Management of Antiplatelet Regimen During Surgical Procedures

NCT03981835 | Completed DMC

• 1 other identifier: STU-2018-0398
• Study Type: observational
• Target: 147
• Locations: 1 country
• Sites: 5

Brief Summary

There are key differences today in clinical practice regarding perioperative management of post-PCI patients on DAPT undergoing NCS. Moreover, there are significant differences between bridging agents, and improved safety of current-generation DES. Given the significant limitations of current studies a well-designed registry to study current U.S. practice patterns and the bleeding or ischemic risks associated with the various perioperative DAPT management strategies including bridging and no bridging will significantly add to the understanding of the current problem and associated risks of patients. These data could form the basis for conducting future randomized clinical trials (RCTs) in this area. NCS in post-PCI patients on chronic DAPT presents a complex interaction of both ischemic and bleeding risks. The MARS registry will study the area of perioperative antiplatelet therapy management through a multicenter observational national registry designed to collect pre-operative, intra-operative and post-operative clinical strategies, therapeutic interventions and outcomes data. This proposal outlines the role of a highly experienced clinical trial team to conduct a multicenter prospective registry. This question is highly relevant to a diverse group of medical providers and millions of patients in the US and around the world; this will be the first such U.S. registry to address this critically important public health issue. Study objectives: i. To collect data on contemporary clinical practice in the U.S. on managing post percutaneous coronary intervention (PCI) DAPT in patients scheduled to undergo NCS and CS. ii. To assess ischemic and bleeding endpoints in this group of patients during the study period. iii. To generate initial data to plan for future large-scale randomized clinical trials on perioperative management of DAPT.

Conditions

Cardiac Surgery; Surgery; Percutaneous Coronary Intervention; Surgery--Complications

Outcome Measures

Primary Outcomes (1)

• Rate of Net adverse cardiovascular events (NACE) over the study period

  A composite of cardiovascular (CV) death, non-fatal myocardial infarction (MI), ischemic stroke, need for urgent coronary revascularization (UCR) or Bleeding Academic Research Consortium (BARC) ≥3 bleeding during the study period.

  2 weeks prior to surgery to up to 30 days post-surgery

Secondary Outcomes (7)

• Incidence of individual components of NACE over the study period

  2 weeks prior to surgery to up to 30 days post-surgery

• Incidence of IV antiplatelet (APT) bridging and comparison of IV APT bridging and no bridging strategies.

  2 weeks prior to surgery to up to 30 days post-surgery

• Time to NACE

  2 weeks prior to surgery to up to 30 days post-surgery

• All-cause mortality

  2 weeks prior to surgery to up to 30 days post-surgery

• Incidence of definite and probable stent thrombosis (ST).

  2 weeks prior to surgery to up to 30 days post-surgery

Study Arms (2)

Post -PCI Patients scheduled for Cardiac Surgery

Post -PCI Patients (PCI within the last 2 years) who are currently on Dual- Antiplatelet (DAPT) Medication or have a current indication for DAPT, who will be undergoing Cardiac Surgery. No intervention will be administered.

Post -PCI Patients scheduled for Non- Cardiac Surgery

Post -PCI Patients (PCI within the last 2 years) who are currently on Dual- Antiplatelet (DAPT) Medication or have a current indication for DAPT, who will be undergoing Non-Cardiac Surgery. No intervention will be administered.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Post-PCI patients on DAPT undergoing NCS and CS. Patients will be asked to sign an informed consent form (ICF) based on the mandate of their respective institutional review boards (IRB).

You may qualify if:

• Patients with PCI within the past 2 years who: a. Are currently on DAPT, OR b. Have a current indication for DAPT
• Scheduled for NCS or CS.
• Willing and able to provide an informed consent (if needed based on institutional IRB requirements).

You may not qualify if:

• Emergent (6 hours) surgery post-PCI on DAPT that precludes a thorough informed consent process.

