A Study of Adverse Events and Suspected Adverse Drug Reactions of Patients Under Treatment of Apixaban for Venous Thomboembolism (VTE) Treatment

Pulmonary Embolism Clinical Trial

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)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03812835
• Other study ID #: B0661104
• Status: Withdrawn
• Start date: August 23, 2021
• Est. completion date: August 23, 2023

Study information

• Verified date: November 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 23, 2023
• Est. primary completion date: August 23, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 - 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. -

Related Conditions & MeSH terms

• Drug-Related Side Effects and Adverse Reactions
• Embolism
• Pulmonary Embolism
• Thrombosis
• Thrombosis, Deep Vein
• Venous Thrombosis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number, type and incidence of adverse events/suspected adverse drug reactions in patients treated with apixaban, according to therapeutic indications approved in Mexico.	Data will be collected for at least 12 months and until 24 months in 3 sites in Mexico using an electronic case report form	12 up to 24 months