NCT01014273

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7,021

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jun 2006

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

November 13, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 16, 2009

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

April 7, 2011

Status Verified

February 1, 2011

Enrollment Period

4.7 years

First QC Date

November 13, 2009

Last Update Submit

April 6, 2011

Conditions

Acute Coronary SyndromePercutaneous Coronary Intervention

Keywords

Acute Coronary SyndromePCIPercutaneous Coronary InterventionRadial Access

Outcome Measures

Primary Outcomes (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.

    30 days

Secondary Outcomes (2)

  • Non CABG major bleeding

    within 30 days following randomization

  • Death, MI or stroke

    within 30 days following randomization

Study Arms (2)

Trans-femoral access

ACTIVE COMPARATOR

Femoral artery PCI access site

Procedure: Percutaneous Coronary Intervention

Trans-radial access

ACTIVE COMPARATOR

Radial artery PCI access site

Procedure: Percutaneous Coronary Intervention

Interventions

Percutaneous Coronary InterventionPROCEDURE
Trans-femoral accessTrans-radial access

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 \[ST depression of at least 1mm or transient ST elevation or ST elevation of less than or equal to 1 mm or T wave inversion greater than 2 mm in at least 2 contiguous leads\].
  • 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.
  • 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
  • +1 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hamilton Health Sciences

Hamilton, Ontario, L8L 2X2, Canada

Location

Related Publications (6)

  • 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.

    PMID: 26542495DERIVED

  • 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.

    PMID: 24269362DERIVED

  • 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.

    PMID: 23517837DERIVED

  • 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.

    PMID: 23103036DERIVED

  • 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.

    PMID: 21470671DERIVED

  • 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.

    PMID: 21315206DERIVED

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Endovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Officials

  • Sanjit Jolly, MD, MSc, FRCPC

    Population Health Research Institute

    PRINCIPAL INVESTIGATOR

  • Susan Chrolavicius

    Population Health Research Institute

    STUDY DIRECTOR

  • Shamir Mehta, MD, MSc, FRCP(C), FACC

    Population Health Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 13, 2009

First Posted

November 16, 2009

Study Start

June 1, 2006

Primary Completion

February 1, 2011

Study Completion

March 1, 2011

Last Updated

April 7, 2011

Record last verified: 2011-02

Locations

CA(1)