A Study of Adverse Events and Suspected Adverse Drug Reactions in Patients Under Apixaban for Pre… (NCT03804125) | Clinical Trial Compass
WithdrawnNot Applicable
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
Stopped: Company decision to not conduct the study and was cancelled prior to any enrollment.
0Started 2021-09-01
Plain-language summary
To characterize and analyze the number, type and incidence of adverse events/suspected adverse drug reactions in patients treated with Apixaban, according to therapeutic indications approved in Mexico.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* 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:
* 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 surger…
What they're measuring
1
the number and type of suspected adverse drug reactions, including serious and non-serious cases