Sponsors & Collaborators

• Baylor Research Institute: lead

Study Sites (5)

University of Florida

Jacksonville, Florida, 32209, United States

Location

Dallas VA Medical Center

Dallas, Texas, 75216, United States

Location

Baylor Scott & White Research Institute

Dallas, Texas, 75226, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Mary Washington Hospital

Fredericksburg, Virginia, 22401, United States

Location

Related Publications (43)

• Auerbach DI, Maeda JL, Steiner C. Hospital Stays with Cardiac Stents, 2009. 2012 Apr. In: Healthcare Cost and Utilization Project (HCUP) Statistical Briefs [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2006 Feb-. Statistical Brief #128. Available from http://www.ncbi.nlm.nih.gov/books/NBK97358/

  PMID: 22696778 BACKGROUND

• Bangalore S, Gupta N, Guo Y, Feit F. Trend in the use of drug eluting stents in the United States: insight from over 8.1 million coronary interventions. Int J Cardiol. 2014 Jul 15;175(1):108-19. doi: 10.1016/j.ijcard.2014.04.269. Epub 2014 May 9.

  PMID: 24852837 BACKGROUND

• 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; ACCF; AHA; SCAI. 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention: executive summary: 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. Catheter Cardiovasc Interv. 2012 Feb 15;79(3):453-95. doi: 10.1002/ccd.23438. No abstract available.

  PMID: 22328235 BACKGROUND

• Capodanno D, Angiolillo DJ. Management of antiplatelet therapy in patients with coronary artery disease requiring cardiac and noncardiac surgery. Circulation. 2013 Dec 24;128(25):2785-98. doi: 10.1161/CIRCULATIONAHA.113.003675. No abstract available.

  PMID: 24366588 BACKGROUND

• Bonaca MP, Braunwald E, Sabatine MS. Long-Term Use of Ticagrelor in Patients with Prior Myocardial Infarction. N Engl J Med. 2015 Sep 24;373(13):1274-5. doi: 10.1056/NEJMc1508692. No abstract available.

  PMID: 26398078 BACKGROUND

• Alshawabkeh LI, Prasad A, Lenkovsky F, Makary LF, Kandil ES, Weideman RA, Kelly KC, Rangan BV, Banerjee S, Brilakis ES. Outcomes of a preoperative "bridging" strategy with glycoprotein IIb/IIIa inhibitors to prevent perioperative stent thrombosis in patients with drug-eluting stents who undergo surgery necessitating interruption of thienopyridine administration. EuroIntervention. 2013 Jun 22;9(2):204-11. doi: 10.4244/EIJV9I2A35.

  PMID: 23454910 BACKGROUND

• Habib A, Finn AV. Endothelialization of drug eluting stents and its impact on dual anti-platelet therapy duration. Pharmacol Res. 2015 Mar;93:22-7. doi: 10.1016/j.phrs.2014.12.003. Epub 2014 Dec 19.

  PMID: 25533811 BACKGROUND

• McFadden EP, Stabile E, Regar E, Cheneau E, Ong AT, Kinnaird T, Suddath WO, Weissman NJ, Torguson R, Kent KM, Pichard AD, Satler LF, Waksman R, Serruys PW. Late thrombosis in drug-eluting coronary stents after discontinuation of antiplatelet therapy. Lancet. 2004 Oct 23-29;364(9444):1519-21. doi: 10.1016/S0140-6736(04)17275-9.

  PMID: 15500897 BACKGROUND

• Ong AT, Hoye A, Aoki J, van Mieghem CA, Rodriguez Granillo GA, Sonnenschein K, Regar E, McFadden EP, Sianos G, van der Giessen WJ, de Jaegere PP, de Feyter P, van Domburg RT, Serruys PW. Thirty-day incidence and six-month clinical outcome of thrombotic stent occlusion after bare-metal, sirolimus, or paclitaxel stent implantation. J Am Coll Cardiol. 2005 Mar 15;45(6):947-53. doi: 10.1016/j.jacc.2004.09.079.

  PMID: 15766834 BACKGROUND

• Regar E, Lemos PA, Saia F, Degertekin M, Tanabe K, Lee CH, Arampatzis CA, Hoye A, Sianos G, de Feyter P, van der Giessen WJ, Smits PC, van Domburg RT, Serruys PW. Incidence of thrombotic stent occlusion during the first three months after sirolimus-eluting stent implantation in 500 consecutive patients. Am J Cardiol. 2004 May 15;93(10):1271-5. doi: 10.1016/j.amjcard.2004.02.013.

