beta-alanine and Venous Thrombosis studies

Venous Thrombosis: The formation or presence of a blood clot (THROMBUS) within a vein.

Research Excerpts

Excerpt	Relevance	Reference
" Less bleeding but more acute coronary events with dabigatran, and still no antidote."	7.81	Dabigatran (Pradaxa): deep vein thrombosis and pulmonary embolism. Warfarin remains the standard drug. ( , 2015)
" A second woman with primary APS experienced ischemic arterial strokes and right transverse-sigmoid sinus thrombosis after conversion to rivaroxaban."	7.80	Failure of dabigatran and rivaroxaban to prevent thromboembolism in antiphospholipid syndrome: a case series of three patients. ( Black, DF; McBane, RD; Moder, KG; Schaefer, JK; Williams, LN; Wysokinski, WE, 2014)
"Dabigatran was not superior to enoxaparin for prevention of VTE (RR 1."	6.47	Dabigatran and rivaroxaban for prevention of venous thromboembolism--systematic review and adjusted indirect comparison. ( Kwok, CS; Loke, YK, 2011)
"Chest pain is a common clinical event that overwhelms many patients and is often a sign of coronary ischaemia."	5.40	Chest pain caused by pulmonary vein thrombi could be curable by dabigatran. ( Takeuchi, H, 2014)
"Rivaroxaban is the first TSOAC to gain widespread approval for the treatment of acute deep vein thrombosis and pulmonary embolism and the long-term prevention of recurrent VTE as monotherapy."	4.90	The potential of target-specific oral anticoagulants for the acute and long-term treatment of venous thromboembolism. ( Akwaa, F; Spyropoulos, AC, 2014)
" The US Food and Drug Administration recently approved 2 new oral anticoagulants, dabigatran and rivaroxaban, for stroke prevention in patients with atrial fibrillation, and is currently reviewing a drug application for a third new oral anticoagulant, apixaban."	4.89	Novel oral anticoagulants: a review of new agents. ( Wanat, MA, 2013)
"Indications for use of the new anticoagulants include thromboprophylaxis after total hip and knee replacement surgery (all three), prevention of stroke and systemic embolism in non-valvular atrial fibrillation (all three), treatment of acute venous thrombosis and secondary prophylaxis after venous thrombosis (currently only rivaroxaban)."	4.89	New oral anticoagulants--a review. ( Atar, D; Ghanima, W; Sandset, PM, 2013)
" The factor Xa inhibitor, rivaroxaban, has shown promising results in the treatment of acute coronary syndrome but is not yet approved for that indication."	4.88	What did we learn from new oral anticoagulant treatment? ( Esmon, CT, 2012)
" Less bleeding but more acute coronary events with dabigatran, and still no antidote."	3.81	Dabigatran (Pradaxa): deep vein thrombosis and pulmonary embolism. Warfarin remains the standard drug. ( , 2015)
" A second woman with primary APS experienced ischemic arterial strokes and right transverse-sigmoid sinus thrombosis after conversion to rivaroxaban."	3.80	Failure of dabigatran and rivaroxaban to prevent thromboembolism in antiphospholipid syndrome: a case series of three patients. ( Black, DF; McBane, RD; Moder, KG; Schaefer, JK; Williams, LN; Wysokinski, WE, 2014)
"Risk for symptomatic deep venous thrombosis, but not risk for death or nonfatal pulmonary embolism, was reduced with factor Xa inhibitors compared with LMWH (4 fewer events per 1000 patients)."	2.49	Comparative effectiveness of new oral anticoagulants and standard thromboprophylaxis in patients having total hip or knee replacement: a systematic review. ( Adam, SS; Lachiewicz, PF; McDuffie, JR; Ortel, TL; Williams, JW, 2013)
"Dabigatran was not superior to enoxaparin for prevention of VTE (RR 1."	2.47	Dabigatran and rivaroxaban for prevention of venous thromboembolism--systematic review and adjusted indirect comparison. ( Kwok, CS; Loke, YK, 2011)
" Clinicians are increasingly being challenged with making uncertain anticoagulant dosing decisions, as the optimal dosing strategy for most anticoagulants in the obese patient population remains unknown."	2.47	Anticoagulating obese patients in the modern era. ( Arya, R; Patel, JP; Roberts, LN, 2011)
"Dabigatran was administered at a dose of 110-150 mg once or twice daily, depending on the renal function and age."	1.42	Efficacy of Dabigatran for Dissolving Deep Vein Thromboses in Outpatients With a Deteriorated General Condition. ( Fujino, T; Ikeda, T; Kabuki, T; Kiuchi, S; Kobayashi, K; Yamazaki, A; Yamazaki, J; Yamazaki, Y, 2015)
"Chest pain is a common clinical event that overwhelms many patients and is often a sign of coronary ischaemia."	1.40	Chest pain caused by pulmonary vein thrombi could be curable by dabigatran. ( Takeuchi, H, 2014)
"Dabigatran is a relatively novel therapeutic option for patients with AF."	1.39	Floating thrombus in the left upper pulmonary vein dissolved by dabigatran. ( Takeuchi, H, 2013)
"Cerebral venous thrombosis is an uncommon condition with difficulties in diagnosis and treatment."	1.38	Use of direct thrombin inhibitor for treatment of cerebral venous thrombosis. ( Cheng, PW; Hon, SF; Li, HL, 2012)

