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

Last updated on January 24, 2020

FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
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

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

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.

-

NCT03812835
Pfizer
Not yet recruiting
A Study of Adverse Events and Suspected Adverse Drug Reactions of Patients Under Treatment of Apixaban for Venous Thomboembolism (VTE) Treatment

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Descriptive Information
Brief Title 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)
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • 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 17, 2019)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date February 28, 2022
Estimated Primary Completion Date August 30, 2021   (Final data collection date for primary outcome measure)
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

    -

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.

    -

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 Center 1-800-718-1021 [email protected]
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03812835
Other Study ID Numbers B0661104
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/da....
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date May 2019

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

Call Now