The Clopidogrel in Unstable angina to prevent Recurrent Events (CURE) trial programme: Rationale, design and baseline characteristics including a meta-analysis of the effects of thienopyridines in vascular disease

S. Yusuf; S. Mehta; S. Anand; A. Avezum; N. Awan; M. Bertrand; M. Blumenthal; J. Bouthier; A. Budaj; L. Ceremuzynski; S. Chrolavicius; J. Col; P. Commerford; R. Diaz; M. Flather; K. Fox; M. G. Franzosi; C. Gaudin; B. Gersh; W. Grossman; D. Halon; T. Hess; D. Hunt; C. Joyner; N. Karatzas; M. Keltai; N. Khurmi; S. Kopecky; B. Lewis; A. Maggioni; K. Malmberg; T. Mocceti; J. Morais; E. Paolasso; R. Peters; L. Piegas; A. Pipilis; M. A. Ramos-Corrales; H. J. Rupprecht; L. Ryden; E. Sitkei; M. Sotty; G. Tognoni; V. Valentin; J. Varigos; P. Widimsky; T. Wittlinger; J. Pogue; I. Copland; B. Cracknell; C. Demers; J. Eikelboom; K. Hall; J. Keys; M. McQueen; P. Montague; B. Morris; S. Ounpuu; C. Wright; V. Yacyshyn; F. Zhao; J. Varigos; P. J. Commerford; G. Wyse; J. Cairns; R. Hart; J. Hirsh; M. Gent; T. Ryan; J. Wittes; P. Auger; D. C.G. Basart; Y. Chan; H. De Raedt; M. Den Hartoog; M. Galli; J. Garcia-Guerrero; J. F. Marquis; F. Mauri; B. Mayosi; M. Natarajan; M. Nieminen; J. Norris; A. Panju; R. J. Peters; J. Renkin; C. Rihal; P. Szymanski; W. Wasek; G. Allende; J. O. Bono; A. Caccavo; A. A. Fernandez; J. J. Fuselli; A. J. Gambarte; R. A. Ahuad Guerrero; E. G. Hasbani; A. Sosa Liprandi

doi:10.1053/euhj.2000.2474

The Clopidogrel in Unstable angina to prevent Recurrent Events (CURE) trial programme: Rationale, design and baseline characteristics including a meta-analysis of the effects of thienopyridines in vascular disease

S. Yusuf, S. Mehta, S. Anand, A. Avezum, N. Awan, M. Bertrand, M. Blumenthal, J. Bouthier, A. Budaj, L. Ceremuzynski, S. Chrolavicius, J. Col, P. Commerford, R. Diaz, M. Flather, K. Fox, M. G. Franzosi, C. Gaudin, B. Gersh, W. GrossmanD. Halon, T. Hess, D. Hunt, C. Joyner, N. Karatzas, M. Keltai, N. Khurmi, S. Kopecky, B. Lewis, A. Maggioni, K. Malmberg, T. Mocceti, J. Morais, E. Paolasso, R. Peters, L. Piegas, A. Pipilis, M. A. Ramos-Corrales, H. J. Rupprecht, L. Ryden, E. Sitkei, M. Sotty, G. Tognoni, V. Valentin, J. Varigos, P. Widimsky, T. Wittlinger, J. Pogue, I. Copland, B. Cracknell, C. Demers, J. Eikelboom, K. Hall, J. Keys, M. McQueen, P. Montague, B. Morris, S. Ounpuu, C. Wright, V. Yacyshyn, F. Zhao, J. Varigos, P. J. Commerford, G. Wyse, J. Cairns, R. Hart, J. Hirsh, M. Gent, T. Ryan, J. Wittes, P. Auger, D. C.G. Basart, Y. Chan, H. De Raedt, M. Den Hartoog, M. Galli, J. Garcia-Guerrero, J. F. Marquis, F. Mauri, B. Mayosi, M. Natarajan, M. Nieminen, J. Norris, A. Panju, R. J. Peters, J. Renkin, C. Rihal, P. Szymanski, W. Wasek, G. Allende, J. O. Bono, A. Caccavo, A. A. Fernandez, J. J. Fuselli, A. J. Gambarte, R. A. Ahuad Guerrero, E. G. Hasbani, A. Sosa Liprandi

Cardiovascular Medicine

Research output: Contribution to journal › Article › peer-review

277 Scopus citations

Abstract

Background: Other than aspirin, there are few oral antithrombotic treatments with proven efficacy in patients with acute coronary syndrome. In this report, we present the rationale, design and baseline characteristics of the Clopidogrel in Unstable angina to prevent Recurrent ischaemic Events (CURE) trial, which includes a meta-analysis of the effects of thienopyridines in patients with vascular disease. Methods and Results: Combined data from randomized trials of thienopyrindines in patients with atherosclerotic disease demonstrated a 29% reduction in vascular events when compared with placebo/control (n=2392) (OR 0·71, 95% CI 0·58-0·86, P=0·0006) and a 10% reduction in vascular events when compared with aspirin (n=22 254) (OR 0·91, 95% C· 0·84-0·99, P=0·039). Similarly, randomized trials of aspirin plus thienopyridines in patients undergoing intracoronary stenting, demonstrated a marked benefit of aspirin plus ticlopidine in reducing death or myocardial infarction compared with aspirin alone (OR 0·23, 95% CI 0·11-0·49, P=0·0001) or aspirin plus warfarin (OR 0·51, 95% CI 0·33-0·78, P=0·002). Whether these benefits extend to the much larger population of patients with acute coronary syndrome is unknown. CURE is an international, randomized, double-blind trial, in which patients with acute coronary syndrome will be randomized to receive either a bolus dose of clopidogrel (300 mg) followed by 75 mg per day for 3-12 months, or matching placebo. Both groups will receive aspirin. The co-primary efficacy end-points of CURE are: (1) the composite of cardiovascular death, myocardial infarction or stroke; and (2) the composite of cardiovascular death, myocardial infarction, stroke or refractory ischaemia. CURE will recruit approximately 12 500 patients with acute coronary syndrome (from 28 countries) and its power to detect moderate treatment benefits will be in the region of 80-90%, while maintaining an overall type I error (a) of 0·05. The baseline characteristics of the study population are consistent with at least a moderate risk group of patients with acute coronary syndrome. Conclusions: Randomized trials of thienopyridines in patients with vascular disease demonstrate that thienopyridines are effective in reducing vascular events when compared with placebo/control or aspirin, as well as when used in combination with aspirin in patients undergoing intracoronary stent implantation. The CURE trial is a large international study to determine if acute and long-term treatment with the combination of clopidogrel and aspirin is superior to aspirin alone in patients with acute coronary syndrome. (C) 2000 The European Society of Cardiology.

Original language	English (US)
Pages (from-to)	2033-2041
Number of pages	9
Journal	European heart journal
Volume	21
Issue number	24
DOIs	https://doi.org/10.1053/euhj.2000.2474
State	Published - 2000

Keywords

Clinical trial
Meta-analysis
Thienopyridines
Unstable angina

ASJC Scopus subject areas

Cardiology and Cardiovascular Medicine

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10.1053/euhj.2000.2474

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Yusuf, S., Mehta, S., Anand, S., Avezum, A., Awan, N., Bertrand, M., Blumenthal, M., Bouthier, J., Budaj, A., Ceremuzynski, L., Chrolavicius, S., Col, J., Commerford, P., Diaz, R., Flather, M., Fox, K., Franzosi, M. G., Gaudin, C., Gersh, B., ... Sosa Liprandi, A. (2000). The Clopidogrel in Unstable angina to prevent Recurrent Events (CURE) trial programme: Rationale, design and baseline characteristics including a meta-analysis of the effects of thienopyridines in vascular disease. European heart journal, 21(24), 2033-2041. https://doi.org/10.1053/euhj.2000.2474

The Clopidogrel in Unstable angina to prevent Recurrent Events (CURE) trial programme: Rationale, design and baseline characteristics including a meta-analysis of the effects of thienopyridines in vascular disease. / Yusuf, S.; Mehta, S.; Anand, S. et al.
In: European heart journal, Vol. 21, No. 24, 2000, p. 2033-2041.

Research output: Contribution to journal › Article › peer-review

Yusuf, S, Mehta, S, Anand, S, Avezum, A, Awan, N, Bertrand, M, Blumenthal, M, Bouthier, J, Budaj, A, Ceremuzynski, L, Chrolavicius, S, Col, J, Commerford, P, Diaz, R, Flather, M, Fox, K, Franzosi, MG, Gaudin, C, Gersh, B, Grossman, W, Halon, D, Hess, T, Hunt, D, Joyner, C, Karatzas, N, Keltai, M, Khurmi, N, Kopecky, S, Lewis, B, Maggioni, A, Malmberg, K, Mocceti, T, Morais, J, Paolasso, E, Peters, R, Piegas, L, Pipilis, A, Ramos-Corrales, MA, Rupprecht, HJ, Ryden, L, Sitkei, E, Sotty, M, Tognoni, G, Valentin, V, Varigos, J, Widimsky, P, Wittlinger, T, Pogue, J, Copland, I, Cracknell, B, Demers, C, Eikelboom, J, Hall, K, Keys, J, McQueen, M, Montague, P, Morris, B, Ounpuu, S, Wright, C, Yacyshyn, V, Zhao, F, Varigos, J, Commerford, PJ, Wyse, G, Cairns, J, Hart, R, Hirsh, J, Gent, M, Ryan, T, Wittes, J, Auger, P, Basart, DCG, Chan, Y, De Raedt, H, Den Hartoog, M, Galli, M, Garcia-Guerrero, J, Marquis, JF, Mauri, F, Mayosi, B, Natarajan, M, Nieminen, M, Norris, J, Panju, A, Peters, RJ, Renkin, J, Rihal, C, Szymanski, P, Wasek, W, Allende, G, Bono, JO, Caccavo, A, Fernandez, AA, Fuselli, JJ, Gambarte, AJ, Ahuad Guerrero, RA, Hasbani, EG & Sosa Liprandi, A 2000, 'The Clopidogrel in Unstable angina to prevent Recurrent Events (CURE) trial programme: Rationale, design and baseline characteristics including a meta-analysis of the effects of thienopyridines in vascular disease', European heart journal, vol. 21, no. 24, pp. 2033-2041. https://doi.org/10.1053/euhj.2000.2474

@article{2cc104f146d047e0bae7335e821e3ce4,

title = "The Clopidogrel in Unstable angina to prevent Recurrent Events (CURE) trial programme: Rationale, design and baseline characteristics including a meta-analysis of the effects of thienopyridines in vascular disease",

abstract = "Background: Other than aspirin, there are few oral antithrombotic treatments with proven efficacy in patients with acute coronary syndrome. In this report, we present the rationale, design and baseline characteristics of the Clopidogrel in Unstable angina to prevent Recurrent ischaemic Events (CURE) trial, which includes a meta-analysis of the effects of thienopyridines in patients with vascular disease. Methods and Results: Combined data from randomized trials of thienopyrindines in patients with atherosclerotic disease demonstrated a 29% reduction in vascular events when compared with placebo/control (n=2392) (OR 0·71, 95% CI 0·58-0·86, P=0·0006) and a 10% reduction in vascular events when compared with aspirin (n=22 254) (OR 0·91, 95% C· 0·84-0·99, P=0·039). Similarly, randomized trials of aspirin plus thienopyridines in patients undergoing intracoronary stenting, demonstrated a marked benefit of aspirin plus ticlopidine in reducing death or myocardial infarction compared with aspirin alone (OR 0·23, 95% CI 0·11-0·49, P=0·0001) or aspirin plus warfarin (OR 0·51, 95% CI 0·33-0·78, P=0·002). Whether these benefits extend to the much larger population of patients with acute coronary syndrome is unknown. CURE is an international, randomized, double-blind trial, in which patients with acute coronary syndrome will be randomized to receive either a bolus dose of clopidogrel (300 mg) followed by 75 mg per day for 3-12 months, or matching placebo. Both groups will receive aspirin. The co-primary efficacy end-points of CURE are: (1) the composite of cardiovascular death, myocardial infarction or stroke; and (2) the composite of cardiovascular death, myocardial infarction, stroke or refractory ischaemia. CURE will recruit approximately 12 500 patients with acute coronary syndrome (from 28 countries) and its power to detect moderate treatment benefits will be in the region of 80-90%, while maintaining an overall type I error (a) of 0·05. The baseline characteristics of the study population are consistent with at least a moderate risk group of patients with acute coronary syndrome. Conclusions: Randomized trials of thienopyridines in patients with vascular disease demonstrate that thienopyridines are effective in reducing vascular events when compared with placebo/control or aspirin, as well as when used in combination with aspirin in patients undergoing intracoronary stent implantation. The CURE trial is a large international study to determine if acute and long-term treatment with the combination of clopidogrel and aspirin is superior to aspirin alone in patients with acute coronary syndrome. (C) 2000 The European Society of Cardiology.",

keywords = "Clinical trial, Meta-analysis, Thienopyridines, Unstable angina",

author = "S. Yusuf and S. Mehta and S. Anand and A. Avezum and N. Awan and M. Bertrand and M. Blumenthal and J. Bouthier and A. Budaj and L. Ceremuzynski and S. Chrolavicius and J. Col and P. Commerford and R. Diaz and M. Flather and K. Fox and Franzosi, {M. G.} and C. Gaudin and B. Gersh and W. Grossman and D. Halon and T. Hess and D. Hunt and C. Joyner and N. Karatzas and M. Keltai and N. Khurmi and S. Kopecky and B. Lewis and A. Maggioni and K. Malmberg and T. Mocceti and J. Morais and E. Paolasso and R. Peters and L. Piegas and A. Pipilis and Ramos-Corrales, {M. A.} and Rupprecht, {H. J.} and L. Ryden and E. Sitkei and M. Sotty and G. Tognoni and V. Valentin and J. Varigos and P. Widimsky and T. Wittlinger and J. Pogue and I. Copland and B. Cracknell and C. Demers and J. Eikelboom and K. Hall and J. Keys and M. McQueen and P. Montague and B. Morris and S. Ounpuu and C. Wright and V. Yacyshyn and F. Zhao and J. Varigos and Commerford, {P. J.} and G. Wyse and J. Cairns and R. Hart and J. Hirsh and M. Gent and T. Ryan and J. Wittes and P. Auger and Basart, {D. C.G.} and Y. Chan and {De Raedt}, H. and {Den Hartoog}, M. and M. Galli and J. Garcia-Guerrero and Marquis, {J. F.} and F. Mauri and B. Mayosi and M. Natarajan and M. Nieminen and J. Norris and A. Panju and Peters, {R. J.} and J. Renkin and C. Rihal and P. Szymanski and W. Wasek and G. Allende and Bono, {J. O.} and A. Caccavo and Fernandez, {A. A.} and Fuselli, {J. J.} and Gambarte, {A. J.} and {Ahuad Guerrero}, {R. A.} and Hasbani, {E. G.} and {Sosa Liprandi}, A.",

year = "2000",

doi = "10.1053/euhj.2000.2474",

language = "English (US)",

volume = "21",

pages = "2033--2041",

journal = "European heart journal",

issn = "0195-668X",

publisher = "Oxford University Press",

number = "24",

}

TY - JOUR

T1 - The Clopidogrel in Unstable angina to prevent Recurrent Events (CURE) trial programme

T2 - Rationale, design and baseline characteristics including a meta-analysis of the effects of thienopyridines in vascular disease

AU - Yusuf, S.

AU - Mehta, S.

AU - Anand, S.

AU - Avezum, A.

AU - Awan, N.

AU - Bertrand, M.

AU - Blumenthal, M.

AU - Bouthier, J.

AU - Budaj, A.

AU - Ceremuzynski, L.

AU - Chrolavicius, S.

AU - Col, J.

AU - Commerford, P.

AU - Diaz, R.

