Reduced-dosed Rivaroxaban in the Long-term Prevention of Recurrent Symptomatic VTE(Venous Thromboembolism) (EinsteinChoice)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT02064439 |
|
Recruitment Status :
Completed
First Posted : February 17, 2014
Results First Posted : December 19, 2017
Last Update Posted : December 19, 2017
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
This is a multicenter, randomized, double-blind, event-driven, superiority study for efficacy.
Patients with confirmed symptomatic DVT (Deep Vein Thrombosis) or PE (Pulmonary embolism) who completed 6 or 12 months of treatment of anticoagulation are eligible for this trial
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Pulmonary Embolism Thromboembolism Thrombosis Venous Thrombosis Venous Thromboembolism | Drug: BAY 59-7939 Drug: ASA | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 3365 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Prevention |
| Official Title: | Reduced-dosed Rivaroxaban and Standard-dosed Rivaroxaban Versus ASA in the Long-term Prevention of Recurrent Symptomatic Venous Thromboembolism in Patients With Symptomatic Deep-vein Thrombosis and/or Pulmonary Embolism |
| Actual Study Start Date : | March 5, 2014 |
| Actual Primary Completion Date : | September 22, 2016 |
| Actual Study Completion Date : | November 4, 2016 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Arm 1
Rivaroxaban 10 mg once daily for 12 months
|
Drug: BAY 59-7939
10 mg tablet once daily for 12 months |
|
Experimental: Arm 2
Rivaroxaban 20 mg once daily for 12 months
|
Drug: BAY 59-7939
20 mg tablet once daily for 12 months |
|
Active Comparator: Arm 3
ASA (Acetylsalicylic Acid) 100 mg once daily for 12 months
|
Drug: ASA
100 mg tablet once daily for 12 months |
- Number of Participants With the Composite of Fatal or Non-fatal Symptomatic Recurrent Venous Thromboembolism [ Time Frame: Up to 12 months, at least 6 months ]
The primary efficacy outcomes (i.e., recurrent venous thromboembolism [VTE] defined as composite of fatal or non-fatal symptomatic recurrent VTE, including unexplained death for which pulmonary embolism [PE] could not be ruled out) as confirmed by the central independent adjudication committee (CIAC) were considered up to the end of the individual intended duration of treatment.
Incidence of the composite of the primary and secondary efficacy outcome and its components are based on the first occurrence to participant.
- Number of Participants With First Treatment-emergent Major Bleeding [ Time Frame: Up to 12 months, at least 6 months ]
The principal safety outcome was major bleeding which was defined according to the criteria of the International Society on Thrombosis and Hemostasis (ISTH) as clinically overt bleeding and associated with a fall in hemoglobin of 2 gram per deciliter (g/dL) or more, or leading to a transfusion of 2 or more units of packed red blood cells or whole blood, or occurring in a critical site, e.g. intracranial, intraspinal, intraocular, pericardial, intra articular, intramuscular with compartment syndrome, retroperitoneal, or contributing to death.
Incidence of the composite of the primary and secondary efficacy outcome and its components are based on the first occurrence to participant.
- Number of Participants With the Composite of the Primary Efficacy Outcome, Myocardial Infarction, Ischemic Stroke or Systemic Non-CNS Embolism [ Time Frame: Up to 12 months, at least 6 months ]The secondary efficacy outcome is the composite of the primary efficacy outcome, myocardial infarction (MI), ischemic stroke or non-central nervous system (CNS) systemic embolism. Incidence of the composite of the primary and secondary efficacy outcome and its components are based on the first occurrence to participant.
- Number of Participants With Non-major Bleeding Associated With Study Drug Interruption for > 14 Days [ Time Frame: Up to 12 months, at least 6 months ]The secondary safety outcome was clinically relevant non-major (CRNM) bleeding, which was adjudicated by the CIAC using the ASA criteria: the bleeding was non-major and the bleeding was associated with a study medication interruption of more than 14 days.
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, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients with confirmed symptomatic PE and/or DVT who have been treated for 6 to 12 months and did not interrupt anticoagulation for longer than 1 week
Exclusion Criteria:
- Legal lower age limitations (country specific) Indication for therapeutic-dosed anticoagulants Indication for antiplatelet therapy or a conventional non-steroid anti-inflammatory drug (NSAID) Hepatic disease which is associated with coagulopathy leading to a clinically relevant bleeding risk Calculated creatinine clearance < 30 mL/min
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02064439
Show 267 study locations
| Study Director: | Bayer Study Director | Bayer |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Bayer |
| ClinicalTrials.gov Identifier: | NCT02064439 |
| Other Study ID Numbers: |
16416 2013-000619-26 ( EudraCT Number ) |
| First Posted: | February 17, 2014 Key Record Dates |
| Results First Posted: | December 19, 2017 |
| Last Update Posted: | December 19, 2017 |
| Last Verified: | November 2017 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
|
deep vein thrombosis pulmonary embolism long-term prevention of recurrent symptomatic VTE |
|
Pulmonary Embolism Thrombosis Embolism Thromboembolism Venous Thromboembolism Venous Thrombosis Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases Lung Diseases |
Respiratory Tract Diseases Rivaroxaban Factor Xa Inhibitors Antithrombins Serine Proteinase Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anticoagulants |