SAFE-PCI for Women (SAFE-PCI)
|ClinicalTrials.gov Identifier: NCT01406236|
Recruitment Status : 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.)
First Posted : August 1, 2011
Last Update Posted : January 21, 2015
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 or disease||Intervention/treatment||Phase|
|Percutaneous Coronary Intervention Ischemic Symptoms||Procedure: Transradial PCI Procedure: Transfemoral PCI||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1787 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Study of Access Site for Enhancement of PCI for Women (SAFE-PCI for Women)|
|Study Start Date :||August 2011|
|Actual Primary Completion Date :||September 2013|
|Actual Study Completion Date :||September 2013|
Procedure: Transradial PCI
Procedure: Transfemoral PCI
- 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. ]
- 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. ]
- Procedure Duration, total radiation dose and total contrast volume [ Time Frame: 72 hours post randomization or hospital discharge (whichever occurs first) ]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 ]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 ]To determine the effect of transradial PCI on 30-day death, vascular complications, or repeat revascularization.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01406236
|Principal Investigator:||Sunil V Rao, MD||Duke University|