Optimizing the Anticoagulation Regimen of Enoxaparin During Percutaneous Coronary Intervention (OPTIENOX-PCI)

Summary

The OPTIENOX-PCI is a single-center, prospective, randomized, open-label, controlled study, which is designed to assess the anticoagulation profile of: 1) High-dose (0.75 mg/kg) vs. Standard-dose (0.5 mg/kg) enoxaparin; 2) Staged-dose (0.5+0.25 mg/kg) vs. Single-dose (0.75 mg/kg) enoxaparin in about 376 patients who plan to undergo elective trans-radial coronary angiography (CAG) with or without subsequent percutaneous coronary intervention (PCI).

Timeline

Start

2017-05-12

Primary completion

2022-04-20

Completion

2022-07-14

Publications

• Results Amsterdam EA, Wenger NK, Brindis RG, Casey DE Jr, Ganiats TG, Holmes DR Jr, Jaffe AS, Jneid H, Kelly RF, Kontos MC, Levine GN, Liebson PR, Mukherjee D, Peterson ED, Sabatine MS, Smalling RW, Zieman SJ; ACC/AHA Task Force Members; Society for Cardiovascular Angiography and Interventions and the Society of Thoracic Surgeons. 2014 AHA/ACC guideline for the management of patients with non-ST-elevation acute coronary syndromes: executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2014 Dec 23;130(25):2354-94. doi: 10.1161/CIR.0000000000000133. Epub 2014 Sep 23. No abstract available.
• Results Argenti D, Hoppensteadt D, Heald D, Jensen B, Fareed J. Pharmacokinetics of enoxaparin in patients undergoing percutaneous coronary intervention with and without glycoprotein IIb/IIIa therapy. Am J Ther. 2003 Jul-Aug;10(4):241-6. doi: 10.1097/00045391-200307000-00002.
• Results Bernat I, Horak D, Stasek J, Mates M, Pesek J, Ostadal P, Hrabos V, Dusek J, Koza J, Sembera Z, Brtko M, Aschermann O, Smid M, Polansky P, Al Mawiri A, Vojacek J, Bis J, Costerousse O, Bertrand OF, Rokyta R. ST-segment elevation myocardial infarction treated by radial or femoral approach in a multicenter randomized clinical trial: the STEMI-RADIAL trial. J Am Coll Cardiol. 2014 Mar 18;63(10):964-72. doi: 10.1016/j.jacc.2013.08.1651. Epub 2013 Nov 21.
• Results Caputo RP, Tremmel JA, Rao S, Gilchrist IC, Pyne C, Pancholy S, Frasier D, Gulati R, Skelding K, Bertrand O, Patel T. Transradial arterial access for coronary and peripheral procedures: executive summary by the Transradial Committee of the SCAI. Catheter Cardiovasc Interv. 2011 Nov 15;78(6):823-39. doi: 10.1002/ccd.23052. Epub 2011 May 4.
• Results Chen WH, Lau CP, Lau YK, Ng W, Lee PY, Yu CM, Ma E. Stable and optimal anticoagulation is achieved with a single dose of intravenous enoxaparin in patients undergoing percutaneous coronary intervention. J Invasive Cardiol. 2002 Aug;14(8):439-42.
• Results Chew DP, Bhatt DL, Lincoff AM, Moliterno DJ, Brener SJ, Wolski KE, Topol EJ. Defining the optimal activated clotting time during percutaneous coronary intervention: aggregate results from 6 randomized, controlled trials. Circulation. 2001 Feb 20;103(7):961-6. doi: 10.1161/01.cir.103.7.961.
• Results Choussat R, Montalescot G, Collet JP, Vicaut E, Ankri A, Gallois V, Drobinski G, Sotirov I, Thomas D. A unique, low dose of intravenous enoxaparin in elective percutaneous coronary intervention. J Am Coll Cardiol. 2002 Dec 4;40(11):1943-50. doi: 10.1016/s0735-1097(02)02531-7.
• Results Cohen M. The role of low-molecular-weight heparin in the management of acute coronary syndromes. J Am Coll Cardiol. 2003 Feb 19;41(4 Suppl S):55S-61S. doi: 10.1016/s0735-1097(02)02901-7.
• Results Collet JP, Montalescot G, Lison L, Choussat R, Ankri A, Drobinski G, Sotirov I, Thomas D. Percutaneous coronary intervention after subcutaneous enoxaparin pretreatment in patients with unstable angina pectoris. Circulation. 2001 Feb 6;103(5):658-63. doi: 10.1161/01.cir.103.5.658.
