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Predictors of hemorrhage among patients on direct acting oral anticoagulants

Award Number: R01HL092173
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 05/20/2008
PERIOD OF PERFORMANCE END DATE: 01/31/2026

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Predictors of hemorrhage among patients on direct acting oral anticoagulants - ABSTRACT: Direct acting oral anticoagulants (DOAC), specifically rivaroxaban (RIVA) and apixaban (APX) have emerged as the most commonly used oral anticoagulants, replacing warfarin in patients with atrial fibrillation (AF) and venous thromboembolism (VTE). However, hemorrhage (HEM) is the most feared adverse effect and is a critical barrier to institution of these efficacious therapies. Anticoagulants have consistently ranked as the top offenders for adverse drug event related hospitalizations in the US, with HEM accounting for ~80% of adm is s ions . To predict HEM risk, investigators have developed clinical prediction rules (CPRs) focused mainly on warfarin- related HEM. However, the lack of CPRs for DOAC-related HEM, the variable inclusion of antiplatelets, the lack of assessment of gastro-protective therapies or interacting drugs (influencing APX and RIVA pharmacokinetics), the lack of assessment of risk across the spectrum of kidney function, and the scarce (to nil) representation of Blacks are critical knowledge gaps. Identifying factors contributing to the increased HEM risk among APX and RIVA users and elucidating their impact (effect size) is of critical importance In this application, we aim to identify predictors of HEM risk and define the impact (effect size) in a clinical cohort of medically complex, racially diverse patients on APX (n=1500) and RIVA (N=1500) and develop CPRs for APX-related-HEM and RIVA-related-HEM. Through Aim 1, we will identify and assess the influence of predictors (e.g. demographics, comorbidities) on risk of HEM. In Aim 2, we will elucidate the influence concomitant use of antiplatelet therapy, gastro-protective therapies (proton pump inhibitors and H2 Receptor Blockers) and interacting drugs (amiodarone, diltiazem and verapamil) on risk of HEM among RIVA and APX users. Aim 3 will focus on determining the influence of chronic kidney disease (CKD) spectrum on HEM risk and elucidate steady state pharmacokinetics (PK) and pharmacodynamics (PD) across the spectrum of kidney function among RIVA and APX users. Finally, Aim 4 will incorporate results from Aims 1-3 into building CPRs to personalize the prediction of HEM among APX and RIVA users. The prediction models will validated in an independent cohort (n=500 APX, n=500 RIVA). Our focus on complex patients seen in clinical practice with robust representation of understudied patients (Blacks, patients with moderate and severe-CKD) and assessment of common co-medications improves generalizability and applicability to real world patients.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = $0 )
2025	2023	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH STREET	BIRMINGHAM	AL	35294	JEFFERSON	USA	Blood Diseases and Resources Research	000	14	1/13/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $729,872 )
2023	2023	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH ST	BIRMINGHAM	AL	35294	JEFFERSON	USA	Blood Diseases and Resources Research	000	14	2/3/2023	NON-COMPETING CONTINUATION	$729,872
														Subtotal = $729,872

Issue Date FY: 2022 ( Subtotal = $731,850 )
2022	2022	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH ST	BIRMINGHAM	AL	35294	JEFFERSON	USA	Blood Diseases and Resources Research	000	13	1/12/2022	NON-COMPETING CONTINUATION	$658,664
2022	2022	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH ST	BIRMINGHAM	AL	35294	JEFFERSON	USA	Blood Diseases and Resources Research	001	13	6/15/2022	NON-COMPETING CONTINUATION	$73,186
														Subtotal = $731,850

Issue Date FY: 2021 ( Subtotal = $732,370 )
2021	2021	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH ST	BIRMINGHAM	AL	35294	JEFFERSON	USA	Blood Diseases and Resources Research	000	12	2/3/2021	NON-COMPETING CONTINUATION	$732,370
														Subtotal = $732,370

Issue Date FY: 2020 ( Subtotal = $742,075 )
2020	2020	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH ST	BIRMINGHAM	AL	35294	JEFFERSON	USA	Blood Diseases and Resources Research	002	11	7/8/2020	COMPETING CONTINUATION	$0
2020	2020	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH ST	BIRMINGHAM	AL	35294	JEFFERSON	USA	Blood Diseases and Resources Research	000	11	12/24/2019	COMPETING CONTINUATION	$742,075
2020	2018	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH ST	BIRMINGHAM	AL	35294	JEFFERSON	USA	Blood Diseases and Resources Research	001	10	7/8/2020	NON-COMPETING CONTINUATION	$0
														Subtotal = $742,075

Issue Date FY: 2018 ( Subtotal = $711,488 )
2018	2018	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH ST	BIRMINGHAM	AL	35294	JEFFERSON	USA	Blood Diseases and Resources Research	001	10	5/12/2018	NON-COMPETING CONTINUATION	$14,230
2018	2018	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH ST	BIRMINGHAM	AL	35294	JEFFERSON	USA	Blood Diseases and Resources Research	000	10	1/31/2018	NON-COMPETING CONTINUATION	$697,258
														Subtotal = $711,488

