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

NCT03804125 | Withdrawn

• 2 other identifiers: B0661097ELICUIS FV MEXICO
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Cerebral Stroke; Thrombosis, Deep Vein; Pulmonary Embolism

Outcome Measures

Primary Outcomes (1)

• the number and type of suspected adverse drug reactions, including serious and non-serious cases

  To characterize and to analyze the number, type and incidence of suspected adverse drug reaction (SADRs) in patients receiving apixaban according to the therapeutic indications approved in Mexico: A. Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more risk factors as prior stoke or transient ischaemic attack; age \>75; hypertension; diabetes mellitus; symptomatic heart failure (NYHA class \>II) B. and in prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip or knee replacement surgery

  48 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients who have received at least one dose of apixaban for prevention stroke and systemic embolism with non-valvular atrial fibrillation or for prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip or knee replacement surgery

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

MeSH Terms

Conditions

Stroke; Venous Thrombosis; Pulmonary Embolism

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Thrombosis; Embolism and Thrombosis; Lung Diseases; Respiratory Tract Diseases; Embolism

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 48 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2019
• First Posted: January 15, 2019
• Study Start: September 1, 2021
• Primary Completion: June 30, 2023
• Study Completion: March 1, 2024
• Last Updated: November 22, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share