Trial Protocol: A randomised controlled trial of extended anticoagulation treatment versus routine anticoagulation treatment for the prevention of recurrent VTE and post thrombotic syndrome in patients being treated for a first episode of unprovoked VTE (The ExACT Study)

BMC Cardiovascular Disorders

Volumn 13, Issue , 2013, Pages

  Tullett, Jayne ^a   Murray, Ellen ^a   Nichols, Linda ^a   Holder, Roger ^a   Lester, Will ^b   Rose, Peter ^c   Hobbs, F D R ^d   Fitzmaurice, David ^a  

^a UNIVERSITY OF BIRMINGHAM   (United Kingdom)

^b QUEEN ELIZABETH HOSPITAL   (United Kingdom)

^c WARWICK HOSPITAL   (United Kingdom)

^d UNIVERSITY OF OXFORD   (United Kingdom)

Author keywords

D dimer; Deep vein thrombosis; Extended warfarin; Post thrombotic syndrome; Pulmonary embolism; Venous thromboembolism

Indexed keywords

D DIMER; HEPARIN; WARFARIN;

ADULT; ANTICOAGULANT THERAPY; ARTICLE; CHRONIC VEIN INSUFFICIENCY; CLINICAL PROTOCOL; CONTROLLED STUDY; COST EFFECTIVENESS ANALYSIS; DEEP VEIN THROMBOSIS; DISEASE SEVERITY; DRUG SAFETY; FOLLOW UP; HUMAN; IDIOPATHIC DISEASE; INCIDENCE; INTERNATIONAL NORMALIZED RATIO; LUNG EMBOLISM; MAJOR CLINICAL STUDY; POSTTHROMBOSIS SYNDROME; PRIORITY JOURNAL; PROTEIN BLOOD LEVEL; QUALITY OF LIFE; QUESTIONNAIRE; RANDOMIZED CONTROLLED TRIAL; RATING SCALE; RECURRENCE RISK; RECURRENT DISEASE; THROMBOSIS PREVENTION; TREATMENT DURATION; ULCER; VENOUS THROMBOEMBOLISM;

ADMINISTRATION, ORAL; ANTICOAGULANTS; BIOLOGICAL MARKERS; CLINICAL PROTOCOLS; DRUG ADMINISTRATION SCHEDULE; ENGLAND; FIBRIN FIBRINOGEN DEGRADATION PRODUCTS; HUMANS; POSTTHROMBOTIC SYNDROME; PRIMARY HEALTH CARE; QUALITY OF LIFE; QUESTIONNAIRES; RECURRENCE; RESEARCH DESIGN; TIME FACTORS; TREATMENT OUTCOME; VENOUS THROMBOEMBOLISM; WARFARIN;

EID: 84874701834     PISSN: None     EISSN: 14712261     Source Type: Journal    
DOI: 10.1186/1471-2261-13-16     Document Type: Article

References (26)

