Trial record 1 of 1 for:
nct02329327
A Study in Patients With Acute Major Bleeding to Evaluate the Ability of Andexanet Alfa to Reverse the Anticoagulation Effect of Direct and Indirect Oral Anticoagulants
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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT02329327 |
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Recruitment Status :
Recruiting
First Posted : December 31, 2014
Last Update Posted : May 16, 2018
|
Sponsor:
Portola Pharmaceuticals
Collaborator:
Population Health Research Institute
Information provided by (Responsible Party):
Portola Pharmaceuticals
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Brief Summary:
The purpose of this study is to evaluate the hemostatic efficacy of andexanet alfa in patients receiving a factor Xa inhibitor who are experiencing an acute major bleed. The safety of andexanet will also be studied.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Bleeding | Biological: Andexanet | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 350 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Other |
| Official Title: | Prospective, Open-Label Study of Andexanet Alfa in Patients Receiving a Factor Xa Inhibitor Who Have Acute Major Bleeding (ANNEXA-4) |
| Study Start Date : | January 2015 |
| Estimated Primary Completion Date : | November 2022 |
| Estimated Study Completion Date : | November 2022 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
| Experimental: Single Arm |
Biological: Andexanet |
Primary Outcome Measures :
- Proportion of patients with excellent or good hemostasis [ Time Frame: Stopping major bleed at 12 hours from the start of andexanet bolus ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion:
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Acute major bleeding episode requiring urgent reversal of anticoagulation; defined by at least one of the following:
- Acute bleeding that is potentially life-threatening, OR
- Acute bleeding associated with a fall in hemoglobin level by ≥2 g/dL, OR
- Acute bleeding associated with a hemoglobin level of ≤8 g/dL if no baseline hemoglobin is available, OR
- Acute bleeding in a critical area or organ such as intraspinal, pericardial, or intracranial.
- If bleeding is intracranial or intraspinal, the patient must have undergone a head CT or MRI scan demonstrating the bleeding.
- Patient received or is believed to have received one of the following within 18 hours prior to andexanet administration: apixaban, rivaroxaban, edoxaban or enoxaparin.
- For patients with intracranial bleeding, there must be a reasonable expectation that andexanet treatment will commence within 2 hours of the baseline imaging evaluation.
Exclusion:
- The patient is scheduled to undergo surgery in less than 12 hours, with the exception of minimally invasive surgery/procedures.
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A patient with an intracerebral hemorrhage has any of the following:
- Glasgow coma score < 7, OR
- Intracerebral hematoma > 60 cc as assessed by CT or MRI
- Patients with visible, musculoskeletal or intra-articular bleeding as their qualifying bleed.
- Expected survival of less than 1 month
- Recent history (within 2 weeks) of a diagnosed thrombotic event (TE) as follows: venous thromboembolism, myocardial infarction, disseminated intravascular coagulation (DIC), cerebral vascular accident, transient ischemic attack, unstable angina pectoris hospitalization or severe peripheral vascular disease within 2 weeks prior to screening.
- Severe sepsis or septic shock at the time of Screening.
- Pregnant or a lactating female.
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Patient has received any of the following drugs or blood products within 7 days of Screening:
- Vitamin K antagonist (VKA)
- Dabigatran
- Prothrombin Complex Concentrate products (PCC) or recombinant factor VIIa (rfVIIa)
- Whole blood, plasma fractions
- Treated with an investigational drug <30 days prior to Screening
- Planned administration of PCC, fresh frozen plasma (FFP) or rfVIIa from Screening until within 12 hours after the end of the andexanet infusion.
Information from the National Library of Medicine
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): NCT02329327
Contacts
| Contact: Patrick Yue, M.D. | 650.246.7000 | fXaantidote@portola.com |
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Locations
| United States, California | |
| Portola Investigational Site | Recruiting |
| Long Beach, California, United States | |
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| Los Angeles, California, United States | |
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| Orange, California, United States | |
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| United States, Florida | |
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| Fort Lauderdale, Florida, United States | |
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| Jacksonville, Florida, United States | |
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| Sarasota, Florida, United States | |
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| Tampa, Florida, United States | |
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| United States, Maryland | |
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| Annapolis, Maryland, United States | |
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| United States, Massachusetts | |
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| Boston, Massachusetts, United States | |
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| United States, Michigan | |
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| Detroit, Michigan, United States | |
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| Royal Oak, Michigan, United States | |
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| Troy, Michigan, United States | |
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| United States, Missouri | |
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| Saint Louis, Missouri, United States | |
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| United States, New York | |
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| Rochester, New York, United States | |
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| United States, North Carolina | |
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| Asheville, North Carolina, United States | |
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| Chapel Hill, North Carolina, United States | |
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| Tübingen, Germany | |
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| Ulm, Germany | |
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| Würzburg, Germany | |
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| Netherlands | |
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| Spain | |
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| Barcelona, Spain | |
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| Madrid, Spain | |
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| United Kingdom | |
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| Cardiff, United Kingdom | |
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| London, United Kingdom | |
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| Stoke on Trent, United Kingdom | |
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Sponsors and Collaborators
Portola Pharmaceuticals
Population Health Research Institute
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Portola Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT02329327 History of Changes |
| Other Study ID Numbers: |
14-505 |
| First Posted: | December 31, 2014 Key Record Dates |
| Last Update Posted: | May 16, 2018 |
| Last Verified: | May 2018 |
Keywords provided by Portola Pharmaceuticals:
|
Factor Xa Inhibitors Major Bleeding Anticoagulant |
Additional relevant MeSH terms:
|
Hemorrhage Pathologic Processes Anticoagulants Factor Xa Inhibitors Antithrombins |
Serine Proteinase Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |