: Percutaneous Coronary Intervention
Active Comparator: Trans-radial access
Radial artery PCI access site
 Procedure: Percutaneous Coronary Intervention


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. First occurrence of the composite of death, MI, stroke or non CABG major bleeding (i.e. severe bleeding, other major bleeding) at 30 days. [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. Non CABG major bleeding [ Time Frame: within 30 days following randomization ]
  2. Death, MI or stroke [ Time Frame: within 30 days following randomization ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA

1.1 UA/NSTEMI patients

Ischemic symptoms suspected to represent a non-ST segment elevation ACS (unstable angina [UA] or non-ST segment elevation myocardial infarction NSTEMI) defined as:

Clinical history consistent with new onset, or a worsening pattern, of characteristic ischemic chest pain occurring at rest or with minimal exercise (lasting longer than 10 minutes) and planned to be managed with an invasive strategy

AND at least one of the following:

  1. Electrocardiogram (ECG) changes compatible with new ischemia [ST depression of at least 1mm or transient ST elevation or ST elevation of less than or equal to 1 mm or T wave inversion greater than 2 mm in at least 2 contiguous leads].

    or

  2. Patients > 60 years of age with normal ECG are eligible provided there is a high degree of certainty that presenting symptoms are due to myocardial ischemia. Such patients must have documented evidence of previous coronary artery disease (CAD) with at least one of the following:

    • Prior MI requiring hospitalization
    • Prior revascularization procedure (more than 3 months ago)
    • Cardiac catheterization showing significant CAD
    • Positive exercise test
    • Other objective evidence of atherosclerotic vascular disease or
  3. Already elevated cardiac enzymes or troponin I or T above the upper limit of normal.

1.2 STEMI patients

  1. Presenting with signs or symptoms of acute myocardial infarction lasting at least 20 minutes and planned to be managed with an invasive strategy with intent to perform a percutaneous coronary intervention (PCI) during the index hospitalization.

  2. Definite ECG changes compatible with STEMI: persistent ST-elevation (> 2 mm in two contiguous precordial leads or > 1 mm in at least two limb leads), or new left bundle branch block, or Q-wave in 2 contiguous leads

    2) Randomized during index hospitalization for acute coronary syndrome 3) Suitable candidate for either radial or femoral artery PCI 4) Intent to perform same-sitting angiography and PCI. 5) Palpable radial artery with documented normal Allen's test 6) Acceptance by operator to use whichever route is assigned by the randomization process 7) Previous experience of the operator with at least 50 cases of radial artery access within the past year 8) Written informed consent

    EXCLUSION CRITERIA

    1. Age < 18 years
    2. Active bleeding or significant increased risk of bleeding, severe hepatic insufficiency, current peptic ulceration, proliferative diabetic retinopathy.
    3. Uncontrolled hypertension
    4. Cardiogenic shock
    5. Prior CABG surgery with use of more than one internal mammary artery
    6. Documented severe peripheral vascular disease precluding a femoral approach
    7. Participation in any study with an investigational drug or device within the previous 30 days
    8. Medical, geographic or social factors making study participation impractical
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT01014273


Locations
Layout table for location information
Canada, Ontario
Hamilton Health Sciences
Hamilton, Ontario, Canada, L8L 2X2
Sponsors and Collaborators
Population Health Research Institute
Sanofi
Investigators
Layout table for investigator information
Principal Investigator: Sanjit Jolly, MD, MSc, FRCPC Population Health Research Institute
Study Director: Susan Chrolavicius Population Health Research Institute
Principal Investigator: Shamir Mehta, MD, MSc, FRCP(C), FACC Population Health Research Institute
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Sanjit Jolly, MD, MSc, FRCPC, Population Health Research Institute
ClinicalTrials.gov Identifier: NCT01014273    
Other Study ID Numbers: Rad-Fem PCI Access Study
First Posted: November 16, 2009    Key Record Dates
Last Update Posted: April 7, 2011
Last Verified: February 2011
Keywords provided by Population Health Research Institute:
Acute Coronary Syndrome
PCI
Percutaneous Coronary Intervention
Radial Access
Additional relevant MeSH terms:
Layout table for MeSH terms
Myocardial Infarction
Acute Coronary Syndrome
Angina, Unstable
Infarction
Pathologic Processes
Ischemia
Necrosis
Myocardial Ischemia
 Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Angina Pectoris
Chest Pain
Pain
Neurologic Manifestations