PERIOP 2 - A Safety and Effectiveness of LMWH vs Placebo Bridging Therapy for Patients on Long Term Warfarin Requiring Temporary Interruption of Warfarin.

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ClinicalTrials.gov Identifier: NCT00432796

Recruitment Status : Active, not recruiting

First Posted : February 8, 2007

Last Update Posted : February 19, 2020

Sponsor:

Collaborators:

Canadian Institutes of Health Research (CIHR)

Pfizer

Information provided by (Responsible Party):

Michael Kovacs, Lawson Health Research Institute

No Study Results Posted on ClinicalTrials.gov for this Study

About Study Results Reporting on ClinicalTrials.gov

Recruitment Status :	Active, not recruiting
Actual Primary Completion Date :	March 2019
Estimated Study Completion Date :	December 2020

Publications:

Tu JV, Gong Y. Trends in treatment and outcomes for acute stroke patients in Ontario, 1992-1998. Arch Intern Med. 2003 Feb 10;163(3):293-7.

Kearon C, Hirsh J. Management of anticoagulation before and after elective surgery. N Engl J Med. 1997 May 22;336(21):1506-11. Review.

Vongpatanasin W, Hillis LD, Lange RA. Prosthetic heart valves. N Engl J Med. 1996 Aug 8;335(6):407-16. Review.

Cannegieter SC, Rosendaal FR, Briët E. Thromboembolic and bleeding complications in patients with mechanical heart valve prostheses. Circulation. 1994 Feb;89(2):635-41. Review.

White RH, McKittrick T, Hutchinson R, Twitchell J. Temporary discontinuation of warfarin therapy: changes in the international normalized ratio. Ann Intern Med. 1995 Jan 1;122(1):40-2.

Kovacs MJ, Rodger M, Anderson DR, Morrow B, Kells G, Kovacs J, Boyle E, Wells PS. Comparison of 10-mg and 5-mg warfarin initiation nomograms together with low-molecular-weight heparin for outpatient treatment of acute venous thromboembolism. A randomized, double-blind, controlled trial. Ann Intern Med. 2003 May 6;138(9):714-9.

Madura JA, Rookstool M, Wease G. The management of patients on chronic Coumadin therapy undergoing subsequent surgical procedures. Am Surg. 1994 Jul;60(7):542-6; discussion 546-7.

Eckman MH, Beshansky JR, Durand-Zaleski I, Levine HJ, Pauker SG. Anticoagulation for noncardiac procedures in patients with prosthetic heart valves. Does low risk mean high cost? JAMA. 1990 Mar 16;263(11):1513-21.

Katholi RE, Nolan SP, McGuire LB. The management of anticoagulation during noncardiac operations in patients with prosthetic heart valves. A prospective study. Am Heart J. 1978 Aug;96(2):163-5.

Stein PD, Alpert JS, Copeland J, Dalen JE, Goldman S, Turpie AG. Antithrombotic therapy in patients with mechanical and biological prosthetic heart valves. Chest. 1995 Oct;108(4 Suppl):371S-379S. Review. Erratum in: Chest 1996 Feb;109(2):592.

Douketis JD, Crowther MA, Cherian SS, Kearon CB. Physician preferences for perioperative anticoagulation in patients with a mechanical heart valve who are undergoing elective noncardiac surgery. Chest. 1999 Nov;116(5):1240-6.

Dunn AS, Turpie AG. Perioperative management of patients receiving oral anticoagulants: a systematic review. Arch Intern Med. 2003 Apr 28;163(8):901-8. Review.

Douketis JD, Johnson JA, Turpie AG. Low-molecular-weight heparin as bridging anticoagulation during interruption of warfarin: assessment of a standardized periprocedural anticoagulation regimen. Arch Intern Med. 2004 Jun 28;164(12):1319-26.

Spandorfer JM, Lynch S, Weitz HH, Fertel S, Merli GJ. Use of enoxaparin for the chronically anticoagulated patient before and after procedures. Am J Cardiol. 1999 Aug 15;84(4):478-80, A10.

Kovacs MJ, Kearon C, Rodger M, Anderson DR, Turpie AG, Bates SM, Desjardins L, Douketis J, Kahn SR, Solymoss S, Wells PS. Single-arm study of bridging therapy with low-molecular-weight heparin for patients at risk of arterial embolism who require temporary interruption of warfarin. Circulation. 2004 Sep 21;110(12):1658-63. Epub 2004 Sep 13.

Ferreira I, Dos L, Tornos P, Nicolau I, Permanyer-Miralda G, Soler-Soler J. Experience with enoxaparin in patients with mechanical heart valves who must withhold acenocumarol. Heart. 2003 May;89(5):527-30.

Omran H, Hammerstingl C, Schmidt H, von der Recke G, Paar WD, Lüderitz B. A prospective and randomized comparison of the safety and effects of therapeutic levels of enoxaparin versus unfractionated heparin in chronically anticoagulated patients undergoing elective cardiac catheterization. Thromb Haemost. 2003 Aug;90(2):267-71.

Tinmouth AH, Morrow BH, Cruickshank MK, Moore PM, Kovacs MJ. Dalteparin as periprocedure anticoagulation for patients on warfarin and at high risk of thrombosis. Ann Pharmacother. 2001 Jun;35(6):669-74.

POLLER L, THOMSON J. EVIDENCE FOR

Grip L, Blombäck M, Schulman S. Hypercoagulable state and thromboembolism following warfarin withdrawal in post-myocardial-infarction patients. Eur Heart J. 1991 Nov;12(11):1225-33.

Palareti G, Legnani C, Guazzaloca G, Frascaro M, Grauso F, De Rosa F, Fortunato G, Coccheri S. Activation of blood coagulation after abrupt or stepwise withdrawal of oral anticoagulants--a prospective study. Thromb Haemost. 1994 Aug;72(2):222-6.

Vallés J, Aznar J, Santos T, Villa P, Fernández A. Platelet function in patients with chronic coronary heart disease on long-term anticoagulant therapy: effect of anticoagulant stopping. Haemostasis. 1993 Jul-Aug;23(4):212-8.

Raskob GE, Durica SS, Morrissey JH, Owen WL, Comp PC. Effect of treatment with low-dose warfarin-aspirin on activated factor VII. Blood. 1995 Jun 1;85(11):3034-9.

Genewein U, Haeberli A, Straub PW, Beer JH. Rebound after cessation of oral anticoagulant therapy: the biochemical evidence. Br J Haematol. 1996 Feb;92(2):479-85.

Adjusted-dose warfarin versus low-intensity, fixed-dose warfarin plus aspirin for high-risk patients with atrial fibrillation: Stroke Prevention in Atrial Fibrillation III randomised clinical trial. Lancet. 1996 Sep 7;348(9028):633-8.

Weitz JI. Low-molecular-weight heparins. N Engl J Med. 1997 Sep 4;337(10):688-98. Review. Erratum in: N Engl J Med 1997 Nov 20;337(21):1567.

Kovacs MJ, Weir K, MacKinnon K, Keeney M, Brien WF, Cruickshank MK. Body weight does not predict for anti-Xa levels after fixed dose prophylaxis with enoxaparin after orthopedic surgery. Thromb Res. 1998 Aug 1;91(3):137-42.

Cohen M, Demers C, Gurfinkel EP, Turpie AG, Fromell GJ, Goodman S, Langer A, Califf RM, Fox KA, Premmereur J, Bigonzi F. A comparison of low-molecular-weight heparin with unfractionated heparin for unstable coronary artery disease. Efficacy and Safety of Subcutaneous Enoxaparin in Non-Q-Wave Coronary Events Study Group. N Engl J Med. 1997 Aug 14;337(7):447-52.

Low-molecular-weight heparin during instability in coronary artery disease, Fragmin during Instability in Coronary Artery Disease (FRISC) study group. Lancet. 1996 Mar 2;347(9001):561-8.

Levine M, Gent M, Hirsh J, Leclerc J, Anderson D, Weitz J, Ginsberg J, Turpie AG, Demers C, Kovacs M. A comparison of low-molecular-weight heparin administered primarily at home with unfractionated heparin administered in the hospital for proximal deep-vein thrombosis. N Engl J Med. 1996 Mar 14;334(11):677-81.

Koopman MM, Prandoni P, Piovella F, Ockelford PA, Brandjes DP, van der Meer J, Gallus AS, Simonneau G, Chesterman CH, Prins MH. Treatment of venous thrombosis with intravenous unfractionated heparin administered in the hospital as compared with subcutaneous low-molecular-weight heparin administered at home. The Tasman Study Group. N Engl J Med. 1996 Mar 14;334(11):682-7. Erratum in: N Engl J Med 1997 Oct 23;337(17):1251.