• Results Feldman DN, Swaminathan RV, Kaltenbach LA, Baklanov DV, Kim LK, Wong SC, Minutello RM, Messenger JC, Moussa I, Garratt KN, Piana RN, Hillegass WB, Cohen MG, Gilchrist IC, Rao SV. Adoption of radial access and comparison of outcomes to femoral access in percutaneous coronary intervention: an updated report from the national cardiovascular data registry (2007-2012). Circulation. 2013 Jun 11;127(23):2295-306. doi: 10.1161/CIRCULATIONAHA.112.000536.
• Results Ferguson JJ, Dougherty KG, Gaos CM, Bush HS, Marsh KC, Leachman DR. Relation between procedural activated coagulation time and outcome after percutaneous transluminal coronary angioplasty. J Am Coll Cardiol. 1994 Apr;23(5):1061-5. doi: 10.1016/0735-1097(94)90590-8.
• Results Ferrante G, Rao SV, Juni P, Da Costa BR, Reimers B, Condorelli G, Anzuini A, Jolly SS, Bertrand OF, Krucoff MW, Windecker S, Valgimigli M. Radial Versus Femoral Access for Coronary Interventions Across the Entire Spectrum of Patients With Coronary Artery Disease: A Meta-Analysis of Randomized Trials. JACC Cardiovasc Interv. 2016 Jul 25;9(14):1419-34. doi: 10.1016/j.jcin.2016.04.014. Epub 2016 Jun 29.
• Results Giugliano RP, White JA, Bode C, Armstrong PW, Montalescot G, Lewis BS, van 't Hof A, Berdan LG, Lee KL, Strony JT, Hildemann S, Veltri E, Van de Werf F, Braunwald E, Harrington RA, Califf RM, Newby LK; EARLY ACS Investigators. Early versus delayed, provisional eptifibatide in acute coronary syndromes. N Engl J Med. 2009 May 21;360(21):2176-90. doi: 10.1056/NEJMoa0901316. Epub 2009 Mar 30.
• Results Gurm HS, Hosman C, Share D, Moscucci M, Hansen BB; Blue Cross Blue Shield of Michigan Cardiovascular Consortium. Comparative safety of vascular closure devices and manual closure among patients having percutaneous coronary intervention. Ann Intern Med. 2013 Nov 19;159(10):660-6. doi: 10.7326/0003-4819-159-10-201311190-00004.
• Results 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. doi: 10.1378/chest.126.3_suppl.188S.
• Results Karrowni W, Vyas A, Giacomino B, Schweizer M, Blevins A, Girotra S, Horwitz PA. Radial versus femoral access for primary percutaneous interventions in ST-segment elevation myocardial infarction patients: a meta-analysis of randomized controlled trials. JACC Cardiovasc Interv. 2013 Aug;6(8):814-23. doi: 10.1016/j.jcin.2013.04.010.
• Results Kereiakes DJ, Grines C, Fry E, Esente P, Hoppensteadt D, Midei M, Barr L, Matthai W, Todd M, Broderick T, Rubinstein R, Fareed J, Santoian E, Neiderman A, Brodie B, Zidar J, Ferguson JJ, Cohen M; NICE 1 and NICE 4 Investigators. National Investigators Collaborating on Enoxaparin. Enoxaparin and abciximab adjunctive pharmacotherapy during percutaneous coronary intervention. J Invasive Cardiol. 2001 Apr;13(4):272-8.
• Results Kerre S, Kustermans L, Vandendriessche T, Bosmans J, Haine SE, Miljoen H, Vrints CJ, Beutels P, Wouters K, Claeys MJ. Cost-effectiveness of contemporary vascular closure devices for the prevention of vascular complications after percutaneous coronary interventions in an all-comers PCI population. EuroIntervention. 2014 Jun;10(2):191-7. doi: 10.4244/EIJV10I2A32.
• Results Khambatta S, Othman H, Seth M, Lalonde T, Rosman HS, Gurm HS, Mehta RH; Blue Cross Blue Shield of Michigan Cardiovascular Consortium (BMC2) Investigators. Association Of Bleeding Avoidance Strategies with age-related bleeding and In-hospital mortality in patients undergoing percutaneous coronary Interventions. Cardiovasc Revasc Med. 2016 Jun;17(4):233-40. doi: 10.1016/j.carrev.2016.02.014. Epub 2016 Feb 27.
