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

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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.
Show details

- 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.
Show details


- 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.

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Descriptive Information
Brief Title 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
Official Title A PHASE IV NON-INTERVENTIONAL STUDY. ADVERSE EVENTS (AES)/SUSPECTED ADVERSE DRUG REACTIONS (SADRS) ON THE 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) AND PREVENTION OF VENOUS THROMBOEMBOLIC EVENTS (VTE) IN ADULT PATIENTS WHO HAVE UNDERGONE ELECTIVE HIP OR KNEE REPLACEMENT SURGERY UNDER TREATMENT WITH ELICUIS (REGISTERED) (APIXABAN)
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.
Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration 48 Months
Biospecimen Not Provided
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
Condition
  • Cerebral Stroke
  • Thrombosis, Deep Vein
  • Pulmonary Embolism
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
 (submitted: January 11, 2019)
200
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 29, 2023
Estimated Primary Completion Date June 30, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria

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 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.
Sex/Gender
Sexes Eligible for Study:All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03804125
Other Study ID Numbers B0661097
ELICUIS FV MEXICO ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD:No
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date May 2020