A Study of Adverse Events and Suspected Adverse Drug Reactions of Patients Under Treatment of Apixaban for Venous Thomboembolism (VTE) Treatment
NCT03812835
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
Adult Trials: 18+ Years
Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:
1. Evidence a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
2. Patients (men and women) >18 years old.
3. Patients who have received at least one dose of apixaban for treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE); prevention of recurrent DVT and PE
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Patients meeting any of the following criteria will not be included in the study:
1. Patients who are participating in a clinical trial.
2. Hypersensitivity to the active substance or to any of the excipients.
3. Active clinically significant bleeding.
4. Hepatic disease associated with coagulopathy and clinically relevant bleeding risk,
based on hepatic function tests.
5. Lesion or condition if considered a significant risk factor for major bleeding. This
may include current or recent gastrointestinal ulceration, presence of malignant
neoplasms at high risk of bleeding, recent brain or spinal injury, recent brain,
spinal or ophthalmic surgery, recent intracranial hemorrhage, known or suspected
esophageal varices, arteriovenous malformations, vascular aneurysms or major
intraspinal or intracerebral vascular abnormalities.
6. Concomitant treatment with any other anticoagulant agent e.g. unfractionated heparin
(UFH), low molecular weight heparins (enoxaparin, dalteparin, etc.), heparin
derivatives (fondaparinux, etc.), and oral anticoagulants (warfarin, acenocoumarin,
rivaroxaban, dabigatran, etc.) except under specific circumstances of switching
anticoagulant therapy.
7. Pregnancy and breast-feeding.
8. Severe acute or chronic psychiatric condition and other significant medical condition.
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| Descriptive Information | |||||
|---|---|---|---|---|---|
| Brief Title | A Study of Adverse Events and Suspected Adverse Drug Reactions of Patients Under Treatment of Apixaban for Venous Thomboembolism (VTE) Treatment | ||||
| Official Title | A PHASE IV NON-INTERVENTIONAL STUDY. REGISTRY OF ADVERSE EVENTS (AES)/SUSPECTED ADVERSE DRUG REACTIONS (SADRS) OF ADULT PATIENTS UNDER TREATMENT OF DEEP VEIN THROMBOSIS (DVT) AND PULMONARY EMBOLISM (PE); PREVENTION OF RECURRENT DVT AND PE WITH ELICUIS REGISTERED (APIXABAN) | ||||
| Brief Summary | Number, type and incidence of adverse events/suspected adverse drug reactions in patients treated with apixaban, according to therapeutic indications approved in Mexico. | ||||
| Detailed Description | Not Provided | ||||
| Study Type | Observational | ||||
| Study Design | Observational Model: Other Time Perspective: Prospective | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Adult patients who have received at least one dose of apixaban for treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE); prevention of recurrent DVT and PE. | ||||
| Condition |
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| Intervention | Not Provided | ||||
| Study Groups/Cohorts | Not Provided | ||||
| Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||
| Recruitment Information | |||||
| Recruitment Status | Not yet recruiting | ||||
| Estimated Enrollment | 100 | ||||
| Original Estimated Enrollment | Same as current | ||||
| Estimated Study Completion Date | February 28, 2023 | ||||
| Estimated Primary Completion Date | August 30, 2022 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria | Inclusion Criteria: Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:
Exclusion Criteria: Patients meeting any of the following criteria will not be included in the study:
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts |
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| Listed Location Countries | Not Provided | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03812835 | ||||
| Other Study ID Numbers | B0661104 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| U.S. FDA-regulated Product | Not Provided | ||||
| IPD Sharing Statement |
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| Responsible Party | Pfizer | ||||
| Study Sponsor | Pfizer | ||||
| Collaborators | Not Provided | ||||
| Investigators |
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| PRS Account | Pfizer | ||||
| Verification Date | May 2020 | ||||