  PMID: 15135702 BACKGROUND

• Iakovou I, Schmidt T, Bonizzoni E, Ge L, Sangiorgi GM, Stankovic G, Airoldi F, Chieffo A, Montorfano M, Carlino M, Michev I, Corvaja N, Briguori C, Gerckens U, Grube E, Colombo A. Incidence, predictors, and outcome of thrombosis after successful implantation of drug-eluting stents. JAMA. 2005 May 4;293(17):2126-30. doi: 10.1001/jama.293.17.2126.

  PMID: 15870416 BACKGROUND

• Rossini R, Musumeci G, Capodanno D, Lettieri C, Limbruno U, Tarantini G, Russo N, Calabria P, Romano M, Inashvili A, Sirbu V, Guagliumi G, Valsecchi O, Senni M, Gavazzi A, Angiolillo DJ. Perioperative management of oral antiplatelet therapy and clinical outcomes in coronary stent patients undergoing surgery. Results of a multicentre registry. Thromb Haemost. 2015 Feb;113(2):272-82. doi: 10.1160/TH14-05-0436. Epub 2014 Oct 2.

  PMID: 25274620 BACKGROUND

• Silber S, Kirtane AJ, Belardi JA, Liu M, Brar S, Rothman M, Windecker S. Lack of association between dual antiplatelet therapy use and stent thrombosis between 1 and 12 months following resolute zotarolimus-eluting stent implantation. Eur Heart J. 2014 Aug 1;35(29):1949-56. doi: 10.1093/eurheartj/ehu026. Epub 2014 Feb 7.

  PMID: 24510638 BACKGROUND

• Fleisher LA, Fleischmann KE, Auerbach AD, Barnason SA, Beckman JA, Bozkurt B, Davila-Roman VG, Gerhard-Herman MD, Holly TA, Kane GC, Marine JE, Nelson MT, Spencer CC, Thompson A, Ting HH, Uretsky BF, Wijeysundera DN. 2014 ACC/AHA guideline on perioperative cardiovascular evaluation and management of patients undergoing noncardiac surgery: executive summary: a report of the American College of Cardiology/American Heart Association Task Force on practice guidelines. Developed in collaboration with the American College of Surgeons, American Society of Anesthesiologists, American Society of Echocardiography, American Society of Nuclear Cardiology, Heart Rhythm Society, Society for Cardiovascular Angiography and Interventions, Society of Cardiovascular Anesthesiologists, and Society of Vascular Medicine Endorsed by the Society of Hospital Medicine. J Nucl Cardiol. 2015 Feb;22(1):162-215. doi: 10.1007/s12350-014-0025-z. No abstract available.

  PMID: 25523415 BACKGROUND

• Hawn MT, Graham LA, Richman JS, Itani KM, Henderson WG, Maddox TM. Risk of major adverse cardiac events following noncardiac surgery in patients with coronary stents. JAMA. 2013 Oct 9;310(14):1462-72. doi: 10.1001/jama.2013.278787.

  PMID: 24101118 BACKGROUND

• Brilakis ES, Banerjee S. Patient with coronary stents needs surgery: what to do? JAMA. 2013 Oct 9;310(14):1451-2. doi: 10.1001/jama.2013.279123. No abstract available.

  PMID: 24101010 BACKGROUND

• Luckie M, Khattar RS, Fraser D. Non-cardiac surgery and antiplatelet therapy following coronary artery stenting. Heart. 2009 Aug;95(16):1303-8. doi: 10.1136/hrt.2008.161273. Epub 2009 Feb 12.

  PMID: 19218260 BACKGROUND

• Palmerini T, Biondi-Zoccai G, Della Riva D, Mariani A, Genereux P, Branzi A, Stone GW. Stent thrombosis with drug-eluting stents: is the paradigm shifting? J Am Coll Cardiol. 2013 Nov 19;62(21):1915-1921. doi: 10.1016/j.jacc.2013.08.725. Epub 2013 Sep 11.

  PMID: 24036025 BACKGROUND

• Mehran R, Rao SV, Bhatt DL, Gibson CM, Caixeta A, Eikelboom J, Kaul S, Wiviott SD, Menon V, Nikolsky E, Serebruany V, Valgimigli M, Vranckx P, Taggart D, Sabik JF, Cutlip DE, Krucoff MW, Ohman EM, Steg PG, White H. Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium. Circulation. 2011 Jun 14;123(23):2736-47. doi: 10.1161/CIRCULATIONAHA.110.009449. No abstract available.

