PROCLAIM: Pilot study to examine the effects of clopidogrel on inflammatory markers in patients with metabolic syndrome receiving low-dose aspirin

Texas Heart Institute Journal

Volumn 36, Issue 6, 2009, Pages 530-539

  Willerson, James T ^a   Cable, Greg ^b   Yeh, Edward T H ^a,c  

^a ST LUKE S EPISCOPAL HOSPITAL   (United States)

^b SANOFI   (France)

^c UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER   (United States)

Author keywords

Aspirin therapeutic use; Biological markers blood; C reactive protein drug effects; CD40 ligand drug effects; Clopidogrel therapeutic use; Inflammation; Metabolic syndrome X; P selectin drug effects; Platelet aggregation inhibitors therapeutic use; Probrain natriuretic peptide, N terminal drug effects

Indexed keywords

ACETYLSALICYLIC ACID; AMINO TERMINAL PRO BRAIN NATRIURETIC PEPTIDE; BIOLOGICAL MARKER; C REACTIVE PROTEIN; CD40 LIGAND; CLOPIDOGREL; PADGEM PROTEIN; PLACEBO;

ADULT; AGED; ANKLE FRACTURE; ARTHRALGIA; ARTICLE; BLEEDING; BRONCHITIS; CLINICAL ASSESSMENT; CLINICAL PROTOCOL; CLINICAL TRIAL; COMBINATION CHEMOTHERAPY; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG EFFECT; DRUG EFFICACY; DRUG ERUPTION; DRUG FATALITY; DRUG WITHDRAWAL; DYSLIPIDEMIA; EDEMA; FEMALE; FOOT FRACTURE; GASTROINTESTINAL DISEASE; HEART PALPITATION; HUMAN; HYPERSENSITIVITY; INFECTION; INFESTATION; INFLAMMATION; LOW DRUG DOSE; MAJOR CLINICAL STUDY; MALE; METABOLIC SYNDROME X; MULTICENTER STUDY; PERIPHERAL EDEMA; PHASE 4 CLINICAL TRIAL; PILOT STUDY; PROTEIN ANALYSIS; PROTEIN EXPRESSION; PRURITUS; RANDOMIZED CONTROLLED TRIAL; SIDE EFFECT; SINUS CONGESTION; SWOLLEN THROAT; THERAPY EFFECT; THROAT DISEASE; TREATMENT DURATION; URINE PH; VERTEBRAL CANAL STENOSIS;

ADULT; AGED; AGED, 80 AND OVER; ANTI-INFLAMMATORY AGENTS; ASPIRIN; ATHEROSCLEROSIS; BIOLOGICAL MARKERS; C-REACTIVE PROTEIN; CD40 LIGAND; DOUBLE-BLIND METHOD; DRUG THERAPY, COMBINATION; FEMALE; HUMANS; INFLAMMATION MEDIATORS; LEAST-SQUARES ANALYSIS; MALE; METABOLIC SYNDROME X; MIDDLE AGED; NATRIURETIC PEPTIDE, BRAIN; P-SELECTIN; PEPTIDE FRAGMENTS; PILOT PROJECTS; PLATELET AGGREGATION INHIBITORS; THROMBOSIS; TICLOPIDINE; TIME FACTORS; TREATMENT OUTCOME; UNITED STATES; YOUNG ADULT;

EID: 76149125479     PISSN: 07302347     EISSN: 15266702     Source Type: Journal    
DOI: None     Document Type: Article

References (48)

1. Buffon A, Liuzzo G, Biasucci LM, Pasqualetti P, Ramazzotti V, Rebuzzi AG, et al. Preprocedural serum levels of C-reactive protein predict early complications and late restenosis after coronary angioplasty. J Am Coll Cardiol 1999;34(5):1512-21.
2. Ridker PM. High-sensitivity C-reactive protein: potential adjunct for global risk assessment in the primary prevention of cardiovascular disease. Circulation 2001;103(13):1813-8.
3. Ridker PM, Cushman M, Stampfer MJ, Tracy RP, Hennekens CH. Inflammation, aspirin, and the risk of cardiovascular disease in apparently healthy men [published erratum appears in N Engl J Med 1997;337(5):356]. N Engl J Med 1997;336 (14):973-9.
4. Ridker PM, Hennekens CH, Buring JE, Rifai N. C-reactive protein and other markers of inflammation in the prediction of cardiovascular disease in women. N Engl J Med 2000;342 (12):836-43.
5. Ridker PM, Rifai N, Rose L, Buring JE, Cook NR. Comparison of C-reactive protein and low-density lipoprotein cholesterol levels in the prediction of first cardiovascular events. N Engl J Med 2002;347(20):1557-65.
6. Yeh ET. CRP as a mediator of disease. Circulation 2004;109 (21 Suppl 1):II11-4.
7. Ridker PM, Danielson E, Fonseca FA, Genest J, Gotto AM Jr, Kastelein JJ, et al. Rosuvastatin to prevent vascular events in men and women with elevated C-reactive protein. N Engl J Med 2008;359(21):2195-207.
8. Albert MA, Danielson E, Rifai N, Ridker PM; PRINCE Investigators. Effect of statin therapy on C-reactive protein levels: the pravastatin inflammation/CRP evaluation (PRINCE): a randomized trial and cohort study. JAMA 2001;286(1):64-70.
9. Ridker PM, Rifai N, Clearfield M, Downs JR, Weis SE, Miles JS, et al. Measurement of C-reactive protein for the targeting of statin therapy in the primary prevention of acute coronary events. N Engl J Med 2001;344(26):1959-65.
10. Ridker PM, Rifai N, Pfeffer MA, Sacks FM, Moye LA, Goldman S, et al. Inflammation, pravastatin, and the risk of coronary events after myocardial infarction in patients with average cholesterol levels. Cholesterol and Recurrent Events (CARE) Investigators. Circulation 1998;98(9):839-44.
11. Vivekananthan DP, Bhatt DL, Chew DP, Zidar FJ, Chan AW, Moliterno DJ, et al. Effect of clopidogrel pretreatment on periprocedural rise in C-reactive protein after percutaneous coronary intervention. Am J Cardiol 2004;94(3):358-60.
12. Chew DP, Bhatt DL, Robbins MA, Mukherjee D, Roffi M, Schneider JP, et al. Effect of clopidogrel added to aspirin before percutaneous coronary intervention on the risk associated with C-reactive protein. Am J Cardiol 2001;88(6):672-4.
13. Cha JK, Jeong MH, Lee KM, Bae HR, Lim YJ, Park KW, Cheon SM. Changes in platelet P-selectin and in plasma C-reactive protein in acute atherosclerotic ischemic stroke treated with a loading dose of clopidogrel. J Thromb Thrombolysis 2002;14(2):145-50.
14. Klinkhardt U, Graff J, Harder S. Clopidogrel, but not abciximab, reduces platelet leukocyte conjugates and P-selectin expression in a human ex vivo in vitro model. Clin Pharmacol Ther 2002;71(3):176-85.
15. Quinn MJ, Bhatt DL, Zidar F, Vivekananthan D, Chew DP, Ellis SG, et al. Effect of clopidogrel pretreatment on inflammatory marker expression in patients undergoing percutaneous coronary intervention. Am J Cardiol 2004;93(6):679-84.
16. Bonora E, Kiechl S, Willeit J, Oberhollenzer F, Egger G, Bonadonna RC, Muggeo M; Bruneck study. Carotid atherosclerosis and coronary heart disease in the metabolic syndrome: prospective data from the Bruneck study. Diabetes Care 2003; 26(4):1251-7.
17. Isomaa B, Almgren P, Tuomi T, Forsen B, Lahti K, Nissen M, et al. Cardiovascular morbidity and mortality associated with the metabolic syndrome. Diabetes Care 2001;24(4):683-9.
18. Lakka HM, Laaksonen DE, Lakka TA, Niskanen LK, Kumpusalo E, Tuomilehto J, Salonen JT. The metabolic syndrome and total and cardiovascular disease mortality in middle-aged men. JAMA 2002;288(21):2709-16.
19. Executive summary of the third report of the National Cholesterol Education Program (NCEP) expert panel on detection, evaluation, and treatment of high blood cholesterol in adults (Adult Treatment Panel III). JAMA 2001;285(19):2486-97.
20. Holvoet P, Kritchevsky SB, Tracy RP, Mertens A, Rubin SM, Butler J, et al. The metabolic syndrome, circulating oxidized LDL, and risk of myocardial infarction in well-functioning elderly people in the health, aging, and body composition cohort. Diabetes 2004;53(4):1068-73.
21. Kawamoto R, Tomita H, Oka Y, Kodama A. Metabolic syndrome as a predictor of ischemic stroke in elderly persons. Intern Med 2005;44(9):922-7.
22. Bo S, Gentile L, Ciccone G, Baldi C, Benini L, Dusio F, et al. The metabolic syndrome and high C-reactive protein: prevalence and differences by sex in a southern-European populationbased cohort. Diabetes Metab Res Rev 2005;21(6):515-24.
23. Bo S, Gambino R, Uberti B, Mangiameli MP, Colosso G, Repetti E, et al. Does C-reactive protein identify a subclinical metabolic disease in healthy subjects? Eur J Clin Invest 2005; 35(4):265-70.
24. Bhatt DL, Marso SP, Hirsch AT, Ringleb PA, Hacke W, Topol EJ. Amplified benefit of clopidogrel versus aspirin in patients with diabetes mellitus. Am J Cardiol 2002;90(6):625-8.
25. An introduction to the bootstrap (monographs on statistics and applied probability). Efron B, Tibshirani RJ, editors. London: Chapman & Hall/CRC; 1993.
26. Bhatt DL, Fox KA, Hacke W, Berger PB, Black HR, Boden WE, et al. Clopidogrel and aspirin versus aspirin alone for the prevention of atherothrombotic events. N Engl J Med 2006; 354(16):1706-17.
27. Henn V, Steinbach S, Buchner K, Presek P, Kroczek RA. The inflammatory action of CD40 ligand (CD154) expressed on activated human platelets is temporally limited by coexpressed CD40. Blood 2001;98(4):1047-54. Volume 538 Clopidogrel and Inflammatory Markers in Metabolic Syndrome 36, Number 6, 2009
28. Azar RR, McKay RG, Kiernan FJ, Seecharran B, Feng YJ, Fram DB, et al. Coronary angioplasty induces a systemic inflammatory response. Am J Cardiol 1997;80(11):1476-8.
29. Dibra A, Mehilli J, Braun S, Hadamitzky M, Baum H, Dirschinger J, et al. Association between C-reactive protein levels and subsequent cardiac events among patients with stable angina treated with coronary artery stenting. Am J Med 2003; 114(9):715-22.
30. Mach F, Schonbeck U, Sukhova GK, Bourcier T, Bonnefoy JY, Pober JS, Libby P. Functional CD40 ligand is expressed on human vascular endothelial cells, smooth muscle cells, and macrophages: implications for CD40-CD40 ligand signaling in atherosclerosis. Proc Natl Acad Sci U S A 1997;94(5):1931-6.
31. Andre P, Prasad KS, Denis CV, He M, Papalia JM, Hynes RO, et al. CD40L stabilizes arterial thrombi by a beta3 integrin - dependent mechanism. Nat Med 2002;8(3):247-52.
32. Heeschen C, Dimmeler S, Hamm CW, van den Brand MJ, Boersma E, Zeiher AM, Simoons ML. Soluble CD40 ligand in acute coronary syndromes. N Engl J Med 2003;348(12): 1104-11.
33. Liuzzo G, Biasucci LM, Gallimore JR, Grillo RL, Rebuzzi AG, Pepys MB, Maseri A. The prognostic value of C-reactive protein and serum amyloid a protein in severe unstable angina. N Engl J Med 1994;331(7):417-24.
