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
  Purpose

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 Intervention Phase
Acute Coronary Syndrome
Percutaneous Coronary Intervention
Procedure: Percutaneous Coronary Intervention
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Population Health Research Institute:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 7021
Study Start Date: June 2006
Study Completion Date: March 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01014273

Locations
Canada, Ontario
Hamilton Health Sciences
Hamilton, Ontario, Canada, L8L 2X2
Sponsors and Collaborators
Population Health Research Institute
Sanofi
Investigators
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

Additional Information:
No publications provided by Population Health Research Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Sanjit Jolly, MD, MSc, FRCPC, Population Health Research Institute
ClinicalTrials.gov Identifier: NCT01014273     History of Changes
Other Study ID Numbers: Rad-Fem PCI Access Study
Study First Received: November 13, 2009
Last Updated: April 6, 2011
Health Authority: Canada: Ethics Review Committee
United States: Institutional Review Board
Czech Republic: Ethics Committee
Finland: Ethics Committee
Hungary: National Institute of Pharmacy
Slovenia: Ethics Committee
Australia: Human Research Ethics Committee
France: Institutional Ethical Committee
India: Institutional Review Board
Italy: Ethics Committee
New Zealand: Institutional Review Board
Poland: Ethics Committee
Spain: Ethics Committee
Bulgaria: Ministry of Health
Brazil: Ethics Committee
Chile: Instituto de Salud Pública de Chile
Israel: Ministry of Health
Malaysia: Ministry of Health

Keywords provided by Population Health Research Institute:
Acute Coronary Syndrome
PCI
Percutaneous Coronary Intervention
Radial Access

Additional relevant MeSH terms:
Angina, Unstable
Infarction
Myocardial Infarction
Acute Coronary Syndrome
Angina Pectoris
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Ischemia
Pathologic Processes
Necrosis

ClinicalTrials.gov processed this record on July 24, 2014