The available evidence demonstrates that the use of clopidogrel plus aspirin in people at high risk of cardiovascular disease and people with established cardiovascular disease without a coronary stent is associated with a reduction in the risk of myocardial infa rct ion and ischaemic stroke , and an increased risk of major and minor bleeding compared with aspirin alone .
According to GRADE criteria , the quality of evidence was moderate for all outcomes except all-cause mortality ( low quality evidence ) and adverse events ( very low quality evidence )
BACKGROUND Aspirin is the prophylactic antiplatelet drug of choice for people with cardiovascular disease .
Adding a second antiplatelet drug to aspirin may produce additional benefit for people at high risk and people with established cardiovascular disease .
This is an up date to a previously published review from 2011 .
OBJECTIVES To review the benefit and harm of adding clopidogrel to aspirin therapy for preventing cardiovascular events in people who have coronary disease , ischaemic cerebrovascular disease , peripheral arterial disease , or were at high risk of atherothrombotic disease , but did not have a coronary stent .
Comparison of antiplatelet effect and tolerability of clopidogrel resinate with clopidogrel bisulfate in patients with coronary heart disease (CHD) or CHD-equivalent risks: a phase IV, prospective, double-dummy, parallel-group, 4-week noninferiority trial.
BACKGROUND Clopidogrel resinate is a resinate complex of (+)-clopidogrel optical isomer , wherein the (+)-clopidogrel isomer binds to a water-soluble cation exchange resin via sulfonic acid groups . It was approved by the Korean Food and Drug Administration on the basis of a Phase I study that demonstrated the bioequivalence of clopidogrel resinate and clopidogrel bisulfate . However , there are no available data regarding efficacy and tolerability in patients with vascular disease . OBJECTIVE The goal of this study was to investigate the antiplatelet efficacy and tolerability of clopidogrel resinate in patients with coronary heart disease ( CHD ) or CHD-equivalent risks . METHODS This study was a Phase IV , r and omized , double-blind , double-dummy , parallel-group , noninferiority trial . We prospect ively recruited patients in 10 centers between March 2008 and July 2008 . Patients who had documented CHD or CHD-equivalent risks were r and omly assigned to 1 of 3 groups : group A , aspirin ( 100 mg ) + clopidogrel bisulfate placebo + clopidogrel resinate placebo ; group B , aspirin ( 100 mg ) + clopidogrel bisulfate placebo + clopidogrel resinate ( 75 mg ) ; or group C , aspirin ( 100 mg ) + clopidogrel bisulfate ( 75 mg ) + clopidogrel resinate placebo . The primary outcome was the percent P2Y(12 ) inhibition after medication , assessed by using a point-of-care assay . If the 1-sided 90 % upper confidence limit for the difference was less than the prespecified delta value ( -5.7 ) , clopidogrel resinate would be considered noninferior to clopidogrel bisulfate . The secondary outcome , the prevalence of adverse events ( AEs ) associated with study medications , was assessed at each visit by direct interview . RESULTS A total of 314 patients ( mean [ SD ] age , 62.2 [ 9.0 ] years ; male 63.7 % ; weight , 67.3 [ 13.6 ] kg [ range , 45 - 102 kg ] ; all Asian ) were enrolled , and 287 patients finished the study ( group A , n = 97 ; group B , n = 90 ; and group C , n = 100 ) . Eight patients took no study medications and were excluded from the tolerability and efficacy analyses . Nineteen patients discontinued the study because of protocol violation ( n = 15 ) , adverse events ( n = 3 ) , or voluntary withdrawal ( n = 1 ) and were excluded from the efficacy analysis . There were no significant differences in baseline clinical characteristics among the groups except for the frequency of a history of CHD ( group A , 85.4 % ; group B , 73.0 % ; and group C , 88.3 % ; P = 0.01 ) . Patients treated with either type of clopidogrel showed significant inhibition ( mean [ SD ] ) of P2Y(12 ) ( group A , -5.9 % [ 15.1 % ] ; group B , 23.4 % [ 21.9 % ] ; and group C , 19.5 % [ 23.8 % ] ; P < 0.001 ) . Differences between clopidogrel resinate and clopidogrel bisulfate in the inhibition of P2Y(12 ) did not exceed the predetermined value for inferiority ( P for noninferiority , 0.02 ; 90 % CI , -0.9 to 10.3 ) . In the tolerability analysis , there was no mortality during the study period and no significant differences between groups in the frequency of AEs and serious AEs ( AEs : group A , 33.0 % ; group B , 26.0 % ; and group C , 23.3 % [ P = 0.27 ] ; serious AEs : group A , 1.0 % ; group B , 3.0 % ; and group C , 1.0 % [ P = 0.42 ] ) . One patient in group B underwent coronary stent implantation for treatment of stable angina . CONCLUSIONS In this small , selected Asian patient population , differences in the platelet inhibition efficacies of clopidogrel resinate and clopidogrel bisulfate did not exceed the predetermined limits for noninferiority . The differences in tolerability between the 2 drugs did not reach statistical significance
The available evidence demonstrates that the use of clopidogrel plus aspirin in people at high risk of cardiovascular disease and people with established cardiovascular disease without a coronary stent is associated with a reduction in the risk of myocardial infa rct ion and ischaemic stroke , and an increased risk of major and minor bleeding compared with aspirin alone .
According to GRADE criteria , the quality of evidence was moderate for all outcomes except all-cause mortality ( low quality evidence ) and adverse events ( very low quality evidence )
BACKGROUND Aspirin is the prophylactic antiplatelet drug of choice for people with cardiovascular disease .
Adding a second antiplatelet drug to aspirin may produce additional benefit for people at high risk and people with established cardiovascular disease .
This is an up date to a previously published review from 2011 .
OBJECTIVES To review the benefit and harm of adding clopidogrel to aspirin therapy for preventing cardiovascular events in people who have coronary disease , ischaemic cerebrovascular disease , peripheral arterial disease , or were at high risk of atherothrombotic disease , but did not have a coronary stent .