Research

Studies (32)

Authors

Clinical Trials (3)

Trial Overview

Trial Outcomes

Number of Participants Who Died During Treatment Period

Timeframe	Studies, this research(%)	All Research%
pre-1990	0 (0.00)	18.7374
1990's	0 (0.00)	18.2507
2000's	0 (0.00)	29.6817
2010's	32 (100.00)	24.3611
2020's	0 (0.00)	2.80

Authors	Studies
Yang, XZ	1
Diao, XJ	1
Yang, WH	1
Li, F	1
He, GW	1
Gong, GQ	1
Xu, YG	1
Nieto Rodríguez, JA	1
Wanat, MA	1
Adam, SS	1
McDuffie, JR	1
Lachiewicz, PF	1
Ortel, TL	1
Williams, JW	1
Ghanima, W	1
Atar, D	1
Sandset, PM	1
Takeuchi, H	2
Prandoni, P	2
Barbar, S	1
Milan, M	1
Vedovetto, V	1
Pesavento, R	1
Degirmenci, SE	1
Steib, A	1
Wood, P	1
Herrmann, R	1
Thom, J	1
Wood, A	1
Phillips, M	1
Muhammad, S	1
Baker, R	1
Vo, T	1
Vazquez, S	1
Rondina, MT	1
Akwaa, F	1
Spyropoulos, AC	1
Schaefer, JK	1
McBane, RD	1
Black, DF	1
Williams, LN	1
Moder, KG	1
Wysokinski, WE	1
Sengupta, N	1
Feuerstein, JD	1
Patwardhan, VR	1
Tapper, EB	1
Ketwaroo, GA	1
Thaker, AM	1
Leffler, DA	1
Karetová, D	1
Bultas, J	1
Fujino, T	1
Yamazaki, Y	1
Yamazaki, A	1
Kabuki, T	1
Kiuchi, S	1
Kobayashi, K	1
Yamazaki, J	1
Ikeda, T	1
Loke, YK	1
Kwok, CS	1
Eriksson, BI	1
Dahl, OE	1
Huo, MH	1
Kurth, AA	1
Hantel, S	1
Hermansson, K	1
Schnee, JM	1
Friedman, RJ	1
Ageno, W	1
Beyer-Westendorf, J	1
Werth, S	1
Folprecht, G	1
Weiss, N	1
Patel, JP	1
Roberts, LN	1
Arya, R	1
Galanis, T	1
Kraft, WK	1
Merli, GJ	1
Combe, S	1
Büller, HR	1
Hon, SF	1
Li, HL	1
Cheng, PW	1
Sinauridze, EI	1
Panteleev, MA	1
Ataullakhanov, FI	1
Twig, G	1
Furer, A	1
Yaniv, G	1
Michael, L	1
Karplus, R	1
Amital, H	1
Turpie, AG	1
Kreutz, R	1
Llau, J	1
Norrving, B	1
Haas, S	1
Esmon, CT	1
Coccheri, S	1
Orlando, D	1

Trial	Phase	Enrollment	Study Type	Start Date	Status
A Phase III Randomised, Parallel Group, Double-blind, Active Controlled Study to Investigate the Efficacy and Safety of Orally Administered 220 mg Dabigatran Etexilate Capsules (110 mg Administered on the Day of Surgery Followed by 220 mg Once Daily) Comp[NCT00657150]	Phase 3	2,055 participants (Actual)	Interventional	2008-03-31	Completed
Prospective Observational Study of the Direct Oral Anticoagulants Periprocedural Management[NCT03182218]		1,100 participants (Actual)	Observational	2015-02-28	Completed
Prospective Study of the Assessment of the Dental Protocol for Tooth Extraction in Patients With Atrial Fibrillation in Continuous Use of New Oral Anticoagulants: A Pilot Study[NCT03181386]	Phase 3	60 participants (Actual)	Interventional	2017-05-03	Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

All cause death, as adjudicated by the VTE events committee (NCT00657150)
Timeframe: 28-35 days

Number of Participants With Major Venous Thromboembolic Event and Venous Thromboembolic Event-related Mortality During Treatment Period

Intervention	Participants (Number)
Dabigatran 220mg	0
Enoxaparin	1

Major Venous Thromboembolic Event (VTE) is defined as proximal DVT and PE, as adjudicated by the VTE events committee (NCT00657150)
Timeframe: 28-35 days

Number of Participants With Proximal Deep Vein Thrombosis During Treatment Period

Intervention	Participants (Number)
Dabigatran 220mg	18
Enoxaparin	33

Proximal Deep Vein Thrombosis as adjudicated by the VTE events committee (NCT00657150)
Timeframe: 28-35 days

Number of Participants With Pulmonary Embolism During Treatment Period

Intervention	Participants (Number)
Dabigatran 220mg	17
Enoxaparin	31

Pulmonary embolism confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy, and as adjudicated by the VTE events committee (NCT00657150)
Timeframe: 28-35 days

Number of Participants With Symptomatic Deep Vein Thrombosis During Treatment Period

Intervention	Participants (Number)
Dabigatran 220mg	1
Enoxaparin	2

Symptomatic Deep Vein Thrombosis, confirmed by venous duplex, ultrasound, venography or autopsy, and as adjudicated by the VTE events committee (NCT00657150)
Timeframe: 28-35 days

Number of Participants With Total Deep Vein Thrombosis During Treatment Period

Intervention	Participants (Number)
Dabigatran 220mg	0
Enoxaparin	4

Total Deep Vein Thrombosis as adjudicated by the VTE events committee (NCT00657150)
Timeframe: 28-35 days

Number of Participants With Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period

Intervention	Participants (Number)
Dabigatran 220mg	60
Enoxaparin	67

"Total Venous Thromboembolic Event (VTE) includes both proximal and distal deep vein thrombosis (DVT) (detected by routine venography), symptomatic DVT (confirmed by venous duplex, ultrasound, venography or autopsy) and pulmonary embolism (PE) (confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy).~All of these components and all deaths were centrally adjudicated by the VTE events committee, which was not aware of the treatment allocation of the patients." (NCT00657150)
Timeframe: 28-35 days

Volume of Blood Loss

Intervention	Participants (Number)
Dabigatran 220mg	61
Enoxaparin	69

Volume of blood loss for treated and operated patients during surgery. (NCT00657150)
Timeframe: Day 1

Blood Transfusion

Intervention	mL (Mean)
Dabigatran 220mg	404.9
Enoxaparin	411.0

Number of treated and operated patients with required blood transfusion on day of surgery. (NCT00657150)
Timeframe: Day 1

Laboratory Analyses

Intervention	participants (Number)
	Transfusions required	Missing
Dabigatran 220mg	246	4
Enoxaparin	237	7

Frequency of patients with possible clinically significant abnormalities. (NCT00657150)
Timeframe: First administration to end of study

Number of Participants With Bleeding Events (Defined According to Modified McMaster Criteria) During Treatment Period

