CHAMPION-PLATFORM trial

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Systematic review and meta-analysis

This trial is included in the following systematic reviews and meta-analyses:

percutaneous coronary intervention - antithrombotics - all type of patients

acute coronary syndrome - New P2Y12 Inhibitors - all type of patients

TRA-PCI, 2009 - SCH 530348 vs placebo

NAPLES (Tavano), 2009 - bivalirudin vs actionated heparin plus tirofiban

PLATO, 2009 - ticagrelor vs clopidogrel (on top aspirin)

CHAMPION-PCI, 2009 - cangrelor up front vs clopidogrel up front

CHAMPION-PLATFORM, 2009 - cangrelor up front vs delayed clopidogrel

ERASE-MI, 2009 - elinogrel vs placebo

ISAR-REACT 3, 2008 - bivalirudin vs UFH

HORIZONS-AMI (Stone), 2008 - bivalirudin vs heparin + GP2b3a inhibitors

DISPERSE-2 (90mg), 2007 - ticagrelor vs clopidogrel (on top aspirin)

TRITON-TIMI 38, 2007 - prasugrel vs clopidogrel (on top aspirin)

STEEPLE, 2006 - enoxaparin vs UFH

ACUITY (Stone) (bivalirudin alone), 2006 - bivalirudin vs heparin + GP2b3a inhibitors

JUMBO-TIMI 26, 2005 - prasugrel vs clopidogrel

REPLACE-1, 2004 - bivalirudin vs UFH

Natarajan (without antiGp2b3a), 2003 - Dalteparin vs UFH

REPLACE-2, 2003 - bivalirudin vs hepatin + anti Gp2b3a

CRUISE, 2003 - Enoxaparin vs UFH

Natarajan (+ antiGp2b3a), 2003 - Dalteparin vs UFH + anti Gp2b3a

Petronio, 2002 - Abciximab vs placebo

Tamburino, 2002 - Abciximab vs placebo

Kleiman, 2002 - bivalirudin + eptifibatide vs heparin + eptifibatide

CADILLAC, 2002 - Abciximab vs placebo

Galeote, 2001 - Enoxaparin vs UFH

Drozd, 2001 - Enoxaparin vs UFH

Treatments

Studied treatment	cangrelor up front (cangrelor during PCI followed by 600 mg of clopidogrel) cangrelor (in a bolus of 30 �g per kilogram of body weight and an infusion of 4 �g per kilogram per minute) for the duration of the PCI procedure, with a minimum infusion duration of 2 hours and a maximum of 4 hours
Control treatment	delayed clopidogrel (placebo during PCI followed by 600 mg of clopidogrel) placebo bolus and infusion for the duration of the PCI procedure
Remarks	cangrelor up front vs delayed clopidogrel

Patients

Patients	patients with acute coronary syndrome undergoing percutaneous coronary intervention
Inclusion criteria	age of at least 18 years, diagnostic coronary angiography revealing at least one atherosclerotic lesion amenable to PCI with or without stent implantation, and evidence of either myocardial infarction without ST-segment elevation or unstable angina
Remarks	Patients with stable angina were initially eligible at the beginning of the trial before a protocol amendment

Method and design

Randomized effectives	2693 / 2669 (studied vs. control)
Design	Parallel groups
Blinding	double blind
Follow-up duration	48 h
Number of centre	218
Geographic area	18 countries
Primary endpoint	death, MI, ischemia-driven revascularization

Results

Endpoints and data reported in the trial's publication(s)

Endpoint	Events (%)		Relative Risk	95% CI
Endpoint	Studied treat.	Control treat.	Relative Risk	95% CI
Death, MI, ischemia-driven revascularization	187 / 2691 (6,9%)	213 / 2664 (8,0%)	0,87	[0,72;1,05]
Myocardial infarction	177 / 2691 (6,6%)	192 / 2664 (7,2%)	0,91	[0,75;1,11]
Ischemia-driven revascularization	19 / 2691 (0,7%)	26 / 2664 (1,0%)	0,72	[0,40;1,30]
Death from any cause	8 / 2691 (0,3%)	19 / 2664 (0,7%)	0,42	[0,18;0,95]
Stroke	7 / 2691 (0,3%)	6 / 2664 (0,2%)	1,15	[0,39;3,43]
Stent thrombosis	5 / 2691 (0,2%)	16 / 2664 (0,6%)	0,31	[0,11;0,84]
Q-wave myocardial infarction	4 / 2691 (0,1%)	9 / 2664 (0,3%)	0,44	[0,14;1,43]
Death, Q-wave myocardial infarction, ischemia-driven revascularization	25 / 2691 (0,9%)	44 / 2664 (1,7%)	0,56	[0,35;0,92]
	Not calculable (data not available)
Death, Q-wave myocardial infarction, or stent thrombosis	15 / 2691 (0,6%)	36 / 2664 (1,4%)	0,41	[0,23;0,75]

Endpoints used by the meta-analysis and data retained for this trial

Endpoint Studied treat.
n/N Control treat.
n/N Graph RR [95% CI]

stroke (fatal and non fatal)

7 / 2691
6 / 2664
classic 1,15 [0,39;3,43]

MI (fatal and non fatal)

177 / 2691
192 / 2664
0,91 [0,75;1,11] 0 2 1.0

Endpoint	Events (%)		Relative Risk	95% CI	Endpoint definition in the trial	Ref
Relative risks
Endpoint	Studied treat.	Control treat.	Relative Risk	95% CI	Endpoint definition in the trial	Ref
MI (fatal and non fatal)	177 / 2691 (6,6%)	192 / 2664 (7,2%)	0,91	[0,75;1,11]	Myocardial infarction
stroke (fatal and non fatal)	7 / 2691 (0,3%)	6 / 2664 (0,2%)	1,15	[0,39;3,43]	Stroke
The primary endpoint (if exists) appears in blod characters
Reference(s) used for data extraction:

Endpoint	Events rate		Absolute risk reduction (ARR)
Absolute risk reduction
Endpoint	Studied treat.	Control treat.	Absolute risk reduction (ARR)
MI (fatal and non fatal)	6,58%	7,21%	-6,3‰
stroke (fatal and non fatal)	2,60‰	2,25‰	0,3‰

Meta-analysis of all similar trials:

antithrombotics in percutaneous coronary intervention for all type of patients

New P2Y12 Inhibitors in acute coronary syndrome for all type of patients

Reference(s)

Trials register #

NCT00385138

Bhatt DL, Lincoff AM, Gibson CM, Stone GW, McNulty S, Montalescot G, Kleiman NS, Goodman SG, White HD, Mahaffey KW, Pollack CV Jr, Manoukian SV, Widimsky P, Chew DP, Cura F, Manukov I, Tousek F, Jafar MZ, Arneja J, Skerjanec S, Harrington RA. Intravenous Platelet Blockade with Cangrelor during PCI.. N Engl J Med 2009 Nov 15;:
Pubmed | Hubmed | Fulltext

CHAMPION-PLATFORM study, 2009