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A Study of Adverse Events and Suspected Adverse Drug Reactions in Patients Under Apixaban for Prevention of Stroke and Systemic Embolism With Non-Valvular Atrial Fibrillation and Venous Thromboembolic Events in Patients Who Have Undergone Elective Hip or Knee Replacement Surgery

Last updated on March 15, 2019

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Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Cerebral Stroke, Deep Vein Thrombosis, Pulmonary Embolism
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- A 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.

- Patients (men and women) over 18 years old.

- Patients who have received at least one dose of apixaban for prevention of stroke and
systemic embolism with non-valvular atrial fibrillation with one or more of the
following stroke risk factors: prior stoke or transient ischaemic attack; age >75;
hypertension; diabetes mellitus; symptomatic heart failure (NYHA class >II); or for
prevention of venous thromboembolic events (VTE) in adult patients who have undergone
elective hip or knee replacement surgery.

- Subjects who are willing and able to comply with all scheduled visits.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Patients who have received apixaban in a clinical trial.

- Patients who received apixaban for another indication locally approved or have a
contraindication according to the information to prescribe of the product in Mexico.

- Hypersensitivity to the active substance or to any of the excipients.

- Active clinically significant bleeding.

- Hepatic disease associated with coagulopathy and clinically relevant bleeding risk.

- Lesion or condition 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 haemorrhage, known or suspected oesophageal
varices, arteriovenous malformations, vascular aneurysms or major intraspinal or
intracerebral vascular abnormalities.

- 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, rivaroxaban,
dabigatran, etc.) except under specific circumstances of switching anticoagulant
therapy. Concomitant medication with Nonsteroidal anti-inflammatory drugs (NSAIDs ).

- Pregnancy and breast-feeding.

- Severe acute or chronic psychiatric condition and other significant medical condition.

NCT03804125
Pfizer
Not yet recruiting
A Study of Adverse Events and Suspected Adverse Drug Reactions in Patients Under Apixaban for Prevention of Stroke and Systemic Embolism With Non-Valvular Atrial Fibrillation and Venous Thromboembolic Events in Patients Who Have Undergone Elective Hip or Knee Replacement Surgery

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Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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