Columbus Investigators, Büller HR, Gent M, Gallus AS, Ginsberg J, Prins MH, Baildon R. Low-molecular-weight heparin in the treatment of patients with venous thromboembolism. N Engl J Med. 1997 Sep 4;337(10):657-62.

Simonneau G, Sors H, Charbonnier B, Page Y, Laaban JP, Azarian R, Laurent M, Hirsch JL, Ferrari E, Bosson JL, Mottier D, Beau B. A comparison of low-molecular-weight heparin with unfractionated heparin for acute pulmonary embolism. The THESEE Study Group. Tinzaparine ou Heparine Standard: Evaluations dans l'Embolie Pulmonaire. N Engl J Med. 1997 Sep 4;337(10):663-9.

Schafer AI, Levine MN, Konkle BA, Kearon C. Thrombotic disorders: diagnosis and treatment. Hematology Am Soc Hematol Educ Program. 2003:520-39. Review.

Hirsh J, Raschke R. Heparin and low-molecular-weight heparin: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest. 2004 Sep;126(3 Suppl):188S-203S.

Geerts WH, Pineo GF, Heit JA, Bergqvist D, Lassen MR, Colwell CW, Ray JG. Prevention of venous thromboembolism: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest. 2004 Sep;126(3 Suppl):338S-400S. Review.

Kearon C, Hirsh J. Perioperative management of patients receiving oral anticoagulants. Arch Intern Med. 2003 Nov 10;163(20):2532-3; author reply 2533.

Risk factors for stroke and efficacy of antithrombotic therapy in atrial fibrillation. Analysis of pooled data from five randomized controlled trials. Arch Intern Med. 1994 Jul 11;154(13):1449-57. Erratum in: Arch Intern Med 1994 Oct 10;154(19):2254.

Crowther MA, Julian J, McCarty D, Douketis J, Kovacs M, Biagoni L, Schnurr T, McGinnis J, Gent M, Hirsh J, Ginsberg J. Treatment of warfarin-associated coagulopathy with oral vitamin K: a randomised controlled trial. Lancet. 2000 Nov 4;356(9241):1551-3.

Kearon C, Ginsberg JS, Kovacs MJ, Anderson DR, Wells P, Julian JA, MacKinnon B, Weitz JI, Crowther MA, Dolan S, Turpie AG, Geerts W, Solymoss S, van Nguyen P, Demers C, Kahn SR, Kassis J, Rodger M, Hambleton J, Gent M; Extended Low-Intensity Anticoagulation for Thrombo-Embolism Investigators. Comparison of low-intensity warfarin therapy with conventional-intensity warfarin therapy for long-term prevention of recurrent venous thromboembolism. N Engl J Med. 2003 Aug 14;349(7):631-9.

Crowther MA, Ginsberg JS, Julian J, Denburg J, Hirsh J, Douketis J, Laskin C, Fortin P, Anderson D, Kearon C, Clarke A, Geerts W, Forgie M, Green D, Costantini L, Yacura W, Wilson S, Gent M, Kovacs MJ. A comparison of two intensities of warfarin for the prevention of recurrent thrombosis in patients with the antiphospholipid antibody syndrome. N Engl J Med. 2003 Sep 18;349(12):1133-8. Erratum in: N Engl J Med. 2003 Dec 25;349(26):2577. N Engl J Med. 2004 Jul 8;351(2):200.

Wilson JT, Hareendran A, Grant M, Baird T, Schulz UG, Muir KW, Bone I. Improving the assessment of outcomes in stroke: use of a structured interview to assign grades on the modified Rankin Scale. Stroke. 2002 Sep;33(9):2243-6.

van Swieten JC, Koudstaal PJ, Visser MC, Schouten HJ, van Gijn J. Interobserver agreement for the assessment of handicap in stroke patients. Stroke. 1988 May;19(5):604-7.

Rodger M, Bredeson C, Wells PS, Beck J, Kearns B, Huebsch LB. Cost-effectiveness of low-molecular-weight heparin and unfractionated heparin in treatment of deep vein thrombosis. CMAJ. 1998 Oct 20;159(8):931-8.

Büller HR, Davidson BL, Decousus H, Gallus A, Gent M, Piovella F, Prins MH, Raskob G, van den Berg-Segers AE, Cariou R, Leeuwenkamp O, Lensing AW; Matisse Investigators. Subcutaneous fondaparinux versus intravenous unfractionated heparin in the initial treatment of pulmonary embolism. N Engl J Med. 2003 Oct 30;349(18):1695-702. Erratum in: N Engl J Med. 2004 Jan 22;350(4):423.

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