News | Antiplatelet and Anticoagulation Therapies | December 17, 2015

ROCKET AF Clinical Trial Executive Committee Releases Secondary Analysis

Findings reveal trial outcomes were not impacted by malfunctioning monitors recalled by FDA

ROCKET AF, executive committee, secondary analysis, rivaroxaban, FDA recall

December 17, 2015 — The ROCKET AF Clinical Trial Executive Committee announced its secondary analysis of the phase III trial (ROCKET AF) of the oral anticoagulant rivaroxaban. The analysis was prompted by a December 2014 U.S. Food and Drug Administration (FDA) recall of a device used in the study.

From 2006 to 2010, the ROCKET AF trial studied rivaroxaban as compared with warfarin for the prevention of stroke and systemic embolism in patients with atrial fibrillation and at increased risk for stroke. Following completion of the trial and rivaroxaban's initial FDA approval in 2011, the FDA issued a recall of the Alere INRatio and INRatio2 PT/INR Monitor system used in the trial to measure INR blood clotting levels for certain patient populations.

In order to understand the effect the possible malfunctioning of the device might have had in specific patient groups, the ROCKET AF Executive Committee and the Duke Clinical Research Institute conducted a secondary analysis of the trial findings.

The findings from the analysis are consistent with the results from the original trial and do not alter the conclusions of ROCKET AF—rivaroxaban is a reasonable alternative to warfarin and is non-inferior for the prevention of stroke and systemic embolism with less intracranial hemorrhage and fatal bleeding.

The ROCKET AF Executive Committee intends to publish a full description of this analysis and results as rapidly as possible.

This news may raise questions from patients who are currently prescribed rivaroxaban. It is important to recognize that there are risks with abruptly stopping any anticoagulant. Patients should discuss any questions with their physician.

For more information: www.dcri.org

Related Content

Xarelto Reduces Ischemic Stroke for Coronary and Peripheral Artery Disease Patients
News | Antiplatelet and Anticoagulation Therapies | February 19, 2018
A late-breaking analysis of the landmark COMPASS study was presented at the 2018 International Stroke Conference (ISC...
Abbott Begins Enrollment in XIENCE 28 GLOBAL DAPT Trial
News | Antiplatelet and Anticoagulation Therapies | February 13, 2018
Abbott announced the first patient has been enrolled in a clinical trial evaluating 28 days of dual antiplatelet...
Baxter Announces FDA Approval of Ready-to-Use Cardiovascular Medication Bivalirudin
Technology | Antiplatelet and Anticoagulation Therapies | January 22, 2018
January 22, 2018 — Baxter International Inc. announced the U.S.
News | Antiplatelet and Anticoagulation Therapies | January 19, 2018
The U.S. Food and Drug Administration (FDA) announced that International Laboratories LLC is voluntarily recalling Lot...
New Oral Anticoagulant Drugs Associated with Lower Kidney Risks
News | Antiplatelet and Anticoagulation Therapies | December 12, 2017
Mayo Clinic researchers have shown a link between which type of oral anticoagulant a patient takes to prevent a stroke...
News | Antiplatelet and Anticoagulation Therapies | November 16, 2017
Bristol-Myers Squibb Company and Pfizer Inc. released real-world data (RWD) of outcomes associated with direct oral...
Six Months of DAPT Non-Inferior to Twelve in STEMI Patients Receiving Drug-Eluting Stents
News | Antiplatelet and Anticoagulation Therapies | November 06, 2017
November 6, 2017 —  The first trial to evaluate the safety of...
Statins Attributed With 10-Year Cholesterol Drop for Malaysian Heart Attack Patients
News | Antiplatelet and Anticoagulation Therapies | November 03, 2017
November 3, 2017 — A ten-year decline in the blood cholesterol of heart attack patients in Malaysia suggests...
COMPASS Trial Shows Rivaroxaban With Aspirin Improves Stable Cardiovascular Disease
Feature | Antiplatelet and Anticoagulation Therapies | September 12, 2017
September 12, 2017 — Rivaroxaban plus aspirin improves survival and reduces stroke and heart attack in patients with
Real-World Analysis Compares Safety, Effectiveness of Apixaban Versus Warfarin
News | Antiplatelet and Anticoagulation Therapies | August 28, 2017
August 28, 2017 — Bristol-Myers Squibb Company and Pfizer Inc.
Overlay Init