• Results Lee MS, Applegate B, Rao SV, Kirtane AJ, Seto A, Stone GW. Minimizing femoral artery access complications during percutaneous coronary intervention: a comprehensive review. Catheter Cardiovasc Interv. 2014 Jul 1;84(1):62-9. doi: 10.1002/ccd.25435. Epub 2014 Mar 10.
• Results Levine GN, Bates ER, Blankenship JC, Bailey SR, Bittl JA, Cercek B, Chambers CE, Ellis SG, Guyton RA, Hollenberg SM, Khot UN, Lange RA, Mauri L, Mehran R, Moussa ID, Mukherjee D, Nallamothu BK, Ting HH; American College of Cardiology Foundation; American Heart Association Task Force on Practice Guidelines; Society for Cardiovascular Angiography and Interventions. 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention. A report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the Society for Cardiovascular Angiography and Interventions. J Am Coll Cardiol. 2011 Dec 6;58(24):e44-122. doi: 10.1016/j.jacc.2011.08.007. Epub 2011 Nov 7. No abstract available.
• Results Martin JL, Fry ET, Sanderink GJ, Atherley TH, Guimart CM, Chevalier PJ, Ozoux ML, Pensyl CE, Bigonzi F. Reliable anticoagulation with enoxaparin in patients undergoing percutaneous coronary intervention: The pharmacokinetics of enoxaparin in PCI (PEPCI) study. Catheter Cardiovasc Interv. 2004 Feb;61(2):163-70. doi: 10.1002/ccd.10726.
• Results Mauri L, Hsieh WH, Massaro JM, Ho KK, D'Agostino R, Cutlip DE. Stent thrombosis in randomized clinical trials of drug-eluting stents. N Engl J Med. 2007 Mar 8;356(10):1020-9. doi: 10.1056/NEJMoa067731. Epub 2007 Feb 12.
• Results McGarry TF Jr, Gottlieb RS, Morganroth J, Zelenkofske SL, Kasparian H, Duca PR, Lester RM, Kreulen TH. The relationship of anticoagulation level and complications after successful percutaneous transluminal coronary angioplasty. Am Heart J. 1992 Jun;123(6):1445-51. doi: 10.1016/0002-8703(92)90793-u.
• Results Montalescot G, Collet JP, Tanguy ML, Ankri A, Payot L, Dumaine R, Choussat R, Beygui F, Gallois V, Thomas D. Anti-Xa activity relates to survival and efficacy in unselected acute coronary syndrome patients treated with enoxaparin. Circulation. 2004 Jul 27;110(4):392-8. doi: 10.1161/01.CIR.0000136830.65073.C7. Epub 2004 Jul 12.
• Results Montalescot G, White HD, Gallo R, Cohen M, Steg PG, Aylward PE, Bode C, Chiariello M, King SB 3rd, Harrington RA, Desmet WJ, Macaya C, Steinhubl SR; STEEPLE Investigators. Enoxaparin versus unfractionated heparin in elective percutaneous coronary intervention. N Engl J Med. 2006 Sep 7;355(10):1006-17. doi: 10.1056/NEJMoa052711.
• Results Montalescot G, Cohen M, Salette G, Desmet WJ, Macaya C, Aylward PE, Steg PG, White HD, Gallo R, Steinhubl SR; STEEPLE Investigators. Impact of anticoagulation levels on outcomes in patients undergoing elective percutaneous coronary intervention: insights from the STEEPLE trial. Eur Heart J. 2008 Feb;29(4):462-71. doi: 10.1093/eurheartj/ehn008.
• Results Montalescot G, Zeymer U, Silvain J, Boulanger B, Cohen M, Goldstein P, Ecollan P, Combes X, Huber K, Pollack C Jr, Benezet JF, Stibbe O, Filippi E, Teiger E, Cayla G, Elhadad S, Adnet F, Chouihed T, Gallula S, Greffet A, Aout M, Collet JP, Vicaut E; ATOLL Investigators. Intravenous enoxaparin or unfractionated heparin in primary percutaneous coronary intervention for ST-elevation myocardial infarction: the international randomised open-label ATOLL trial. Lancet. 2011 Aug 20;378(9792):693-703. doi: 10.1016/S0140-6736(11)60876-3.
• Results Narins CR, Hillegass WB Jr, Nelson CL, Tcheng JE, Harrington RA, Phillips HR, Stack RS, Califf RM. Relation between activated clotting time during angioplasty and abrupt closure. Circulation. 1996 Feb 15;93(4):667-71. doi: 10.1161/01.cir.93.4.667.