Issue Date FY: 2017 ( Subtotal = $711,004 )
2017	2017	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH ST	BIRMINGHAM	AL	35294	JEFFERSON	USA	Blood Diseases and Resources Research	000	9	1/25/2017	NON-COMPETING CONTINUATION	$711,004
														Subtotal = $711,004

Issue Date FY: 2016 ( Subtotal = $719,078 )
2016	2016	UNIVERSITY OF ALABAMA AT BIRMINGHAM	1530 3rd Avenue South, AB 1170	BIRMINGHAM	AL	35294	JEFFERSON	USA	Blood Diseases and Resources Research	000	8	2/5/2016	NON-COMPETING CONTINUATION	$719,078
														Subtotal = $719,078

Issue Date FY: 2015 ( Subtotal = $684,219 )
2015	2015	UNIVERSITY OF ALABAMA AT BIRMINGHAM	1530 3rd Avenue South, AB 1170	BIRMINGHAM	AL	35294	JEFFERSON	USA	Blood Diseases and Resources Research	000	7	1/31/2015	NON-COMPETING CONTINUATION	$684,219
														Subtotal = $684,219

Issue Date FY: 2014 ( Subtotal = $704,923 )
2014	2014	UNIVERSITY OF ALABAMA AT BIRMINGHAM	1530 3rd Avenue South, AB 1170	BIRMINGHAM	AL	35294	JEFFERSON	USA	Blood Diseases and Resources Research	002	6	4/3/2014	COMPETING CONTINUATION	$69,324
2014	2014	UNIVERSITY OF ALABAMA AT BIRMINGHAM	1530 3rd Avenue South, AB 1170	BIRMINGHAM	AL	35294	JEFFERSON	USA	Blood Diseases and Resources Research	000	6	1/21/2014	COMPETING CONTINUATION	$635,599
2014	2012	UNIVERSITY OF ALABAMA AT BIRMINGHAM	1530 3rd Avenue South, AB 1170	BIRMINGHAM	AL	35294	JEFFERSON	USA	Blood Diseases and Resources Research	001	5	1/21/2014	NON-COMPETING CONTINUATION	$0
														Subtotal = $704,923

Issue Date FY: 2012 ( Subtotal = $712,940 )
2012	2012	UNIVERSITY OF ALABAMA AT BIRMINGHAM	UAB STATION, CBB 990	BIRMINGHAM	AL	35294	JEFFERSON	USA	Blood Diseases and Resources Research	000	5	4/24/2012	NON-COMPETING CONTINUATION	$712,940
														Subtotal = $712,940

Issue Date FY: 2011 ( Subtotal = $705,285 )
2011	2011	UNIVERSITY OF ALABAMA AT BIRMINGHAM	UAB STATION, CBB 990	BIRMINGHAM	AL	35294	JEFFERSON	USA	Blood Diseases and Resources Research	000	4	6/14/2011	NON-COMPETING CONTINUATION	$705,285
														Subtotal = $705,285

Issue Date FY: 2010 ( Subtotal = $713,486 )
2010	2010	UNIVERSITY OF ALABAMA AT BIRMINGHAM	1530 3rd Avenue South, AB 1170	BIRMINGHAM	AL	35294	JEFFERSON	USA	Blood Diseases and Resources Research	001	3	6/30/2010	NON-COMPETING CONTINUATION	$0
2010	2010	UNIVERSITY OF ALABAMA AT BIRMINGHAM	UAB STATION, CBB 990	BIRMINGHAM	AL	35294	JEFFERSON	USA	Blood Diseases and Resources Research	000	3	4/8/2010	NON-COMPETING CONTINUATION	$713,486
														Subtotal = $713,486

Issue Date FY: 2009 ( Subtotal = $1,074,745 )
2009	2009	UNIVERSITY OF ALABAMA AT BIRMINGHAM	UAB STATION, CBB 990	BIRMINGHAM	AL	35294	JEFFERSON	USA	Trans-NIH Recovery Act Research Support	002	2	7/30/2009	SUPPLEMENT FOR EXPANSION	$332,781
2009	2009	UNIVERSITY OF ALABAMA AT BIRMINGHAM	UAB STATION, CBB 990	BIRMINGHAM	AL	35294	JEFFERSON	USA	Trans-NIH Recovery Act Research Support	001	2	5/29/2009	SUPPLEMENT FOR EXPANSION	$15,777
2009	2009	UNIVERSITY OF ALABAMA AT BIRMINGHAM	UAB STATION, CBB 990	BIRMINGHAM	AL	35294	JEFFERSON	USA	Blood Diseases and Resources Research	000	2	4/10/2009	NON-COMPETING CONTINUATION	$726,187
														Subtotal = $1,074,745

Issue Date FY: 2008 ( Subtotal = $733,272 )
2008	2008	UNIVERSITY OF ALABAMA AT BIRMINGHAM	UAB STATION, CBB 990	BIRMINGHAM	AL	35294	JEFFERSON	USA	Blood Diseases and Resources Research	000	1	5/19/2008	NEW	$733,272
														Subtotal = $733,272

Grand Total All Awards = $10,406,607

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Predictors of hemorrhage among patients on direct acting oral anticoagulants

Award Number: R01HL092173

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 05/20/2008

PERIOD OF PERFORMANCE END DATE: 01/31/2026

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