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See also:
All percutaneous coronary intervention clinical trials
All acute coronary syndrome clinical trials
All clinical trials of New P2Y12 Inhibitors
All clinical trials of cangrelor up front
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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 |
|
Studied treat. |
Control treat. |
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
Relative risks
|
Endpoint |
Events (%) |
Relative Risk |
95% CI |
Endpoint definition in the trial |
Ref |
Studied treat. |
Control treat. |
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 |
studied treat. |
control treat. |
mean diff |
Absolute risk reduction
|
Endpoint |
Events rate |
Absolute risk reduction (ARR) |
Studied treat. |
Control treat. |
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)
-
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
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Hubmed
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