• Results Navarese EP, De Luca G, Castriota F, Kozinski M, Gurbel PA, Gibson CM, Andreotti F, Buffon A, Siller-Matula JM, Sukiennik A, De Servi S, Kubica J. Low-molecular-weight heparins vs. unfractionated heparin in the setting of percutaneous coronary intervention for ST-elevation myocardial infarction: a meta-analysis. J Thromb Haemost. 2011 Oct;9(10):1902-15. doi: 10.1111/j.1538-7836.2011.04445.x.
• Results Rao SV, Ou FS, Wang TY, Roe MT, Brindis R, Rumsfeld JS, Peterson ED. Trends in the prevalence and outcomes of radial and femoral approaches to percutaneous coronary intervention: a report from the National Cardiovascular Data Registry. JACC Cardiovasc Interv. 2008 Aug;1(4):379-86. doi: 10.1016/j.jcin.2008.05.007.
• Results Rao SV, Cohen MG, Kandzari DE, Bertrand OF, Gilchrist IC. The transradial approach to percutaneous coronary intervention: historical perspective, current concepts, and future directions. J Am Coll Cardiol. 2010 May 18;55(20):2187-95. doi: 10.1016/j.jacc.2010.01.039.
• Results Roffi M, Patrono C, Collet JP, Mueller C, Valgimigli M, Andreotti F, Bax JJ, Borger MA, Brotons C, Chew DP, Gencer B, Hasenfuss G, Kjeldsen K, Lancellotti P, Landmesser U, Mehilli J, Mukherjee D, Storey RF, Windecker S; ESC Scientific Document Group. 2015 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation: Task Force for the Management of Acute Coronary Syndromes in Patients Presenting without Persistent ST-Segment Elevation of the European Society of Cardiology (ESC). Eur Heart J. 2016 Jan 14;37(3):267-315. doi: 10.1093/eurheartj/ehv320. Epub 2015 Aug 29. No abstract available.
• Results Sachdeva S, Saha S. Transradial approach to cardiovascular interventions: an update. Int J Angiol. 2014 Jun;23(2):77-84. doi: 10.1055/s-0034-1372243.
• Results Samama MM, Gerotziafas GT. Comparative pharmacokinetics of LMWHs. Semin Thromb Hemost. 2000;26 Suppl 1:31-8. doi: 10.1055/s-2000-9497.
• Results Sanborn TA, Tomey MI, Mehran R, Genereux P, Witzenbichler B, Brener SJ, Kirtane AJ, McAndrew TC, Kornowski R, Dudek D, Nikolsky E, Stone GW. Femoral vascular closure device use, bivalirudin anticoagulation, and bleeding after primary angioplasty for STEMI: results from the HORIZONS-AMI trial. Catheter Cardiovasc Interv. 2015 Feb 15;85(3):371-9. doi: 10.1002/ccd.25663. Epub 2014 Oct 28.
• Results Sanchez-Pena P, Hulot JS, Urien S, Ankri A, Collet JP, Choussat R, Lechat P, Montalescot G. Anti-factor Xa kinetics after intravenous enoxaparin in patients undergoing percutaneous coronary intervention: a population model analysis. Br J Clin Pharmacol. 2005 Oct;60(4):364-73. doi: 10.1111/j.1365-2125.2005.02452.x.
• Results Silvain J, Beygui F, Ankri A, Bellemain-Appaix A, Pena A, Barthelemy O, Cayla G, Gallois V, Galier S, Costagliola D, Collet JP, Montalescot G. Enoxaparin anticoagulation monitoring in the catheterization laboratory using a new bedside test. J Am Coll Cardiol. 2010 Feb 16;55(7):617-25. doi: 10.1016/j.jacc.2009.08.077.
• Results Silvain J, Beygui F, Barthelemy O, Pollack C Jr, Cohen M, Zeymer U, Huber K, Goldstein P, Cayla G, Collet JP, Vicaut E, Montalescot G. Efficacy and safety of enoxaparin versus unfractionated heparin during percutaneous coronary intervention: systematic review and meta-analysis. BMJ. 2012 Feb 3;344:e553. doi: 10.1136/bmj.e553.
• Results Stone GW, White HD, Ohman EM, Bertrand ME, Lincoff AM, McLaurin BT, Cox DA, Pocock SJ, Ware JH, Feit F, Colombo A, Manoukian SV, Lansky AJ, Mehran R, Moses JW; Acute Catheterization and Urgent Intervention Triage strategy (ACUITY) trial investigators. Bivalirudin in patients with acute coronary syndromes undergoing percutaneous coronary intervention: a subgroup analysis from the Acute Catheterization and Urgent Intervention Triage strategy (ACUITY) trial. Lancet. 2007 Mar 17;369(9565):907-19. doi: 10.1016/S0140-6736(07)60450-4.
