Cerebral StrokeNCT03804125
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
An observational study of Cerebral Stroke and Thrombosis, Deep Vein, run by Pfizer.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebral Stroke, Thrombosis, Deep Vein, Pulmonary Embolism
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2021to 1 Mar 2024
- How long will I take part?
- 48 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
About this study
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)
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
- Medical subject headings
- Stroke, Venous Thrombosis, Pulmonary Embolism
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- 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
Measured: 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2019
- Study start1 Sep 2021 (estimated)
- Primary completion30 Jun 2023 (estimated)
- Study completion1 Mar 2024 (estimated)
Why it stopped: Company decision to not conduct the study and was cancelled prior to any enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral StrokeStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
- Target duration
- 48 Months
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03804125
- Sponsor's protocol ID
- B0661097
- Other IDs
- ELICUIS FV MEXICO
- Status last verified
- Nov 2021
- First submitted
- 11 Jan 2019
- Last updated
- 22 Nov 2021
- Results posted
- No
- Individual data sharing
- No: 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/data\_requests.
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03804125
- Acronym / sponsor ID
- B0661097
- Conditions
- Cerebral Stroke, Thrombosis, Deep Vein, Pulmonary Embolism
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Company decision to not conduct the study and was cancelled prior to any enrollment.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2021 (estimated)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 15 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 48 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
the number and type of suspected adverse drug reactions, including serious and non-serious cases
Time frame: 48 months
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2021.
- Individual participant dataSharing planned: No. 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/data_requests.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Stroke and Thrombosis, Deep Vein, run by Pfizer.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 22 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the number and type of suspected adverse drug reactions, including serious and non-serious cases (time frame: 48 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2021.