  PMID: 21670242 BACKGROUND

• Mehran R, Baber U, Steg PG, Ariti C, Weisz G, Witzenbichler B, Henry TD, Kini AS, Stuckey T, Cohen DJ, Berger PB, Iakovou I, Dangas G, Waksman R, Antoniucci D, Sartori S, Krucoff MW, Hermiller JB, Shawl F, Gibson CM, Chieffo A, Alu M, Moliterno DJ, Colombo A, Pocock S. Cessation of dual antiplatelet treatment and cardiac events after percutaneous coronary intervention (PARIS): 2 year results from a prospective observational study. Lancet. 2013 Nov 23;382(9906):1714-22. doi: 10.1016/S0140-6736(13)61720-1. Epub 2013 Sep 1.

  PMID: 24004642 BACKGROUND

• Singla S, Sachdeva R, Uretsky BF. The risk of adverse cardiac and bleeding events following noncardiac surgery relative to antiplatelet therapy in patients with prior percutaneous coronary intervention. J Am Coll Cardiol. 2012 Nov 13;60(20):2005-16. doi: 10.1016/j.jacc.2012.04.062. Epub 2012 Oct 17.

  PMID: 23083781 BACKGROUND

• Chalhoub V, Pottecher J, Asehnoune K, Mazoit JX, Duranteau J, Benhamou D. Cytokine response and reactive oxygen species production after low- and intermediate-risk surgery. Acta Anaesthesiol Scand. 2011 May;55(5):549-57. doi: 10.1111/j.1399-6576.2011.02419.x. Epub 2011 Mar 21.

  PMID: 21418155 BACKGROUND

• Brilakis ES, Banerjee S, Berger PB. Perioperative management of patients with coronary stents. J Am Coll Cardiol. 2007 Jun 5;49(22):2145-50. doi: 10.1016/j.jacc.2007.02.046. Epub 2007 May 23.

  PMID: 17543633 BACKGROUND

• Saia F, Belotti LM, Guastaroba P, Berardini A, Rossini R, Musumeci G, Tarantini G, Campo G, Guiducci V, Tarantino F, Menozzi A, Varani E, Santarelli A, Tondi S, De Palma R, Rapezzi C, Marzocchi A. Risk of Adverse Cardiac and Bleeding Events Following Cardiac and Noncardiac Surgery in Patients With Coronary Stent: How Important Is the Interplay Between Stent Type and Time From Stenting to Surgery? Circ Cardiovasc Qual Outcomes. 2016 Jan;9(1):39-47. doi: 10.1161/CIRCOUTCOMES.115.002155. Epub 2015 Dec 8.

  PMID: 26646819 BACKGROUND

• Capodanno D, Musumeci G, Lettieri C, Limbruno U, Senni M, Guagliumi G, Valsecchi O, Angiolillo DJ, Rossini R. Impact of bridging with perioperative low-molecular-weight heparin on cardiac and bleeding outcomes of stented patients undergoing non-cardiac surgery. Thromb Haemost. 2015 Aug;114(2):423-31. doi: 10.1160/TH14-12-1057. Epub 2015 May 28.

  PMID: 26017898 BACKGROUND

• Brilakis ES, Banerjee S. Perioperative management of drug-eluting stents: the Achilles heel of bridging. Catheter Cardiovasc Interv. 2013 Dec 1;82(7):1113-4. doi: 10.1002/ccd.25243. No abstract available.

  PMID: 24255030 BACKGROUND

• Rossini R, Capodanno D, Lettieri C, Musumeci G, Nijaradze T, Romano M, Lortkipanidze N, Cicorella N, Biondi Zoccai G, Sirbu V, Izzo A, Guagliumi G, Valsecchi O, Gavazzi A, Angiolillo DJ. Prevalence, predictors, and long-term prognosis of premature discontinuation of oral antiplatelet therapy after drug eluting stent implantation. Am J Cardiol. 2011 Jan 15;107(2):186-94. doi: 10.1016/j.amjcard.2010.08.067.

  PMID: 21211596 BACKGROUND

• Gerber Y, Rihal CS, Sundt TM 3rd, Killian JM, Weston SA, Therneau TM, Roger VL. Coronary revascularization in the community. A population-based study, 1990 to 2004. J Am Coll Cardiol. 2007 Sep 25;50(13):1223-9. doi: 10.1016/j.jacc.2007.06.022. Epub 2007 Sep 10.