34. Azar RR, Badaoui G, Sarkis A, Kassab R, Salame E, Klayme S, et al. Effects of tirofiban and statins on high-sensitivity C-reactive protein, interleukin-6, and soluble CD40 ligand following percutaneous coronary interventions in patients with stable coronary artery disease. Am J Cardiol 2005;95(2):236-40.
35. Cipollone F, Ferri C, Desideri G, Paloscia L, Materazzo G, Mascellanti M, et al. Preprocedural level of soluble CD40L is predictive of enhanced inflammatory response and restenosis after coronary angioplasty. Circulation 2003;108(22):2776-82.
36. Yip HK, Chang LT, Sun CK, Yang CH, Hung WC, Cheng CI, et al. Impact of clopidogrel on suppression of circulating levels of soluble CD40 ligand in patients with unstable angina undergoing coronary stenting. Am J Cardiol 2006;97(2):192-4.
37. Yip HK, Wu CJ, Yang CH, Chang HW, Fang CY, Hung WC, Hang CL. Serial changes in circulating concentrations of soluble CD40 ligand and C-reactive protein in patients with unstable angina undergoing coronary stenting. Circ J 2005;69 (8):890-5.
38. Azar RR, Kassab R, Zoghbi A, Aboujaoude S, El-Osta H, Ghorra P, et al. Effects of clopidogrel on soluble CD40 ligand and on high-sensitivity C-reactive protein in patients with stable coronary artery disease. Am Heart J 2006;151(2):521. e1-4.
39. Cipollone F, Mezzetti A, Porreca E, Di Febbo C, Nutini M, Fazia M, et al. Association between enhanced soluble CD40L and prothrombotic state in hypercholesterolemia: effects of statin therapy. Circulation 2002;106(4):399-402.
40. Walter T, Szabo S, Kazmaier S, Swoboda S, Suselbeck T, Brueckmann M, et al. Effect of clopidogrel on adhesion molecules, hemostasis, and fibrinolysis in coronary heart disease. J Cardiovasc Pharmacol 2008;51(6):616-20.
41. Perneby C, Wallen NH, Hofman-Bang C, Tornvall P, Ivert T, Li N, Hjemdahl P. Effect of clopidogrel treatment on stress-induced platelet activation and myocardial ischemia in aspirintreated patients with stable coronary artery disease. Thromb Haemost 2007;98(6):1316-22.
42. Blann AD, Nadar SK, Lip GY. The adhesion molecule P-selectin and cardiovascular disease [published erratum appears in Eur Heart J 2006;27(4):501]. Eur Heart J 2003;24(24):2166-79.
43. Mulvihill NT, Foley JB, Murphy R, Crean P, Walsh M. Evidence of prolonged inf lammation in unstable angina and non-Q wave myocardial infarction. J Am Coll Cardiol 2000; 36(4):1210-6.
44. Meune C, Wahbi K, Fulla Y, Cohen-Solal A, Duboc D, Mahe I, et al. Effects of aspirin and clopidogrel on plasma brain natriuretic peptide in patients with heart failure receiving ACE inhibitors. Eur J Heart Fail 2007;9(2):197-201.
45. Vavuranakis M, Latsios G, Aggelis D, Bosinakou I, Karambelas I, Tousoulis D, et al. Randomized comparison of the effects of ASA plus clopidogrel versus ASA alone on early platelet activation in acute coronary syndromes with elevated high-sensitivity C-reactive protein and soluble CD40 ligand levels. Clin Ther 2006;28(6):860-71.
46. Maeda K, Tsutamoto T, Wada A, Mabuchi N, Hayashi M, Tsutsui T, et al. High levels of plasma brain natriuretic peptide and interleukin-6 after optimized treatment for heart failure are independent risk factors for morbidity and mortality in patients with congestive heart failure. J Am Coll Cardiol 2000; 36(5):1587-93.
47. Anand IS, Fisher LD, Chiang YT, Latini R, Masson S, Maggioni AP, et al. Changes in brain natriuretic peptide and norepinephrine over time and mortality and morbidity in the Valsartan Heart Failure Trial (Val-HeFT). Circulation 2003; 107(9):1278-83.
48. Latini R, Masson S, Anand I, Judd D, Maggioni AP, Chiang YT, et al. Effects of valsartan on circulating brain natriuretic peptide and norepinephrine in symptomatic chronic heart failure: the Valsartan Heart Failure Trial (Val-HeFT). Circulation 2002;106(19):2454-8.