Intervention	participants (Number)
	AST increase N=(964;962)	AST decrease N=(964;962)	ALT increase N=(966;962)	ALT decrease N=(966;962)	Bilirubin increase N=(966;962)	Bilirubin decrease N=(966;962)
Dabigatran 220mg	28	0	34	0	3	0
Enoxaparin	44	0	67	0	1	0

"Major bleeding events were defined as~fatal~clinically overt associated with loss of haemoglobin >=20g/L in excess of what was expected~clinically overt leading to the transfusion of >=2 units packed cells or whole blood in excess of what was expected~symptomatic retroperitoneal, intracranial, intraocular or intraspinal~requiring treatment cessation~leading to re-operation~Clinically-relevant was defined as~spontaneous skin hematoma >=25 cm²~wound hematoma >=100 cm²~spontaneous nose bleed >5 min~macroscopic hematuria spontaneous or >24 hours if associated with an intervention~spontaneous rectal bleeding~gingival bleeding >5 min~any other bleeding event considered clinically relevant by the investigator~Any bleeding events were defined as major, clinically-relevant and minor bleeding events. Minor bleeding events were defined as all other bleeding events that did not fulfil the criteria from above." (NCT00657150)
Timeframe: 28-35 days

Number of Participants With Total Venous Thromboembolic Event (VTE) and All-cause Mortality During the Follow-up Period

Intervention	Participants (Number)
	Major bleeding events	Major and clinically relevant bleeding events	Any bleeding events
Dabigatran 220mg	14	37	98
Enoxaparin	9	29	83

Total Venous Thromboembolic Event (VTE) includes both proximal and distal deep vein thrombosis (DVT) (detected by routine venography), symptomatic DVT (confirmed by venous duplex, ultrasound, venography or autopsy) and pulmonary embolism (PE) (confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy). (NCT00657150)
Timeframe: 3 months

