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Femoral Versus Radial Access for Primary PCI (SAFARI-STEMI)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2016 by Ottawa Heart Institute Research Corporation
Sponsor:
Information provided by (Responsible Party):
Michel Le May, Ottawa Heart Institute Research Corporation
ClinicalTrials.gov Identifier:
NCT01398254
First received: July 13, 2011
Last updated: April 12, 2016
Last verified: April 2016

July 13, 2011
April 12, 2016
July 2011
August 2019   (final data collection date for primary outcome measure)
All-cause mortality [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
The primary outcomes will be all-cause mortality measured at 30 days.
Safety and Efficacy [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
The primary objective is to assess the safety and efficacy of transradial (TRA) in comparison to transfemoral (TFA) in patients presenting with STEMI who are referred for Primary PCI. The primary clinical safety endpoint will be to determine if the TRA approach is associated with fewer bleeding events as compared to the traditional approach using TFA. The primary clinical efficacy endpoint is to determine if TRA is not inferior to TFA by comparing the difference in the PCI center door-to-balloon time interval between the two groups.
Complete list of historical versions of study NCT01398254 on ClinicalTrials.gov Archive Site
  • Death, reinfarction, or stroke [ Time Frame: 30 days and 6 months ] [ Designated as safety issue: Yes ]
  • All-cause mortality [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Reinfarction [ Time Frame: 30 days and 6 months ] [ Designated as safety issue: Yes ]
  • Stroke [ Time Frame: 30 days and 6 months ] [ Designated as safety issue: Yes ]
  • Stent thrombosis [ Time Frame: 30 days and 6 months ] [ Designated as safety issue: Yes ]
  • Bleeding [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Number of blood transfusions [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Cardiogenic shock [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Critical time intervals (including door-to-balloon time) [ Time Frame: Index hospitalization ] [ Designated as safety issue: Yes ]
  • Fluoroscopy time and radiation exposure [ Time Frame: Index Catheterization ] [ Designated as safety issue: Yes ]
  • Length of Hospital Stay [ Time Frame: Index hospitalization ] [ Designated as safety issue: No ]
  • Resource utilization [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Death [ Time Frame: 30 days and 6 months ] [ Designated as safety issue: No ]
  • Reinfarction [ Time Frame: 30 days and 6 months ] [ Designated as safety issue: No ]
  • Stroke [ Time Frame: 30 days and 6 months ] [ Designated as safety issue: No ]
  • Composite of Death, Reinfarction and Stroke [ Time Frame: 30 days and 6 months ] [ Designated as safety issue: No ]
  • Abrupt vessel closure [ Time Frame: 30 days and 6 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Femoral Versus Radial Access for Primary PCI
The Safety and Efficacy of Femoral Access Versus Radial for Primary Percutaneous Coronary Intervention in ST-Elevation Myocardial Infarction (SAFARI-STEMI Trial)

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Myocardial Infarction
  • STEMI
Procedure: Primary Percutaneous Coronary Intervention (PPCI)
Participants will be randomly assigned an access site, radial or femoral, for PPCI.
  • TRA
    Transradial Access
    Intervention: Procedure: Primary Percutaneous Coronary Intervention (PPCI)
  • TFA
    Transfemoral Access
    Intervention: Procedure: Primary Percutaneous Coronary Intervention (PPCI)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
4884
April 2020
August 2019   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Ischemic chest discomfort of greater or equal to 30 minutes duration,
  2. Onset of chest pain of greater or equal to 12 hrs prior to entry into the study,
  3. 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

Exclusion Criteria:

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

    • Bivalirudin is contraindicated in renal failure.
Both
18 Years and older   (Adult, Senior)
No
Contact: Michel R Le May, MD 613-761-4223 mlemay@ottawaheart.ca
Contact: Melissa Blondeau 613-798-5555 ext 18948 mblondeau@ottawaheart.ca
Canada
 
NCT01398254
MRL-SS, 2011311-01H
Yes
Not Provided
Not Provided
Michel Le May, Ottawa Heart Institute Research Corporation
Ottawa Heart Institute Research Corporation
Not Provided
Principal Investigator: Michel R Le May, MD Ottawa Heart Institute Research Corporation
Ottawa Heart Institute Research Corporation
April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP