Multicenter, randomized, double-blind, placebo-controlled trial of the platelet integrin glycoprotein IIb/IIIa blocker Integrelin in elective coronary intervention

Circulation

Volumn 91, Issue 8, 1995, Pages 2151-2157

  Tcheng, James E ^a   Harrington, Robert A ^a   Kottke Marchant, Kandice ^b   Kleiman, Neal S ^c   Ellis, Stephen G ^b   Kereiakes, Dean J ^d   Mick, Matthew J ^e   Navetta, Frank I ^f   Smith, Jack E ^g   Worley, Seth J ^h   Miller, Joyce A ^a   Joseph, Diane M ^a   Sigmon, Kristina N ^a   Kitt, Michael M ⁱ   Du Mée, Charles P ⁱ   Califf, Robert M ^a   Topol, Eric J ^b  

^a DUKE UNIVERSITY MEDICAL CENTER   (United States)

^b LERNER RESEARCH INSTITUTE   (United States)

^c BAYLOR COLLEGE OF MEDICINE   (United States)

^d CHRIST HOSPITAL   (United States)

^e METHODIST HOSPITAL   (United States)

^f Mother Francis Hospital   (United States)

^g St Vincent's Hospital   (United States)

^h LANCASTER GENERAL HOSPITAL   (United States)

ⁱ MILLENNIUM PHARMACEUTICALS INC   (United States)

Author keywords

angioplasty; clinical trials; coronary disease; glycoproteins; peptides; platelet aggregation inhibitors

Indexed keywords

EPTIFIBATIDE; FIBRINOGEN RECEPTOR ANTAGONIST;

ADULT; AGED; ANGINA PECTORIS; ARTICLE; ATHERECTOMY; BLEEDING; BOLUS INJECTION; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CORONARY ARTERY THROMBOSIS; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; FEMALE; HEART INFARCTION; HUMAN; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; THROMBOCYTE AGGREGATION; UNSTABLE ANGINA PECTORIS;

EID: 0028930680     PISSN: 00097322     EISSN: None     Source Type: Journal    
DOI: 10.1161/01.CIR.91.8.2151     Document Type: Article

References (30)