AU - Flather, M.

AU - Fox, K.

AU - Franzosi, M. G.

AU - Gaudin, C.

AU - Gersh, B.

AU - Grossman, W.

AU - Halon, D.

AU - Hess, T.

AU - Hunt, D.

AU - Joyner, C.

AU - Karatzas, N.

AU - Keltai, M.

AU - Khurmi, N.

AU - Kopecky, S.

AU - Lewis, B.

AU - Maggioni, A.

AU - Malmberg, K.

AU - Mocceti, T.

AU - Morais, J.

AU - Paolasso, E.

AU - Peters, R.

AU - Piegas, L.

AU - Pipilis, A.

AU - Ramos-Corrales, M. A.

AU - Rupprecht, H. J.

AU - Ryden, L.

AU - Sitkei, E.

AU - Sotty, M.

AU - Tognoni, G.

AU - Valentin, V.

AU - Varigos, J.

AU - Widimsky, P.

AU - Wittlinger, T.

AU - Pogue, J.

AU - Copland, I.

AU - Cracknell, B.

AU - Demers, C.

AU - Eikelboom, J.

AU - Hall, K.

AU - Keys, J.

AU - McQueen, M.

AU - Montague, P.

AU - Morris, B.

AU - Ounpuu, S.

AU - Wright, C.

AU - Yacyshyn, V.

AU - Zhao, F.

AU - Varigos, J.

AU - Commerford, P. J.

AU - Wyse, G.

AU - Cairns, J.

AU - Hart, R.

AU - Hirsh, J.

AU - Gent, M.

AU - Ryan, T.

AU - Wittes, J.

AU - Auger, P.

AU - Basart, D. C.G.

AU - Chan, Y.

AU - De Raedt, H.

AU - Den Hartoog, M.

AU - Galli, M.

AU - Garcia-Guerrero, J.

AU - Marquis, J. F.

AU - Mauri, F.

AU - Mayosi, B.

AU - Natarajan, M.

AU - Nieminen, M.

AU - Norris, J.

AU - Panju, A.

AU - Peters, R. J.

AU - Renkin, J.

AU - Rihal, C.

AU - Szymanski, P.

AU - Wasek, W.

AU - Allende, G.

AU - Bono, J. O.

AU - Caccavo, A.

AU - Fernandez, A. A.

AU - Fuselli, J. J.

AU - Gambarte, A. J.

AU - Ahuad Guerrero, R. A.

AU - Hasbani, E. G.

AU - Sosa Liprandi, A.

PY - 2000

Y1 - 2000

N2 - Background: Other than aspirin, there are few oral antithrombotic treatments with proven efficacy in patients with acute coronary syndrome. In this report, we present the rationale, design and baseline characteristics of the Clopidogrel in Unstable angina to prevent Recurrent ischaemic Events (CURE) trial, which includes a meta-analysis of the effects of thienopyridines in patients with vascular disease. Methods and Results: Combined data from randomized trials of thienopyrindines in patients with atherosclerotic disease demonstrated a 29% reduction in vascular events when compared with placebo/control (n=2392) (OR 0·71, 95% CI 0·58-0·86, P=0·0006) and a 10% reduction in vascular events when compared with aspirin (n=22 254) (OR 0·91, 95% C· 0·84-0·99, P=0·039). Similarly, randomized trials of aspirin plus thienopyridines in patients undergoing intracoronary stenting, demonstrated a marked benefit of aspirin plus ticlopidine in reducing death or myocardial infarction compared with aspirin alone (OR 0·23, 95% CI 0·11-0·49, P=0·0001) or aspirin plus warfarin (OR 0·51, 95% CI 0·33-0·78, P=0·002). Whether these benefits extend to the much larger population of patients with acute coronary syndrome is unknown. CURE is an international, randomized, double-blind trial, in which patients with acute coronary syndrome will be randomized to receive either a bolus dose of clopidogrel (300 mg) followed by 75 mg per day for 3-12 months, or matching placebo. Both groups will receive aspirin. The co-primary efficacy end-points of CURE are: (1) the composite of cardiovascular death, myocardial infarction or stroke; and (2) the composite of cardiovascular death, myocardial infarction, stroke or refractory ischaemia. CURE will recruit approximately 12 500 patients with acute coronary syndrome (from 28 countries) and its power to detect moderate treatment benefits will be in the region of 80-90%, while maintaining an overall type I error (a) of 0·05. The baseline characteristics of the study population are consistent with at least a moderate risk group of patients with acute coronary syndrome. Conclusions: Randomized trials of thienopyridines in patients with vascular disease demonstrate that thienopyridines are effective in reducing vascular events when compared with placebo/control or aspirin, as well as when used in combination with aspirin in patients undergoing intracoronary stent implantation. The CURE trial is a large international study to determine if acute and long-term treatment with the combination of clopidogrel and aspirin is superior to aspirin alone in patients with acute coronary syndrome. (C) 2000 The European Society of Cardiology.