  PMID: 17888838 BACKGROUND

• Go AS, Mozaffarian D, Roger VL, Benjamin EJ, Berry JD, Blaha MJ, Dai S, Ford ES, Fox CS, Franco S, Fullerton HJ, Gillespie C, Hailpern SM, Heit JA, Howard VJ, Huffman MD, Judd SE, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Mackey RH, Magid DJ, Marcus GM, Marelli A, Matchar DB, McGuire DK, Mohler ER 3rd, Moy CS, Mussolino ME, Neumar RW, Nichol G, Pandey DK, Paynter NP, Reeves MJ, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Wong ND, Woo D, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Executive summary: heart disease and stroke statistics--2014 update: a report from the American Heart Association. Circulation. 2014 Jan 21;129(3):399-410. doi: 10.1161/01.cir.0000442015.53336.12. No abstract available.

  PMID: 24446411 BACKGROUND

• Rossini R, Musumeci G, Visconti LO, Bramucci E, Castiglioni B, De Servi S, Lettieri C, Lettino M, Piccaluga E, Savonitto S, Trabattoni D, Capodanno D, Buffoli F, Parolari A, Dionigi G, Boni L, Biglioli F, Valdatta L, Droghetti A, Bozzani A, Setacci C, Ravelli P, Crescini C, Staurenghi G, Scarone P, Francetti L, D'Angelo F, Gadda F, Comel A, Salvi L, Lorini L, Antonelli M, Bovenzi F, Cremonesi A, Angiolillo DJ, Guagliumi G; Italian Society of Invasive Cardiology (SICI-GISE); Italian Association of Hospital Cardiologists (ANMCO); Italian Society for Cardiac Surgery (SICCH); Italian Society of Vascular and Endovascular Surgery (SICVE); Italian Association of Hospital Surgeons (ACOI); Italian Society of Surgery (SIC); Italian Society of Anaesthesia and Intensive Care Medicine (SIAARTI); Lombard Society of Surgery (SLC); Italian Society of Maxillofacial Surgery (SICMF); Italian Society of Reconstructive Plastic Surgery and Aesthetics (SICPRE); Italian Society of Thoracic Surgeons (SICT); Italian Society of Urology (SIU); Italian Society of Orthopaedics and Traumatology (SIOT); Italian Society of Periodontology (SIdP); Italian Federation of Scientific Societies of Digestive System Diseases Lombardia (FISMAD); Association of Obstetricians Gynaecologists Italian Hospital Lombardia (AOGOI); Society of Ophthalmology Lombardia (SOL). Perioperative management of antiplatelet therapy in patients with coronary stents undergoing cardiac and non-cardiac surgery: a consensus document from Italian cardiological, surgical and anaesthesiological societies. EuroIntervention. 2014 May;10(1):38-46. doi: 10.4244/EIJV10I1A8.

  PMID: 24832636 BACKGROUND

• Savonitto S, D'Urbano M, Caracciolo M, Barlocco F, Mariani G, Nichelatti M, Klugmann S, De Servi S. Urgent surgery in patients with a recently implanted coronary drug-eluting stent: a phase II study of 'bridging' antiplatelet therapy with tirofiban during temporary withdrawal of clopidogrel. Br J Anaesth. 2010 Mar;104(3):285-91. doi: 10.1093/bja/aep373. Epub 2010 Jan 3.

  PMID: 20047898 BACKGROUND

• Rassi AN, Blackstone E, Militello MA, Theodos G, Cavender MA, Sun Z, Ellis SG, Cho L. Safety of "bridging" with eptifibatide for patients with coronary stents before cardiac and non-cardiac surgery. Am J Cardiol. 2012 Aug 15;110(4):485-90. doi: 10.1016/j.amjcard.2012.04.016. Epub 2012 May 15.

  PMID: 22591672 BACKGROUND

• Warshauer J, Patel VG, Christopoulos G, Kotsia AP, Banerjee S, Brilakis ES. Outcomes of preoperative bridging therapy for patients undergoing surgery after coronary stent implantation: a weighted meta-analysis of 280 patients from eight studies. Catheter Cardiovasc Interv. 2015 Jan 1;85(1):25-31. doi: 10.1002/ccd.25507. Epub 2014 May 6.