1. Steele PM, Chesebro JH, Stanson AW, Holmes DR Jr, Dewanjee MK, Badimon L, Fuster V. Balloon angioplasty: natural history of the pathophysiological response to injury in a pig model. Circ Res. 1985;57:105-112.
2. Minar E, Ehringer H, Ahmadi R, Dudczek R, Porenta G. Platelet deposition at angioplasty sites and platelet survival time after PTA in iliac and femoral arteries: investigations with indium-111-oxide labeled platelets in patients with ASA (1.0 g/D) therapy. Thromb Haemost. 1987;58:718-723.
3. Badimon L, Badimon JJ, Galvez A, Chesebro JH, Fuster V. Influence of arterial wall damage and wall shear rate on platelet deposition: ex vivo study in a swine model. Arteriosclerosis. 1986;6:312-320.
4. Wilentz JR, Sanborn TA, Haudenschild CC, Valeri CR, Ryan TJ, Faxon DP. Platelet accumulation in experimental angioplasty: time course in relation to cardiovascular injury. Circulation. 1987;75: 636-642.
5. Ellis SG, Bates ER, Schaible T, Weisman HF, Pitt B, Topol EJ. Prospects for the use of antagonists to the platelet glycoprotein IIb/IIIa receptor to prevent postangioplasty restenosis and thrombosis. J Am Coll Cardiol. 1991;17:89B-95B.
6. Kouns WC, Roux S, Steiner B. Human platelet GPIIb-IIIa receptor blockade as a therapeutic strategy. Curr Opin Invest Drugs. 1993;2:475-494.
7. Leung L, Nachman R. Molecular mechanisms of platelet aggregation. Annu Rev Med. 1986;37:179-186.
8. Phillips DR, Charo IF, Parise LV, Fitzgerald LA. The platelet membrane glycoprotein IIb-IIIa complex. Blood. 1988;71:831-843.
9. Coller BS. Platelets and thrombolytic therapy. N Engl J Med. 1990;322:33-42.
10. Plow EF, Pierschbacher MD, Ruoslahti E, Marguerie G, Ginsberg MH. Arginyl-glycyl-aspartic acid sequences and fibrinogen binding to activated platelets. Blood. 1987;70:110-115.
11. Dennis MS, Henzel WJ, Pitt RM, Lipari MT, Napier MT, Deisher TA, Bunting S, Lazarus RA. Platelet GP IIb/IIIa protein antagonists from snake venoms: evidence for a family of platelet aggregation inhibitors. Proc Natl Acad Sci USA. 1990;87:2471-2475.
12. Phillips DR, Charo IF, Scarborough RM. GPIIb-IIIa: the responsive integrin. Cell. 1991;65:359-362.
13. Scarborough RM, Naughton MA, Teng W, Rose JW, Phillips DR, Nannizzi L, Arfsten A, Campbell AM, Charo IF. Design of potent and specific integrin antagonists. J Biol Chem. 1993;268:1066-1073.
14. Tcheng JE, Ellis SG, George BS, Kereiakes DJ, Kleiman NS, Talley JD, Wang AL, Weisman HF, Califf RM, Topol EJ. Pharmacodynamics of chimeric glycoprotein IIb/IIIa integrin antiplatelet antibody Fab 7E3 in high-risk coronary angioplasty. Circulation. 1994;90:1757-1764.
15. The EPIC Investigators. Use of a monoclonal antibody directed against the platelet glycoprotein IIb/IIIa receptor in high-risk coronary angioplasty. N Engl J Med. 1994;330:956-961.
16. Topol EJ, Califf RM, Weisman HF, Ellis SG, Tcheng JE, Worley S, Ivanhoe R, George BS, Fintel D, Weston M, Sigmon K, Anderson KM, Lee KL, Willerson JT, on behalf of the EPIC Investigators. Randomised trial of coronary intervention with antibody against platelet IIb/IIIa integrin for reduction of clinical restenosis: results at 6 months. Lancet. 1994;343:881-886.
17. Charo IF, Scarborough RM, DuMée CP, Wolf D, Phillips DR, Swift RL. Pharmacodynamics of the GPIIb-IIIa antagonist Integrelin: phase I clinical studies in normal healthy volunteers. Circulation. 1992;86(suppl I):I-260. Abstract.
18. Rao AK, Pratt C, Berke A, Jaffe A, Ockene I. Thrombolysis in Myocardial Infarction (TIMI) Trial-Phase I: hemorrhagic manifestations and changes in plasma fibrinogen and the fibrinolytic system in patients treated with recombinant tissue plasminogen activator and streptokinase. J Am Coll Cardiol. 1988;11:1-11.
19. Landefeld CS, Cook EF, Flatley M, Weisberg M, Goldman L. Identification and preliminary validation of predictors of major bleeding in hospitalized patients starting anticoagulant therapy. Am J Med. 1987;82:703-713.
20. Ivy AC, Nelson D, Bucher G. The standardization of certain factors in the cutaneous "venostasis" bleeding time technique. J Lab Clin Med. 1941;26:1812-1822.
21. Woodman RC, Harker LA. Bleeding complications associated with cardiopulmonary bypass. Blood. 1990;76:1680-1697.
22. Schwartz L, Bourassa MG, Lesperance J, Aldridge EH, Kazim F, Salvatori VA, Henderson M, Bonan R, David PR. Aspirin and dipyridamole in the prevention of restenosis after percutaneous transluminal coronary angioplasty. N Engl J Med. 1988;318: 1714-1719.
23. Barnathan ES, Schwartz JS, Taylor L, Laskey WK, Kleaveland JP, Kussmaul WG, Hirshfeld JW. Aspirin and dipyridamole in the prevention of acute coronary thrombosis complicating coronary angioplasty. Circulation. 1987;76:125-134.
24. White CW, Chaitman B, Knudtson ML, Chisholm RJ, and the Ticlopidine Study Group. Antiplatelet agents are effective in reducing the acute ischemic complications of angioplasty but do not prevent restenosis: results from the ticlopidine trial. Coron Artery Dis. 1991;2:757-767.
25. Hirsch DR, Goldhaber SZ. The bleeding time: its potential utility among patients receiving thrombolytic therapy. Am Heart J. 1990;119:158-167.
26. Moliterno DJ, Califf RM, Anderson K, Sigmon KN, Aguirre F, Weisman HF, Topol EJ, and EPIC Study Investigators. Activated clotting time is increased during coronary interventions with platelet IIb/IIIa antagonism: results from the EPIC trial. J Am Coll Cardiol. 1994;23(suppl):106A. Abstract.
27. Mann KG, Bovill EG, Krishnaswamy S. Surface-dependent reactions in the propagation phase of blood coagulation. Ann N Y Acad Sci. 1991;614:63-75.
28. Swords NA, Mann KG. The assembly of the prothrombinase complex on adherent platelets. Arterioscler Thromb. 1993;13: 1602-1612.
29. Bauman RP, Harrington RA. Adjunct pharmacologic support during an interventional procedure. In: Roubin GS, Califf RM, O'Neill WW, Phillips HR, Stack RS, eds. Interventional Cardiovascular Medicine. Principles and Practice. New York, NY: Churchill Livingstone Inc; 1994:593-600.
30. Ellis SG, Tcheng JE, Navetta FI, Muller DWM, Weisman HF, Smith C, Anderson KM, Califf RM, Topol EJ. Safety and anti-platelet effect of murine monoclonal antibody 7E3 Fab directed against platelet glycoprotein IIb/IIIa in patients undergoing elective coronary angioplasty. Coron Artery Dis. 1993;4:167-175.