AB - Background: Other than aspirin, there are few oral antithrombotic treatments with proven efficacy in patients with acute coronary syndrome. In this report, we present the rationale, design and baseline characteristics of the Clopidogrel in Unstable angina to prevent Recurrent ischaemic Events (CURE) trial, which includes a meta-analysis of the effects of thienopyridines in patients with vascular disease. Methods and Results: Combined data from randomized trials of thienopyrindines in patients with atherosclerotic disease demonstrated a 29% reduction in vascular events when compared with placebo/control (n=2392) (OR 0·71, 95% CI 0·58-0·86, P=0·0006) and a 10% reduction in vascular events when compared with aspirin (n=22 254) (OR 0·91, 95% C· 0·84-0·99, P=0·039). Similarly, randomized trials of aspirin plus thienopyridines in patients undergoing intracoronary stenting, demonstrated a marked benefit of aspirin plus ticlopidine in reducing death or myocardial infarction compared with aspirin alone (OR 0·23, 95% CI 0·11-0·49, P=0·0001) or aspirin plus warfarin (OR 0·51, 95% CI 0·33-0·78, P=0·002). Whether these benefits extend to the much larger population of patients with acute coronary syndrome is unknown. CURE is an international, randomized, double-blind trial, in which patients with acute coronary syndrome will be randomized to receive either a bolus dose of clopidogrel (300 mg) followed by 75 mg per day for 3-12 months, or matching placebo. Both groups will receive aspirin. The co-primary efficacy end-points of CURE are: (1) the composite of cardiovascular death, myocardial infarction or stroke; and (2) the composite of cardiovascular death, myocardial infarction, stroke or refractory ischaemia. CURE will recruit approximately 12 500 patients with acute coronary syndrome (from 28 countries) and its power to detect moderate treatment benefits will be in the region of 80-90%, while maintaining an overall type I error (a) of 0·05. The baseline characteristics of the study population are consistent with at least a moderate risk group of patients with acute coronary syndrome. Conclusions: Randomized trials of thienopyridines in patients with vascular disease demonstrate that thienopyridines are effective in reducing vascular events when compared with placebo/control or aspirin, as well as when used in combination with aspirin in patients undergoing intracoronary stent implantation. The CURE trial is a large international study to determine if acute and long-term treatment with the combination of clopidogrel and aspirin is superior to aspirin alone in patients with acute coronary syndrome. (C) 2000 The European Society of Cardiology.

KW - Clinical trial

KW - Meta-analysis

KW - Thienopyridines

KW - Unstable angina

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UR - http://www.scopus.com/inward/citedby.url?scp=17744374250&partnerID=8YFLogxK

U2 - 10.1053/euhj.2000.2474

DO - 10.1053/euhj.2000.2474

M3 - Article

C2 - 11102254

AN - SCOPUS:17744374250

SN - 0195-668X

VL - 21

SP - 2033

EP - 2041

JO - European heart journal

JF - European heart journal

IS - 24

ER -

The Clopidogrel in Unstable angina to prevent Recurrent Events (CURE) trial programme: Rationale, design and baseline characteristics including a meta-analysis of the effects of thienopyridines in vascular disease

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