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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 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: August 20, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Myocardial Infarction
Procedure: Radial access site vs. Femoral Access site

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: The Safety and Efficacy of Femoral Access Versus Radial for Primary Percutaneous Coronary Intervention in ST-Elevation Myocardial Infarction (SAFARI-STEMI Trial)

Resource links provided by NLM:


Further study details as provided by University of Ottawa Heart Institute:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 2770
Study Start Date: July 2011
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Transradial Access 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.
Transfemoral Access 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01398254

Contacts
Contact: Michel R Le May, MD 613-761-4223 mlemay@ottawaheart.ca
Contact: Melissa Blondeau 613-798-5555 ext 18948 mblondeau@ottawaheart.ca

Locations
Canada, Manitoba
St. Boniface Hospital Recruiting
Winnipeg, Manitoba, Canada, R2H 2A6
Contact: Malek Kass    204-258-1266      
Contact: Dolores Friesen    204-258-1142    dfriesen8@sbgh.mb.ca   
Principal Investigator: Malek Kass, MD         
Canada, New Brunswick
Saint John Regional Hospital Recruiting
Saint John, New Brunswick, Canada, E2L 4L2
Contact: Vernon Paddock    506-648-6101    vernon.paddock@horizonnb.ca   
Contact: Elizabeth Collings       elizabeth.collings@horizonnb.ca   
Principal Investigator: Vernon Paddock, MD         
Canada, Nova Scotia
Queen Elizabeth II Health Sciences Center Recruiting
Halifax, Nova Scotia, Canada, B3H 4G4
Contact: Ata-ur-Rehman Quraishi    902-473-8223    ata.quraishi@cdha.nshealth.ca   
Contact: Nancy Fitzgerald    902-473-7417    nancy.fitzgerald@cdha.nshealth.ca   
Principal Investigator: Ata-Ur-Rehman Quraishi, MD         
Canada, Ontario
University of Ottawa Heart Institute Recruiting
Ottawa, Ontario, Canada, K1Y 4W7
Contact: Michel R Le May, MD    613-761-4223    mlemay@ottawaheart.ca   
Contact: Melissa Blondeau    613-798-5555 ext 18948    mblondeau@ottawaheart.ca   
Principal Investigator: Michel Le May, MD         
Thunder Bay Regional Health Sciences Center Not yet recruiting
Thunder Bay, Ontario, Canada, P7B 6V4
Contact: Andrea MacDougall, MD         
Principal Investigator: Andrea MacDougall, MD         
Sponsors and Collaborators
University of Ottawa Heart Institute
Investigators
Principal Investigator: Michel R Le May, MD University of Ottawa Heart Institute
  More Information

No publications provided

Responsible Party: Michel Le May, Director of Coronary Care Unit, University of Ottawa Heart Institute
ClinicalTrials.gov Identifier: NCT01398254     History of Changes
Other Study ID Numbers: MRL-SS, 2011311-01H
Study First Received: July 13, 2011
Last Updated: August 20, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Ottawa Heart Institute:
ST-Elevation Myocardial Infarction

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on August 28, 2014