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)

April 6, 2011 updated by: Population Health Research Institute

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
7021

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

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
    • Ontario
      • Hamilton, Ontario, Canada, L8L 2X2
        • Hamilton Health Sciences

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
30 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Non CABG major bleeding
Time Frame: within 30 days following randomization
within 30 days following randomization
Death, MI or stroke
Time Frame: within 30 days following randomization
within 30 days following randomization

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Population Health Research Institute

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Sanofi

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2006

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2011

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 13, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 13, 2009

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 16, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 7, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 6, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Rad-Fem PCI Access Study

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.

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