Article	Year
[New approaches in the treatment of deep vein thrombosis]. Medicina clinica, 2012, Volume: 139 Suppl 2 Topics: Administration, Oral; Anticoagulants; Benzimidazoles; beta-Alanine; Biotin; Clinical Trials, Phase I	2012
Novel oral anticoagulants: a review of new agents. Postgraduate medicine, 2013, Volume: 125, Issue:4 Topics: Anticoagulants; Atrial Fibrillation; Benzimidazoles; beta-Alanine; Dabigatran; Drug Administration S	2013
Comparative effectiveness of new oral anticoagulants and standard thromboprophylaxis in patients having total hip or knee replacement: a systematic review. Annals of internal medicine, 2013, Aug-20, Volume: 159, Issue:4 Topics: Administration, Oral; Anticoagulants; Arthroplasty, Replacement, Hip; Arthroplasty, Replacement, Kne	2013
New oral anticoagulants--a review. Tidsskrift for den Norske laegeforening : tidsskrift for praktisk medicin, ny raekke, 2013, Oct-01, Volume: 133, Issue:18 Topics: Administration, Oral; Anticoagulants; Atrial Fibrillation; Benzimidazoles; beta-Alanine; Dabigatran;	2013
The risk of recurrent thromboembolic disorders in patients with unprovoked venous thromboembolism: new scenarios and opportunities. European journal of internal medicine, 2014, Volume: 25, Issue:1 Topics: Age Factors; Anticoagulants; Aspirin; Benzimidazoles; beta-Alanine; Dabigatran; Disease Management;	2014
Current state of anticoagulants to treat deep venous thrombosis. Current cardiology reports, 2014, Volume: 16, Issue:3 Topics: Anticoagulants; Benzimidazoles; beta-Alanine; Dabigatran; Humans; Medication Adherence; Morpholines;	2014
The potential of target-specific oral anticoagulants for the acute and long-term treatment of venous thromboembolism. Current medical research and opinion, 2014, Volume: 30, Issue:11 Topics: Anticoagulants; Benzimidazoles; beta-Alanine; Dabigatran; Heparin; Humans; Morpholines; Pulmonary Em	2014
Dabigatran and rivaroxaban for prevention of venous thromboembolism--systematic review and adjusted indirect comparison. Journal of clinical pharmacy and therapeutics, 2011, Volume: 36, Issue:1 Topics: Anticoagulants; Antithrombins; Benzimidazoles; beta-Alanine; Dabigatran; Enoxaparin; Factor Xa Inhib	2011
Anticoagulating obese patients in the modern era. British journal of haematology, 2011, Volume: 155, Issue:2 Topics: Acute Coronary Syndrome; Anticoagulants; Benzimidazoles; beta-Alanine; Clinical Trials as Topic; Dab	2011
Prophylaxis for deep vein thrombosis and pulmonary embolism in the surgical patient. Advances in surgery, 2011, Volume: 45 Topics: Anticoagulants; Arthroplasty, Replacement, Knee; Benzimidazoles; beta-Alanine; Dabigatran; Factor Xa	2011
Anticoagulant therapy: basic principles, classic approaches and recent developments. Blood coagulation & fibrinolysis : an international journal in haemostasis and thrombosis, 2012, Volume: 23, Issue:6 Topics: Anticoagulants; Benzimidazoles; beta-Alanine; Blood Coagulation; Dabigatran; Factor Xa; Factor Xa In	2012
Management consensus guidance for the use of rivaroxaban--an oral, direct factor Xa inhibitor. Thrombosis and haemostasis, 2012, Volume: 108, Issue:5 Topics: Anticoagulants; Arthroplasty, Replacement, Hip; Arthroplasty, Replacement, Knee; Atrial Fibrillation	2012
Management consensus guidance for the use of rivaroxaban--an oral, direct factor Xa inhibitor. Thrombosis and haemostasis, 2012, Volume: 108, Issue:5 Topics: Anticoagulants; Arthroplasty, Replacement, Hip; Arthroplasty, Replacement, Knee; Atrial Fibrillation	2012
Management consensus guidance for the use of rivaroxaban--an oral, direct factor Xa inhibitor. Thrombosis and haemostasis, 2012, Volume: 108, Issue:5 Topics: Anticoagulants; Arthroplasty, Replacement, Hip; Arthroplasty, Replacement, Knee; Atrial Fibrillation	2012
Management consensus guidance for the use of rivaroxaban--an oral, direct factor Xa inhibitor. Thrombosis and haemostasis, 2012, Volume: 108, Issue:5 Topics: Anticoagulants; Arthroplasty, Replacement, Hip; Arthroplasty, Replacement, Knee; Atrial Fibrillation	2012
What did we learn from new oral anticoagulant treatment? Thrombosis research, 2012, Volume: 130 Suppl 1 Topics: Acute Coronary Syndrome; Administration, Oral; Anticoagulants; Antithrombins; Atrial Fibrillation; B	2012
New oral anticoagulants in atrial fibrillation: a reappraisal of trial results looking at absolute figures. Internal and emergency medicine, 2013, Volume: 8, Issue:2 Topics: Administration, Oral; Anticoagulants; Atrial Fibrillation; Benzimidazoles; beta-Alanine; Clinical Tr	2013

