Apixaban in Patients Who Undergo CIED Procedure- Randomized Pilot Study

Atrial Fibrillation Clinical Trial

— Apixaban  

Official title:

Evaluate the Safety of Apixaban in Patients Who Undergo Cardiovascular Implantable Electronic Device (CIED) Procedure: A Randomized Pilot Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02450682
• Other study ID #: 14-005395
• Status: Withdrawn
• Phase: Phase 2
• First received: May 19, 2015
• Last updated: January 14, 2016
• Start date: February 2016
• Est. completion date: March 2017

Study information

• Verified date: January 2016
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study is being done to determine if apixaban is more safe, when compared to warfarin, at reducing the risk of bleeding during CIED procedures.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

1. Signed informed written consent

2. Patients are taking warfarin or apixaban chronically

3. Patients are at risk of stroke or systemic embolism

4. Patients have NVAF

5. Patients will undergo CIED generator change

6. Age 18-90

7. Either gender

8. All eligibility criteria must be met

Exclusion:

1. Patient is critically ill, or in unstable condition

2. Patient is at high risk for bleeding, HAS-BLED score = 3

3. Patient is required to take dual antiplatelet agents in addition to anticoagulant drug. (e.g. recent cardiac stent placement)

4. Patients have mechanical cardiac valve or another condition other than NVAF that requires chronic anticoagulation

5. Women of childbearing potential with positive pregnant test

6. Bilirubin >2x upper limit of normal, in association with AST/ALT/ALP >3x upper limit normal

7. Allergy to apixaban and warfarin

8. Subjects requiring taking strong dual inhibitors of CYP3A4 and P-gp who already meet the criteria to take 2.5 mg apixaban

9. Subjects requiring taking strong dual inducers of CYP3A4 and P-gp (.e.g., rifampin, carbamazepine, phenytoin, St. John's wort)

10. Patients who take any investigational drugs within 30 days of enrolling in study.

11. Prisoners or subjects who are involuntarily incarcerated.

12. Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• Apixaban
Anticoagulant agent for Atrial Fibrillation and undergo CIED generator change
• Warfarin
Anticoagulant agent for Atrial Fibrillation and undergo CIED generator change

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	decrease in the hemoglobin level of 2 g per deciliter or more	Assess the risk of major bleeding when continuing apixaban through the procedure as compared to Warfarin.	2 months	Yes