• Results Dose-ranging trial of enoxaparin for unstable angina: results of TIMI 11A. The Thrombolysis in Myocardial Infarction (TIMI) 11A Trial Investigators. J Am Coll Cardiol. 1997 Jun;29(7):1474-82.
• Results Thygesen K, Alpert JS, Jaffe AS, Simoons ML, Chaitman BR, White HD; Writing Group on the Joint ESC/ACCF/AHA/WHF Task Force for the Universal Definition of Myocardial Infarction; Thygesen K, Alpert JS, White HD, Jaffe AS, Katus HA, Apple FS, Lindahl B, Morrow DA, Chaitman BA, Clemmensen PM, Johanson P, Hod H, Underwood R, Bax JJ, Bonow RO, Pinto F, Gibbons RJ, Fox KA, Atar D, Newby LK, Galvani M, Hamm CW, Uretsky BF, Steg PG, Wijns W, Bassand JP, Menasche P, Ravkilde J, Ohman EM, Antman EM, Wallentin LC, Armstrong PW, Simoons ML, Januzzi JL, Nieminen MS, Gheorghiade M, Filippatos G, Luepker RV, Fortmann SP, Rosamond WD, Levy D, Wood D, Smith SC, Hu D, Lopez-Sendon JL, Robertson RM, Weaver D, Tendera M, Bove AA, Parkhomenko AN, Vasilieva EJ, Mendis S; ESC Committee for Practice Guidelines (CPG). Third universal definition of myocardial infarction. Eur Heart J. 2012 Oct;33(20):2551-67. doi: 10.1093/eurheartj/ehs184. Epub 2012 Aug 24. No abstract available.
• Results Tolleson TR, O'Shea JC, Bittl JA, Hillegass WB, Williams KA, Levine G, Harrington RA, Tcheng JE. Relationship between heparin anticoagulation and clinical outcomes in coronary stent intervention: observations from the ESPRIT trial. J Am Coll Cardiol. 2003 Feb 5;41(3):386-93. doi: 10.1016/s0735-1097(02)02767-5.
• Results Valgimigli M, Gagnor A, Calabro P, Frigoli E, Leonardi S, Zaro T, Rubartelli P, Briguori C, Ando G, Repetto A, Limbruno U, Cortese B, Sganzerla P, Lupi A, Galli M, Colangelo S, Ierna S, Ausiello A, Presbitero P, Sardella G, Varbella F, Esposito G, Santarelli A, Tresoldi S, Nazzaro M, Zingarelli A, de Cesare N, Rigattieri S, Tosi P, Palmieri C, Brugaletta S, Rao SV, Heg D, Rothenbuhler M, Vranckx P, Juni P; MATRIX Investigators. Radial versus femoral access in patients with acute coronary syndromes undergoing invasive management: a randomised multicentre trial. Lancet. 2015 Jun 20;385(9986):2465-76. doi: 10.1016/S0140-6736(15)60292-6. Epub 2015 Mar 16.
• Results Wimmer NJ, Secemsky EA, Mauri L, Roe MT, Saha-Chaudhuri P, Dai D, McCabe JM, Resnic FS, Gurm HS, Yeh RW. Effectiveness of Arterial Closure Devices for Preventing Complications With Percutaneous Coronary Intervention: An Instrumental Variable Analysis. Circ Cardiovasc Interv. 2016 Apr;9(4):e003464. doi: 10.1161/CIRCINTERVENTIONS.115.003464.
• Results Authors/Task Force members; Windecker S, Kolh P, Alfonso F, Collet JP, Cremer J, Falk V, Filippatos G, Hamm C, Head SJ, Juni P, Kappetein AP, Kastrati A, Knuuti J, Landmesser U, Laufer G, Neumann FJ, Richter DJ, Schauerte P, Sousa Uva M, Stefanini GG, Taggart DP, Torracca L, Valgimigli M, Wijns W, Witkowski A. 2014 ESC/EACTS Guidelines on myocardial revascularization: The Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS)Developed with the special contribution of the European Association of Percutaneous Cardiovascular Interventions (EAPCI). Eur Heart J. 2014 Oct 1;35(37):2541-619. doi: 10.1093/eurheartj/ehu278. Epub 2014 Aug 29. No abstract available.
• Wang L, Chen Q, Wang L, Zhang D, Li J, Tian R, Qian H, Zhu X, Xu L, Yang X, Zhang T, Liu Y, Liu Z, Wu W. Trough anticoagulant levels of high-dose versus standard-dose intravenous enoxaparin in patients undergoing trans-radial coronary angiography alone. BMC Cardiovasc Disord. 2026 Feb 19;26(1):257. doi: 10.1186/s12872-026-05618-x.

Drugs

Indications