Article	Year
Dabigatran "non-inferior" to warfarin, but only just. BMJ (Clinical research ed.), 2013, Feb-27, Volume: 346 Topics: Administration, Oral; Anticoagulants; Antithrombins; Benzimidazoles; beta-Alanine; Clinical Trials a	2013
Design, synthesis and antithrombotic evaluation of novel dabigatran prodrugs containing methyl ferulate. Bioorganic & medicinal chemistry letters, 2013, Apr-01, Volume: 23, Issue:7 Topics: Benzimidazoles; beta-Alanine; Caffeic Acids; Dabigatran; Dose-Response Relationship, Drug; Drug Desi	2013
Floating thrombus in the left upper pulmonary vein dissolved by dabigatran. BMJ case reports, 2013, Oct-09, Volume: 2013 Topics: Aged; Antithrombins; Benzimidazoles; beta-Alanine; Dabigatran; Diagnosis, Differential; Echocardiogr	2013
[New direct oral anticoagulants and venous thromboprophylaxis]. La Revue du praticien, 2013, Volume: 63, Issue:7 Topics: Administration, Oral; Anticoagulants; Benzimidazoles; beta-Alanine; Dabigatran; Humans; Morpholines;	2013
New oral anticoagulants: an emergency department overview. Emergency medicine Australasia : EMA, 2013, Volume: 25, Issue:6 Topics: Administration, Oral; Anticoagulants; Atrial Fibrillation; Australia; Benzimidazoles; beta-Alanine;	2013
Thrombin generation using the calibrated automated thrombinoscope to assess reversibility of dabigatran and rivaroxaban. Thrombosis and haemostasis, 2014, May-05, Volume: 111, Issue:5 Topics: Anticoagulants; Arthroplasty, Replacement, Hip; Arthroplasty, Replacement, Knee; Atrial Fibrillation	2014
Chest pain caused by pulmonary vein thrombi could be curable by dabigatran. BMJ case reports, 2014, Mar-13, Volume: 2014 Topics: Aged; Antithrombins; Benzimidazoles; beta-Alanine; Chest Pain; Dabigatran; Humans; Male; Multidetect	2014
Failure of dabigatran and rivaroxaban to prevent thromboembolism in antiphospholipid syndrome: a case series of three patients. Thrombosis and haemostasis, 2014, Volume: 112, Issue:5 Topics: Adult; Anticoagulants; Antiphospholipid Syndrome; Benzimidazoles; beta-Alanine; Cerebral Infarction;	2014
The risks of thromboembolism vs. recurrent gastrointestinal bleeding after interruption of systemic anticoagulation in hospitalized inpatients with gastrointestinal bleeding: a prospective study. The American journal of gastroenterology, 2015, Volume: 110, Issue:2 Topics: Aged; Aged, 80 and over; Anticoagulants; Benzimidazoles; beta-Alanine; Cohort Studies; Dabigatran; E	2015
[Extended options of anticoagulant treatment in thromboembolism]. Vnitrni lekarstvi, 2014, Volume: 60, Issue:11 Topics: Administration, Oral; Aged; Antithrombins; Benzimidazoles; beta-Alanine; Czech Republic; Dabigatran;	2014
Efficacy of Dabigatran for Dissolving Deep Vein Thromboses in Outpatients With a Deteriorated General Condition. International heart journal, 2015, Volume: 56, Issue:4 Topics: Administration, Oral; Aged; Anticoagulants; Atrial Fibrillation; Benzimidazoles; beta-Alanine; Dabig	2015
Dabigatran (Pradaxa): deep vein thrombosis and pulmonary embolism. Warfarin remains the standard drug. Prescrire international, 2015, Volume: 24, Issue:161 Topics: Administration, Oral; Anticoagulants; Benzimidazoles; beta-Alanine; Blood Coagulation; Blood Coagula	2015
New insights on the role of direct thrombin inhibitors for the prevention of venous thromboembolism after major orthopaedic surgery. Thrombosis and haemostasis, 2011, Volume: 105, Issue:4 Topics: Anticoagulants; Antithrombins; Arthroplasty, Replacement, Hip; Benzimidazoles; beta-Alanine; Dabigat	2011
Trousseau's syndrome in a patient with adenocarcinoma of unknown primary and therapy-resistant venous thrombosis treated with dabigatran and fondaparinux. British journal of clinical pharmacology, 2011, Volume: 72, Issue:4 Topics: Adenocarcinoma; Anticoagulants; Benzimidazoles; beta-Alanine; Dabigatran; Drug Resistance; Drug Ther	2011
[New treatments for venous thromboembolic disease]. Journal des maladies vasculaires, 2011, Volume: 36 Suppl 1 Topics: Anticoagulants; Benzimidazoles; beta-Alanine; Dabigatran; Heparin; Humans; Morpholines; Pulmonary Em	2011
Use of direct thrombin inhibitor for treatment of cerebral venous thrombosis. Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association, 2012, Volume: 21, Issue:8 Topics: Adult; Antithrombins; Benzimidazoles; beta-Alanine; Cerebral Angiography; Dabigatran; Humans; Intrac	2012
Dabigatran in recurrent deep vein thrombosis: when one-size does not fit all. The Israel Medical Association journal : IMAJ, 2012, Volume: 14, Issue:7 Topics: Aged, 80 and over; Anticoagulants; Benzimidazoles; beta-Alanine; Dabigatran; Humans; Male; Recurrenc	2012

beta-alanine and Venous Thrombosis