SAFE-PCI for Women (SAFE-PCI)

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

Abbott Vascular

Lilly USA

Medtronic

Terumo Medical Corporation

The Medicines Company

Acist Medical Systems

Guerbet

Food and Drug Administration (FDA)

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 (Adult, Senior)
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

Abbott Vascular

Lilly USA

Medtronic

Terumo Medical Corporation

The Medicines Company

Acist Medical Systems

Guerbet

Food and Drug Administration (FDA)

Investigators


Principal Investigator:	Sunil V Rao, MD	Duke University

More Information

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

Rao SV, Hess CN, Barham B, Aberle LH, Anstrom KJ, Patel TB, Jorgensen JP, Mazzaferri EL Jr, Jolly SS, Jacobs A, Newby LK, Gibson CM, Kong DF, Mehran R, Waksman R, Gilchrist IC, McCourt BJ, Messenger JC, Peterson ED, Harrington RA, Krucoff MW. A registry-based randomized trial comparing radial and femoral approaches in women undergoing percutaneous coronary intervention: the SAFE-PCI for Women (Study of Access Site for Enhancement of PCI for Women) trial. JACC Cardiovasc Interv. 2014 Aug;7(8):857-67. doi: 10.1016/j.jcin.2014.04.007.

Hess CN, Rao SV, Kong DF, Aberle LH, Anstrom KJ, Gibson CM, Gilchrist IC, Jacobs AK, Jolly SS, Mehran R, Messenger JC, Newby LK, Waksman R, Krucoff MW. Embedding a randomized clinical trial into an ongoing registry infrastructure: unique opportunities for efficiency in design of the Study of Access site For Enhancement of Percutaneous Coronary Intervention for Women (SAFE-PCI for Women). Am Heart J. 2013 Sep;166(3):421-8. doi: 10.1016/j.ahj.2013.06.013. Epub 2013 Jul 23.


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 September 26, 2016

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