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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)

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by:
Population Health Research Institute
ClinicalTrials.gov Identifier:
NCT01014273
First received: November 13, 2009
Last updated: April 6, 2011
Last verified: February 2011

November 13, 2009
April 6, 2011
June 2006
February 2011   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
First occurrence of the composite of death, MI, stroke or major bleeding (i.e. severe bleeding, other major bleeding) at 30 days. [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01014273 on ClinicalTrials.gov Archive Site
  • Non CABG major bleeding [ Time Frame: within 30 days following randomization ] [ Designated as safety issue: Yes ]
  • Death, MI or stroke [ Time Frame: within 30 days following randomization ] [ Designated as safety issue: No ]
  • Major bleeding at 48 hours and 30 days after the procedure [ Time Frame: 48 hours and 30 days post-procedure ] [ Designated as safety issue: Yes ]
  • Major vascular access site complications at 48 hours and 30 days after the procedure [ Time Frame: 48 hours and 30 days post-procedure ] [ Designated as safety issue: No ]
  • Composite of death, MI or stroke and each component taken separately at 48 hours and 30 days [ Time Frame: 48 hours and 30 days ] [ Designated as safety issue: No ]
  • Composite of death, MI, stroke, or non-CABG related major bleeding at 30 days [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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
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.

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Acute Coronary Syndrome
  • Percutaneous Coronary Intervention
Procedure: Percutaneous Coronary Intervention
  • Active Comparator: Trans-femoral access
    Femoral artery PCI access site
    Intervention: Procedure: Percutaneous Coronary Intervention
  • Active Comparator: Trans-radial access
    Radial artery PCI access site
    Intervention: Procedure: Percutaneous Coronary Intervention

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
7021
March 2011
February 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01014273
Rad-Fem PCI Access Study
Yes
Sanjit Jolly, MD, MSc, FRCPC, Population Health Research Institute
Population Health Research Institute
Sanofi
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
Population Health Research Institute
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP