NCT01398254

Brief Summary

Primary percutaneous coronary intervention (PPCI) has become the dominant strategy for the treatment of ST-elevation myocardial infarction (STEMI), as studies have shown that PPCI is superior to fibrinolytic therapy. Recent evidence suggests that transradial access (TRA) is superior to transfemoral (TFA) for patients undergoing PPCI. Two large trials report a mortality benefit favouring TRA. The results of these two trials could significantly impact practice guidelines and lead to a recommendation that the approach of choice for primary PCI be radial rather than femoral. This would have significant implications for both PCI centers and interventionalists associated with a large impact on practice and education. Yet, many centers and interventionalists in Canada and in the USA prefer TFA and currently feel pressured in making the change to TRA. With that said, these trials did not include new pharmacotherapy and new technology that would likely have closed or eliminated the gap between TFA and TRA by improving the safety and efficacy of these two approaches. Furthermore, these trials were not powered to conclusively show a mortality benefit. The authors of the two large trials emphasized the need for further trials to confirm the benefits of TRA. The SAFARI-STEMI trial aims to compare TFA with TRA in patients undergoing primary percutaneous intervention (PPCI). The primary outcome will be defined as all cause mortality measured at 30 days. The trial will also evaluate: 1) bleeding events and 2) the composite of death, reinfarction, or stroke defined as major adverse clinical events (MACE). The trial will include the use of antithrombotic therapy with monotherapy, with either bivalirudin or unfractionated heparin; the use of glycoprotein inhibitors IIb/IIIa inhibitors will be avoided. The study will encourage liberal use of vascular closing devices. The trial will also compare delays to reperfusion between the two strategies. Finally, a cost analysis is proposed. In view of recent publications, there is now a need for a large randomized trial using contemporary adjunct therapies to assess the safety and efficacy of the TRA vs. the TFA in PPCI. The proposed trial aims to conclusively show whether there is a survival benefit associated with the TRA approach.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,292

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

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

July 1, 2011

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

July 13, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 20, 2011

Completed
7.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 16, 2019

Completed
Last Updated

January 29, 2019

Status Verified

January 1, 2019

Enrollment Period

7.4 years

First QC Date

July 13, 2011

Last Update Submit

January 25, 2019

Conditions

Myocardial InfarctionSTEMI

Keywords

ST-Elevation Myocardial InfarctionMortality

Outcome Measures

Primary Outcomes (1)

  • All-cause mortality

    The primary outcomes will be all-cause mortality measured at 30 days.

    30 days

Secondary Outcomes (12)

  • Death, reinfarction, or stroke

    30 days and 6 months

  • All-cause mortality

    6 months

  • Reinfarction

    30 days and 6 months

  • Stroke

    30 days and 6 months

  • Stent thrombosis

    30 days and 6 months

  • +7 more secondary outcomes

Study Arms (2)

TRA

OTHER

Transradial Access

Procedure: Primary Percutaneous Coronary Intervention (PPCI)

TFA

OTHER

Transfemoral Access

Procedure: Primary Percutaneous Coronary Intervention (PPCI)

Interventions

Primary Percutaneous Coronary Intervention (PPCI)PROCEDURE

Participants will be randomly assigned an access site, radial or femoral, for PPCI.

TFATRA

Eligibility Criteria

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

You may qualify if:

  • Ischemic chest discomfort of greater or equal to 30 minutes duration,
  • Onset of chest pain of greater or equal to 12 hrs prior to entry into the study,
  • ST segment elevation of \> 1 mm (0.1 mV) in two or more contiguous electrocardiographic leads (on a standard 12 lead ECG) or left bundle branch block not known to be old

You may not qualify if:

  • Age \< 18 yrs
  • Active bleeding
  • Inadequate vascular access from the femoral arteries (i.e. severe peripheral vascular artery disease precluding right or left femoral approach)
  • Abnormal Allen's test precluding either right or left radial approach
  • PCI within the last 30 days
  • Fibrinolytic agents within the last 7 days
  • Warfarin, dabigatran or other oral anticoagulant within the last 7 days
  • Known coagulation disorder (i.e. INR \>2.0, platelets \<100,000 / mm3)
  • Allergy to aspirin
  • Participation in a study with another investigational device or drug \< four weeks
  • Known severe renal impairment (creatinine \>200 umol/L)\*
  • Known severe contrast (dye) allergy
  • Prior coronary artery bypass surgery
  • Inability to provide informed consent
  • Bivalirudin is contraindicated in renal failure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

St. Boniface Hospital

Winnipeg, Manitoba, R2H 2A6, Canada

Location

Saint John Regional Hospital

Saint John, New Brunswick, E2L 4L2, Canada

Location

Queen Elizabeth II Health Sciences Center

Halifax, Nova Scotia, B3H 4G4, Canada

Location

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Location

Thunder Bay Regional Health Sciences Center

Thunder Bay, Ontario, P7B 6V4, Canada

Location

Related Publications (2)

  • Marbach JA, Wells G, Santo PD, So D, Chong AY, Russo J, Labinaz M, Dick A, Froeschl M, Glover C, Hibbert B, Marquis JF, MacDougall A, Kass M, Paddock V, Quraishi AUR, Chandrasekhar J, Ghosh N, Bernick J, Le May M. Acute kidney injury after radial or femoral artery access in ST-segment elevation myocardial infarction: AKI-SAFARI. Am Heart J. 2021 Apr;234:12-22. doi: 10.1016/j.ahj.2020.12.019. Epub 2021 Jan 7.

    PMID: 33422518DERIVED

  • Le May M, Wells G, So D, Chong AY, Dick A, Froeschl M, Glover C, Hibbert B, Marquis JF, Blondeau M, Osborne C, MacDougall A, Kass M, Paddock V, Quraishi A, Labinaz M. Safety and Efficacy of Femoral Access vs Radial Access in ST-Segment Elevation Myocardial Infarction: The SAFARI-STEMI Randomized Clinical Trial. JAMA Cardiol. 2020 Feb 1;5(2):126-134. doi: 10.1001/jamacardio.2019.4852.

    PMID: 31895439DERIVED

MeSH Terms

Conditions

Myocardial InfarctionST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Michel R Le May, MD

    Ottawa Heart Institute Research Corporation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Regional ACS Programs

Study Record Dates

First Submitted

July 13, 2011

First Posted

July 20, 2011

Study Start

July 1, 2011

Primary Completion

December 1, 2018

Study Completion

January 16, 2019

Last Updated

January 29, 2019

Record last verified: 2019-01

Locations

CA(5)