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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
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The ADIOS study is a prospective, observational study will evaluate one hundred and thirty (130) patients with non-valvular atrial fibrillation who are currently receiving treatment with apixaban as indicated to reduce the risk of stroke or systemic embolism, and who require an elective major surgical or invasive procedure will be included in the study. The purpose of the study is to evaluate the efficacy of the recommended pre-procedure washout period of 48 hours.
This study will estimate for what proportion of patients a 48 hour pre-procedure apixaban discontinuation is sufficient to achieve minimal apixaban plasma levels (less than 30 ng/mL) prior to surgery. The investigators hypothesize that this portion will be 80-95%.
All patients will have a blood draw at 48 hours prior to procedure and then a second blood draw on the morning of the procedure to test apixaban plasma and anti-Xa levels. Patients will also receive a follow-up phone call at 30 days to collect information on clinical events.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lab tests for plasma levels of apixaban and anti-10a factor | Other | All patients will have a blood draw at 48 hours prior to elective surgical procedure and then a second blood draw on the morning of the procedure to test apixaban plasma and anti-Xa levels. |
| Measure | Description | Time Frame |
|---|---|---|
| Apixaban plasma concentration | Determine whether the recommended 48 hour pre-procedure discontinuation period is sufficient to achieve minimal apixaban plasma concentration of < 30 ng/ml prior to surgery | Prior to elective surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-10a apixaban plasma concentration | Assess changes in anti-Xa apixaban levels following apixaban discontinuation but prior to the procedure | Prior to elective surgery |
| 30 day outcomes assessment |
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Inclusion Criteria:
Exclusion Criteria:
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130 patients who are currently receiving treatment with apixaban for non-valvular atrial fibrillation and scheduled for an elective surgical procedure.
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| Name | Affiliation | Role |
|---|---|---|
| Geno J. Merli, MD | Thomas Jefferson University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34809507 | Derived | Merli GJ, Kraft WK, Eraso LH, Galanis T, Thomson LJ, Ouma GO, Viscusi E, Gong JZ, Lam E. Apixaban Discontinuation for Invasive Or major Surgical procedures (ADIOS): A prospective cohort study. Vasc Med. 2022 Jun;27(3):269-276. doi: 10.1177/1358863X211047270. Epub 2021 Nov 22. |
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| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| D013923 | Thromboembolism |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
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Incidence of major events within 30 days including bleeding events, arterial thromboembolic events, and deaths caused by bleeding or thrombosis.
| Up to 30 days post- procedure |
| D002318 | Cardiovascular Diseases |