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Acute Coronary SyndromePhase 3RIVALNCT01014273

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

A Phase 3 study testing Percutaneous Coronary Intervention in people with Acute Coronary Syndrome and Percutaneous Coronary Intervention, run by Population Health Research Institute at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Percutaneous Coronary Intervention
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
7,021 participants
Where
1 siteCanada
Study dates
Jun 2006to Mar 2011
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
  • 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
Show all 17Show fewer
  • 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
  • Already elevated cardiac enzymes or troponin I or T above the upper limit of normal.
  • 1.2 STEMI patients
  • 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.
  • 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

Who cannot join

  • Age < 18 years
  • Active bleeding or significant increased risk of bleeding, severe hepatic insufficiency, current peptic ulceration, proliferative diabetic retinopathy.
  • Uncontrolled hypertension
  • Cardiogenic shock
  • Prior CABG surgery with use of more than one internal mammary artery
  • Documented severe peripheral vascular disease precluding a femoral approach
  • Participation in any study with an investigational drug or device within the previous 30 days
  • Medical, geographic or social factors making study participation impractical

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Hamilton Health Sciences

    Hamilton, Ontario, L8L 2X2

Other trials in Canada

About this study

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.

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.

Being tested
Percutaneous Coronary Intervention
Keywords
Acute Coronary Syndrome, PCI, Percutaneous Coronary Intervention, Radial Access
Medical subject headings
Acute Coronary Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Percutaneous Coronary InterventionProcedure or surgery

Study groups in NCT01014273
Study groupRoleWhat they receive
Trans-femoral accessActive comparatorFemoral artery PCI access site
Receives: Procedure: Percutaneous Coronary Intervention
Trans-radial accessActive comparatorRadial artery PCI access site
Receives: Procedure: Percutaneous Coronary Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 30 days

Secondary outcomes (2)

  1. Non CABG major bleeding

    Measured: within 30 days following randomization

  2. Death, MI or stroke

    Measured: within 30 days following randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Nov 2009 (estimated)
  2. Study startJun 2006
  3. Primary completionFeb 2011
  4. Study completionMar 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
7,021 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01014273
Sponsor's protocol ID
Rad-Fem PCI Access Study
Acronym
RIVAL
Status last verified
Feb 2011
First submitted
13 Nov 2009
Last updated
7 Apr 2011
Results posted
No
Data monitoring committee
Yes

Publications

  • Cantor WJ, Mehta SR, Yuan F, Dzavik V, Worthley M, Niemela K, Valentin V, Fung A, Cheema AN, Widimsky P, Natarajan M, Jedrzejowski B, Jolly SS. Radial versus femoral access for elderly patients with acute coronary syndrome undergoing coronary angiography and intervention: insights from the RIVAL trial. Am Heart J. 2015 Nov;170(5):880-6. doi: 10.1016/j.ahj.2015.08.011. Epub 2015 Aug 16.

    PubMed 26542495

  • Jolly SS, Cairns J, Yusuf S, Niemela K, Steg PG, Worthley M, Ferrari E, Cantor WJ, Fung A, Valettas N, Rokoss M, Olivecrona GK, Widimsky P, Cheema AN, Gao P, Mehta SR; RIVAL Investigators. Procedural volume and outcomes with radial or femoral access for coronary angiography and intervention. J Am Coll Cardiol. 2014 Mar 18;63(10):954-63. doi: 10.1016/j.jacc.2013.10.052. Epub 2013 Nov 21.

    PubMed 24269362

  • Jolly SS, Cairns J, Niemela K, Steg PG, Natarajan MK, Cheema AN, Rao SV, Cantor WJ, Dzavik V, Budaj A, Sheth T, Valentin V, Fung A, Widimsky P, Ferrari E, Gao P, Jedrzejowski B, Mehta SR; RIVAL Investigators. Effect of radial versus femoral access on radiation dose and the importance of procedural volume: a substudy of the multicenter randomized RIVAL trial. JACC Cardiovasc Interv. 2013 Mar;6(3):258-66. doi: 10.1016/j.jcin.2012.10.016.

    PubMed 23517837

  • Mehta SR, Jolly SS, Cairns J, Niemela K, Rao SV, Cheema AN, Steg PG, Cantor WJ, Dzavik V, Budaj A, Rokoss M, Valentin V, Gao P, Yusuf S; RIVAL Investigators. Effects of radial versus femoral artery access in patients with acute coronary syndromes with or without ST-segment elevation. J Am Coll Cardiol. 2012 Dec 18;60(24):2490-9. doi: 10.1016/j.jacc.2012.07.050. Epub 2012 Oct 24.

    PubMed 23103036

  • Jolly SS, Yusuf S, Cairns J, Niemela K, Xavier D, Widimsky P, Budaj A, Niemela M, Valentin V, Lewis BS, Avezum A, Steg PG, Rao SV, Gao P, Afzal R, Joyner CD, Chrolavicius S, Mehta SR; RIVAL trial group. Radial versus femoral access for coronary angiography and intervention in patients with acute coronary syndromes (RIVAL): a randomised, parallel group, multicentre trial. Lancet. 2011 Apr 23;377(9775):1409-20. doi: 10.1016/S0140-6736(11)60404-2. Epub 2011 Apr 4.

    PubMed 21470671

  • Jolly SS, Niemela K, Xavier D, Widimsky P, Budaj A, Valentin V, Lewis BS, Avezum A, Steg PG, Rao SV, Cairns J, Chrolavicius S, Yusuf S, Mehta SR. Design and rationale of the radial versus femoral access for coronary intervention (RIVAL) trial: a randomized comparison of radial versus femoral access for coronary angiography or intervention in patients with acute coronary syndromes. Am Heart J. 2011 Feb;161(2):254-260.e1-4. doi: 10.1016/j.ahj.2010.11.021.

    PubMed 21315206

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Percutaneous Coronary Intervention in people with Acute Coronary Syndrome and Percutaneous Coronary Intervention, run by Population Health Research Institute at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01014273, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2011.

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