1. Ramzi DW, Leeper KV. DVT and pulmonary embolism: part 2. Treatment and prevention. Am Fam Physician 2004, 15, 69(12):2841-2848.
2. BCSH Haemostasis and Thrombosis Task Force Guidelines on oral anticoagulation: third edition. Br J Haem 1998, 101:374-387. BCSH Haemostasis and Thrombosis Task Force.
3. Agnelli G, Prandoni P, Santamaria MG. Warfarin Optimum Duration Trial Investigators. Three months versus one year of oral anticoagulant therapy for idiopathic deep venous thrombosis. N Engl J Med 2001, 345(3):165-169. 10.1056/NEJM200107193450302, 11463010.
4. Anand SS. Comparison of 3 and 6 months of oral anticoagulation therapy after a first episode of proximal deep vein vein thrombosis or pulmonary embolism and comparison of 6 and 12 weeks of therapy after isolated calf deep vein thrombosis. Vasc Med 2001, 6(4):269-70. 10.1177/1358836X0100600413, 11958396.
5. Holmgren K, Andersson G, Fagrell B. One month versus six month therapy with oral anticoagulation after symptomatic deep vein thrombosis. Acta Med Scand 1985, 3:279-84.
6. Astermark J, Bjorgell O, Linden E. Low recurrence rate after deep calf-vein thrombosis with 6 weeks of oral anticoagulation. J Inter Med 1998, 244(1):79-82.
7. Palareti G, Legani C, Cosmi B. Risk of venous thromboembolism recurrence: high negative predictive value of D-dimer performed after oral anticoagulation is stopped. Thromb Haemost 2002, 87(1):7-12.
8. Hansson PO, Sorbo J, Eriksson H. Recurrent venous thromboembolism after deep venous thrombosis: incidence and risk factors. Arch intern Med 2000, 160(6):769-74. 10.1001/archinte.160.6.769, 10737276.
9. Kearon C, Gent M, Hirsch J. A comparison of three months of anticoagulation with extended anticoagulation for a first episode of idiopathic venous thromboembolism. N Engl J Med 1999, 340(12):901-907. 10.1056/NEJM199903253401201, 10089183.
10. Baglin T, Palmer CR, Luddington R, Baglin C. Unprovoked recurrent venous thrombosis: prediction by D-dimer and clinical risk factors. J Thromb Haemost 2008, 6:577-582. 10.1111/j.1538-7836.2008.02889.x, 18182040.
11. Ridker PM, Goldhaber SZ, Danielson E. Long-term, low-intensity warfarin therapy for the prevention of recurrent venous thromboembolism. N Engl J Med 2003, 348(15):1425-1434. 10.1056/NEJMoa035029, 12601075.
12. Kearon C, Ginsberg JS, Kovacs MJ. Comparison of low-intensity warfarin therapy with conventional-intensity warfarin therapy for long-term prevention of recurrent venous thromboembolism. N Engl J Med 2003, 349(7):631-639. 10.1056/NEJMoa035422, 12917299.
13. Cosmi B, Legnani C, Tosetto A. Use of D-dimer testing to determine duration of anticoagulation, risk of cardiovascular events and oocult cancer after a first episode of idiopathic venous thromboembolism: the extended follow-up of the PROLONG study. J Thromb Thrombolysis 2009, 28:381-388. 10.1007/s11239-009-0315-5, 19288181.
14. Palareti G, Legani C, Cosmi B. Predictive value of D-dimer test for recurrent venous thromboembolism after anticoagulation withdrawal in subjects with a previous idiopathic event and in carriers of congenital thrombophilia. Circulation 2003, 108(3):313-8. 10.1161/01.CIR.0000079162.69615.0F, 12847064.
15. Kurvilla J, Wells PS, Morrow B. Prospective assessment of the natural history of positive D-dimer results in persons with acute venous thromboembolism (DVT and PE). Throb Haemost 2003, 89(2):284-7.
16. De Raucourt E, Meyer G, Landais P. Markers of hemostatic system activation in pulmonary embolism. Changes during and after cessation of anticoagulation treatment. Blood Coagul Fibrinolysis 2000, 11(3):249-253.
17. Rodger MA, Kahn SR, Wells PS, Anderson DA, Chagnon I. Identifying unprovoked thromboembolism patients at low risk for recurrence who can discontinue anticoagulant therapy. CMAJ 2008, 179(5):417-426. 2518177, 18725614.
18. Douketis J, Tosetto A, Marcucci M. Risk of recurrence after venous thromboembolism in men and women: a patient met-analysis. BMJ 2011, 342:d813. 10.1136/bmj.d813, 3044449, 21349898.
19. Verhovsek M, Douketis JD, Yi Q. Systematic review: D-dimer to predict recurrent disease after stopping anticoagulant therapy for unprovoked venous thromboembolism. Ann Int Med 2008, 149:481-490.
20. Bruinstroop E, Klok FA, van de Ree MA. Elevated D-dimer levels predict recurrence in patients with idiopathic venous thromboembolism: a meta-analysis. J Thromb Haemost 2009, 7(4):611-618. 10.1111/j.1538-7836.2009.03293.x, 19175498.
21. Kahn SR, Ginsberg JS. Relationship between deep vein thrombosis and the post thrombotic syndrome. Arch Intern Med 2004, 164:17-26. 10.1001/archinte.164.1.17, 14718318.
22. Kahn SR, Kearon C, Julian JA. Predictors of post-thrombotic syndrome during long-term treatment of proximal deep vein thrombosis. J Thromb Haemost 2005, 3:718-723. 10.1111/j.1538-7836.2005.01216.x, 15733061.
23. Latella J, Desmarais S, Miron M-J. Relation between D-dimer level, venous valvular reflux and the development of post-thrombotic syndrome after deep vein thrombosis. J Thromb Haemost 2010, 8:2169-75. 10.1111/j.1538-7836.2010.04001.x, 20670369.
24. Kahn SR, Lamping DL, Ducruet T. VEINES-QOL/Sym questionnaire was a reliable and valid disease specific quality of life measure for deep venous thrombosis. J Clin Epi 2006, 9:1049-1056.
25. Kind P, Dolan P, Gudex C, Williams A. Variations in population health status: results from a United Kingdom national questionnaire survey. BMJ 1998, 316(7133):736-41. 10.1136/bmj.316.7133.736, 28477, 9529408.
26. Kahn SR. Measurement properties of the Villalta scale to define and classify the severity of the post-thrombotic syndrome. J Thromb Haemost 2009, 7:884-888. 10.1111/j.1538-7836.2009.03339.x, 19320818.