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SAFE-PCI for Women

This study has been terminated.
(Study stopped for Statistical Futility. Low rate of bleeding events made it unlikely there would be statistical power to show a difference in the 2 arms.)
Sponsor:
Collaborators:
American College of Cardiology Foundation
Abbott Vascular
Lilly USA
Medtronic
Terumo Medical Corporation
The Medicines Company
Acist Medical Systems
Guerbet
FDA - Office of Women's Health
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01406236
First received: June 20, 2011
Last updated: January 16, 2015
Last verified: January 2015
History of Changes
  Purpose

The hypothesis of the SAFE-PCI for women trial is that, compared with transfemoral PCI, transradial PCI will result in a significant reduction in bleeding and vascular complications. The primary objective is to compare the efficacy and feasibility of the transradial approach to percutaneous coronary intervention (PCI) in women compared with the transfemoral approach.

This study is a multicenter, randomized, open-label active controlled study. Three thousand women undergoing urgent or elective PCI from at least 50 centers will be randomized to either transradial or transfemoral PCI. Patients who are enrolled at sites performing ad hoc PCI will be randomized before diagnostic angiography. A total of approximately 3000 women will be randomized to obtain a cohort of approximately 1800 patients undergoing PCI.

The Data Safety Monitoring Board has alerted us that the bleeding event rate overall in our trial is very low, making it unlikely that there will be statistical power to show a difference between the randomized arms in the SAFE PCI for Women study using the BARC bleeding definition per protocol. Based on this statistical futility, the DSMB has recommended stopping enrollment. They also noted, however, that as this is not based on any safety issues, and since there are a variety of key secondary endpoints (contrast and radiation exposure, quality of life) that are of clinical and scientific interest, the DSMB left it to the discretion of the Steering Committee to continue enrollment to meet sufficient power for these outcomes. On March 1, 2013, the Steering Committee met to discuss these issues and voted to continue enrollment until the planned sample size for the Quality of Life substudy was met (300 patients).


Condition Intervention
Percutaneous Coronary Intervention
Ischemic Symptoms
 Procedure: Transradial PCI
Procedure: Transfemoral PCI

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study of Access Site for Enhancement of PCI for Women (SAFE-PCI for Women)

Further study details as provided by Duke University:

Primary Outcome Measures:
  • Primary Efficacy Endpoint: Composite of BARC Types 2, 3, and 5 bleeding or vascular complications. [ Time Frame: From first arterial access post-randomization to 72 hours or hospital discharge, whichever occurs first. ] [ Designated as safety issue: Yes ]
  • Primary Feasibility Endpoint: Procedural failure, defined as inability to complete the procedure from the assigned vascular access site. [ Time Frame: From first arterial access post-randomization to 72 hours or hospital discharge, whichever occurs first. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Procedure Duration, total radiation dose and total contrast volume [ Time Frame: 72 hours post randomization or hospital discharge (whichever occurs first) ] [ Designated as safety issue: No ]
    To determine the effect of transradial PCI on procedure time, total radiation dose, and total contrast volume.

  • Resource Use, patient preferences and quality of life [ Time Frame: Baseline, 72 hours post randomization or hospital discharge (whichever occurs first), 30 day ] [ Designated as safety issue: No ]
    To determine the effect of transradial PCI on resource use, patient preferences, and quality of life.

  • 30-day death, vascular complications, or repeat revascularization [ Time Frame: 30 day ] [ Designated as safety issue: Yes ]
    To determine the effect of transradial PCI on 30-day death, vascular complications, or repeat revascularization.
Enrollment: 1787
Study Start Date: August 2011
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Transradial PCI Procedure: Transradial PCI
Transradial PCI
Transfemoral PCI Procedure: Transfemoral PCI
Transfemoral PCI

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

Inclusion Criteria:

  • Have the capacity to understand and sign an informed consent form
  • Age ≥ 18 years
  • Female patient undergoing urgent or elective PCI or undergoing diagnostic angiography to evaluate ischemic symptoms with the possibility of PCI

Exclusion Criteria:

  • Peripheral arterial disease that prohibits vascular access
  • Bilateral abnormal Barbeau tests
  • Hemodialysis access (arteriovenous fistula or graft) in the arm to be used for PCI in case of assignment to radial approach (note that the opposite arm may be used for radial access in case a dialysis graft is present in one arm provided that the opposite arm has a normal Barbeau test)
  • International normalized ratio (INR) ≥ 1.5 in a patient treated with oral vitamin K antagonists (i.e., warfarin).
  • Receipt of oral Factor Xa or IIa inhibitors ≤ 24 hours prior to the procedure
  • Planned staged PCI within 30 days of index procedure
  • Valvular heart disease requiring valve surgery
  • Planned right-heart catheterization
  • Primary PCI for ST-segment elevation myocardial infarction
  • Presence of bilateral internal mammary artery coronary bypass grafts
  • Unable to provide informed consent
  • Participation in any investigational drug or device study currently or within 30 days prior to enrollment
  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: NCT01406236

Sponsors and Collaborators
Duke University
American College of Cardiology Foundation
Abbott Vascular
Lilly USA
Medtronic
Terumo Medical Corporation
The Medicines Company
Acist Medical Systems
Guerbet
FDA - Office of Women's Health
Investigators
Principal Investigator: Sunil V Rao, MD Duke University
  More Information

No publications provided by Duke University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01406236     History of Changes
Other Study ID Numbers: Pro00030109
Study First Received: June 20, 2011
Last Updated: January 16, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
Female
urgent or elective percutaneous coronary intervention
PCI
diagnostic angiography

ClinicalTrials.gov processed this record on March 03, 2015