  PMID: 24740634 BACKGROUND

• Barra ME, Fanikos J, Gerhard-Herman MD, Bhatt DL. Bridging Experience With Eptifibatide After Stent Implantation. Crit Pathw Cardiol. 2016 Sep;15(3):82-8. doi: 10.1097/HPC.0000000000000084.

  PMID: 27465001 BACKGROUND

• Waldron NH, Dallas T, Erhunmwunsee L, Wang TY, Berry MF, Welsby IJ. Bleeding risk associated with eptifibatide (Integrilin) bridging in thoracic surgery patients. J Thromb Thrombolysis. 2017 Feb;43(2):194-202. doi: 10.1007/s11239-016-1441-5.

  PMID: 27798792 BACKGROUND

• Walker EA, Dager WE. Bridging with Tirofiban during Oral Antiplatelet Interruption: A Single-Center Case Series Analysis Including Patients on Hemodialysis. Pharmacotherapy. 2017 Aug;37(8):888-892. doi: 10.1002/phar.1956. Epub 2017 Jul 6.

  PMID: 28543216 BACKGROUND

• Stern G, Rimsans J, Qamar A, Vaduganathan M, Bhatt DL. Contemporary parenteral antiplatelet bridging strategies: a single-centre real-world experience at a tertiary care centre. EuroIntervention. 2018 Jun 8;14(3):e333-e335. doi: 10.4244/EIJ-D-18-00036. No abstract available.

  PMID: 29537373 BACKGROUND

• Urban P, Meredith IT, Abizaid A, Pocock SJ, Carrie D, Naber C, Lipiecki J, Richardt G, Iniguez A, Brunel P, Valdes-Chavarri M, Garot P, Talwar S, Berland J, Abdellaoui M, Eberli F, Oldroyd K, Zambahari R, Gregson J, Greene S, Stoll HP, Morice MC; LEADERS FREE Investigators. Polymer-free Drug-Coated Coronary Stents in Patients at High Bleeding Risk. N Engl J Med. 2015 Nov 19;373(21):2038-47. doi: 10.1056/NEJMoa1503943. Epub 2015 Oct 14.

  PMID: 26466021 BACKGROUND

• Budaj A. Bleeding and Quality of Life. J Am Coll Cardiol. 2016 Jan 5;67(1):66-8. doi: 10.1016/j.jacc.2015.10.035. No abstract available.

  PMID: 26764068 BACKGROUND

• Weinstein MC, Stason WB. Foundations of cost-effectiveness analysis for health and medical practices. N Engl J Med. 1977 Mar 31;296(13):716-21. doi: 10.1056/NEJM197703312961304.

  PMID: 402576 BACKGROUND

• Cutlip DE, Windecker S, Mehran R, Boam A, Cohen DJ, van Es GA, Steg PG, Morel MA, Mauri L, Vranckx P, McFadden E, Lansky A, Hamon M, Krucoff MW, Serruys PW; Academic Research Consortium. Clinical end points in coronary stent trials: a case for standardized definitions. Circulation. 2007 May 1;115(17):2344-51. doi: 10.1161/CIRCULATIONAHA.106.685313.

  PMID: 17470709 BACKGROUND

• Nalysnyk L, Fahrbach K, Reynolds MW, Zhao SZ, Ross S. Adverse events in coronary artery bypass graft (CABG) trials: a systematic review and analysis. Heart. 2003 Jul;89(7):767-72. doi: 10.1136/heart.89.7.767.

  PMID: 12807853 BACKGROUND

• Angiolillo DJ, Firstenberg MS, Price MJ, Tummala PE, Hutyra M, Welsby IJ, Voeltz MD, Chandna H, Ramaiah C, Brtko M, Cannon L, Dyke C, Liu T, Montalescot G, Manoukian SV, Prats J, Topol EJ; BRIDGE Investigators. Bridging antiplatelet therapy with cangrelor in patients undergoing cardiac surgery: a randomized controlled trial. JAMA. 2012 Jan 18;307(3):265-74. doi: 10.1001/jama.2011.2002.

  PMID: 22253393 BACKGROUND

Study Officials

• Subhash Banerjee, MD

  Baylor Scott & White Research Institute

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2019
• First Posted: June 11, 2019
• Study Start: August 1, 2019
• Primary Completion: January 30, 2024
• Study Completion: January 30, 2024
• Last Updated: February 6, 2026

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)