Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
1787 participants
INTERVENTIONAL
2011-08-31
2013-09-30
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Transradial PCI
Transradial PCI
Transradial PCI
Transfemoral PCI
Transfemoral PCI
Transfemoral PCI
Interventions
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Transradial PCI
Transradial PCI
Transfemoral PCI
Transfemoral PCI
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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American College of Cardiology
OTHER
Abbott Medical Devices
INDUSTRY
Lilly USA
UNKNOWN
Medtronic
INDUSTRY
Terumo Medical Corporation
INDUSTRY
The Medicines Company
INDUSTRY
Acist Medical Systems
INDUSTRY
Guerbet
INDUSTRY
Food and Drug Administration (FDA)
FED
Duke University
OTHER
Responsible Party
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Principal Investigators
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Sunil V Rao, MD
Role: PRINCIPAL_INVESTIGATOR
Duke University
References
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Rymer JA, Kaltenbach LA, Kochar A, Hess CN, Gilchrist IC, Messenger JC, Harrington RA, Jolly SS, Jacobs AK, Abbott JD, Wojdyla DM, Krucoff MW, Rao SV. Comparison of Rates of Bleeding and Vascular Complications Before, During, and After Trial Enrollment in the SAFE-PCI Trial for Women. Circ Cardiovasc Interv. 2019 May;12(5):e007086. doi: 10.1161/CIRCINTERVENTIONS.118.007086.
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.
Other Identifiers
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Pro00030109
Identifier Type: -
Identifier Source: org_study_id
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