Clinical trial NCT03812835: A Study of Adverse Events and Suspected Adverse Drug Reactions of Patients Under Treatment of Apixaban for Venous Thomboembolism (VTE) Treatment
Official title: A PHASE IV NON-INTERVENTIONAL STUDY. REGISTRY OF ADVERSE EVENTS (AES)/SUSPECTED ADVERSE DRUG REACTIONS (SADRS) OF ADULT PATIENTS UNDER TREATMENT OF DEEP VEIN THROMBOSIS (DVT) AND PULMONARY EMBOLISM (PE); PREVENTION OF RECURRENT DVT AND PE WITH ELICUIS REGISTERED (APIXABAN)
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Thrombosis, Deep Vein
Pulmonary Embolism
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2019-01-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients who have received at least one dose of apixaban for treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE); prevention of recurrent DVT and PE.

Brief summary: Number, type and incidence of adverse events/suspected adverse drug reactions in patients treated with apixaban, according to therapeutic indications approved in Mexico.


Eligibility criteria: Inclusion Criteria:

Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:

1. Evidence a personally 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.
2. Patients (men and women) \>18 years old.
3. Patients who have received at least one dose of apixaban for treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE); prevention of recurrent DVT and PE

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Exclusion Criteria:

Patients meeting any of the following criteria will not be included in the study:

1. Patients who are participating in a clinical trial.
2. Hypersensitivity to the active substance or to any of the excipients.
3. Active clinically significant bleeding.
4. Hepatic disease associated with coagulopathy and clinically relevant bleeding risk, based on hepatic function tests.
5. Lesion or condition if 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 hemorrhage, known or suspected esophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities.
6. 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, acenocoumarin, rivaroxaban, dabigatran, etc.) except under specific circumstances of switching anticoagulant therapy.
7. Pregnancy and breast-feeding.
8. Severe acute or chronic psychiatric condition and other significant medical condition.

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Primary outcomes:
measure: The number, type and incidence of adverse events/suspected adverse drug reactions in patients treated with apixaban, according to therapeutic indications approved in Mexico.
timeFrame: 12 up to 24 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: