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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by University of Ottawa Heart Institute
Sponsor:
Information provided by (Responsible Party):
Michel Le May, University of Ottawa Heart Institute
ClinicalTrials.gov Identifier:
NCT01398254
First received: July 13, 2011
Last updated: January 13, 2014
Last verified: January 2014

July 13, 2011
January 13, 2014
July 2011
December 2016   (final data collection date for primary outcome measure)
NACE [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
Safety and efficacy will be measured by the rate of Net Adverse Clinical Events (NACE) defined as a composite of death, reinfarction, stroke, or TIMI (major or minor) bleeding.
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
Not Provided
  • 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)

Patients with ST-elevation myocardial infarction (STEMI) presenting with ischemic chest discomfort for greater or equal to 30 minutes, and onset of chest pain greater or equal to 12 hrs on presentation will be enrolled into the study. Eligible patients will be randomized to Transradial access (TRA) or to Transfemoral access (TFA). All patients will receive bivalirudin as anticoagulant for PCI.

Procedural outcomes will be compared between groups. During hospitalization, and follow-up visits, patients will be followed for safety, adverse events and clinical outcomes. Follow-up visits will occur at 1-2 weeks by telephone, 30 days, and 6 months by clinic visits, at which time patients will be interviewed regarding the occurrence of clinical endpoints and adverse events. The primary safety endpoint will be the rate of major bleeding event defined as TIMI major or minor measured at 30 days. The primary efficacy endpoint is the PCI center door-to-balloon time interval.

Rationale for the Trial: Bleeding complicating interventional procedures is now considered a predictor of ischemic events, including death. Many studies conclude that bleeding complications at the access site occur less frequently with PCI when transradial access (TRA) rather than transfemoral access (TFA) is used. However, there is limited data in the STEMI literature comparing the two approaches. In North America less than 2% of operators have switched to TRA as the standard approach for primary PCI. Concern has been expressed that TRA is associated with longer door-to-balloon times which is also associated with increased mortality. In addition, recent studies indicate that the direct thrombin inhibitor bivalirudin is associated with reduced bleeding and improved survival in patients treated with primary PCI.

No large randomized trial designed to evaluate bleeding outcomes in patients referred for primary PCI assigned to TRA or TFA has yet to be published and no trial has been designed which includes bivalirudin as the routine anticoagulant used for the procedure.

Therefore, the investigators have designed a trial to address specifically the bleeding differences between TRA and TFA using the direct thrombin inhibitor bivalirudin in the two groups. If TRA is shown to be safer, this may influence interventional cardiologists at changing practice for primary PCI.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Myocardial Infarction
Procedure: Radial access site vs. Femoral Access site
Comparison of different access site for primary percutaneous coronary intervention:radial access site versus femoral access site.
  • Transradial Access
    Intervention: Procedure: Radial access site vs. Femoral Access site
  • Transfemoral Access
    Intervention: Procedure: Radial access site vs. Femoral Access site
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
2770
June 2017
December 2016   (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, clopidogrel,prasugrel, and ticagrelor
  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
Both
18 Years and older
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
Michel Le May, University of Ottawa Heart Institute
University of Ottawa Heart Institute
Not Provided
Principal Investigator: Michel R Le May, MD University of Ottawa Heart Institute
University of Ottawa Heart Institute
January 2014

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