最新CURE Clinical Trial Results The International Leader in 治疗的临床试验的的结果的国际领先-PPT文档.ppt
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1、Disclaimer,This slide kit presents new data to support the rationale for the use of ADP receptor antagonists for approved and unapproved indications. The slide kit has been prepared for medical and scientific purposes. It contains information on a use that is not approved by the FDA and should not b
2、e construed as an inducement to use clopidogrel for unapproved indications. Neither Sanofi-Synthelabo Inc., Bristol-Myers Squibb nor the partnership recommends the use of clopidogrel in any manner inconsistent with that described in the full prescribing information.,CURE Study Investigators. Eur Hea
3、rt J. 2000;21:2033-2041. PURSUIT Investigators. Am J Cardiol. 1999;83:1147-1151.,Rationale,Despite treatment with aspirin and heparin, the incidence of MI and CV death during hospitalization remains high, 6-8% Long term, the incidence of these events remain high at 6-8% per year The majority of pati
4、ents (80%) who enter the hospital with acute coronary syndrome (ACS) are already on aspirin therapy The negative findings of the oral GP IIb/IIIas underscores the need for alternative strategies to treat ACS,CURE Study Investigators. Eur Heart J. 2000; 21:2033-2041.,Study Objectives,Primary Evaluate
5、 the early and long-term efficacy of clopidogrel vs placebo, both given in addition to aspirin and other standard therapy in preventing ischemic complications in patients with ACS without ST-segment elevation (unstable angina or non-ST-segment elevation MI) Secondary Evaluate the safety of clopidogr
6、el in combination with ASA therapy in patients with ACS,Clopidogrel 75mg q.d. + ASA 75-325 mg q.d.* (6259 patients),Placebo + ASA 75-325 mg q.d.* (6303 patients),Day 1,6 m. Visit,9 m. Visit,12 m. or Final Visit,3 m. Visit,Discharge Visit,1 m. Visit,Patients with Acute Coronary Syndrome,(unstable ang
7、ina or non-ST-segment elevation MI),R,Placebo loading dose,R = Randomization * In combination with other standard therapy,The CURE Trial Investigators. N Engl J Med. 2001;345:494-502.,Study Design,3 months double-blind treatment 12 months,Clopidogrel 300 mg loading dose,1 CURE Study Protocol (Data o
8、n file, Sanofi-Synthelabo, Inc.) 2 CURE Study Investigators. Eur Heart J. 2000; 21:2033-2041.,Key Inclusion Criteria,Age 21 years1 Suspected UA or NSTEMI (no ST 1.0 mm)2 Presentation 24 hours after onset of symptoms2 ECG changes compatible with ischemia or elevated cardiac enzymes or troponin I or T
9、 2 x ULN2,1 CURE Study Investigators. Eur Heart J. 2000; 21:2033-2041. 2 CURE Study Protocol (Data on file, Sanofi-Synthelabo, Inc.),Key Exclusion Criteria,NYHA Class IV heart failure1 Uncontrolled hypertension2 Current use of anticoagulants1, clopidogrel, ticlopidine, or NSAIDS2, or GP IIb/IIIa inh
10、ibitor within 3 days1 PCI or CABG within 3 months1 History of severe thrombocytopenia or neutropenia2 At high risk for bleeding1 Contraindications to antithrombotic or antiplatelet therapy1,Outcome Definitions,MI: At least two of the following criteria: chest pain, ECG changes, elevation of cardiac
11、markers or enzymes (Troponin, CK, CK-MB) Stroke: Neurological deficit 24 hrs (CT/MRI encouraged) CV Death: Excludes any death for which there was no clearly documented non-CV cause Refractory Ischemia: In-hosp: recurrent ischemia on max med Rx + ECG changes + intervention 1 day After discharge: Reho
12、sp for UA with ECG changes Severe Ischemia: Changes similar to in-hospital refractory ischemia, but no intervention Recurrent Angina: All other ischemic chest pain in hospital,The CURE Trial Investigators. N Engl J Med. 2001;345:494-502.,Efficacy Analyses,First Primary End Point First occurrence of
13、any component of the cluster of: Myocardial Infarction Stroke (ischemic, hemorrhagic, or of uncertain type) Cardiovascular death Second Primary End Point First occurrence of any component of the cluster of: Myocardial Infarction Stroke (ischemic, hemorrhagic, or of uncertain type) Cardiovascular dea
14、th Refractory ischemia,The CURE Trial Investigators. N Engl J Med. 2001;345:494-502.,Age (mean) 64.2 64.2 Mean time from pain onset to randomization (hrs) 14.1 14.2 Mean heart rate (beats/min) 73.0 73.2 Mean systolic BP (mm Hg) 134.1 134.4 Female (%) 38.3 38.7 Diagnosis at Entry Unstable Angina (%)
15、74.9 74.9 NonST-segment elevation MI (%) 25.1 25.1 ECG abnormalities (%) 93.9 93.7,Placebo N = 6303,Clopidogrel N = 6259,Baseline Characteristics,The CURE Trial Investigators. N Engl J Med. 2001;345:494-502.,History of MI 32.0 32.4 CABG Surgery/PTCA 18.1 17.7 Stroke 3.7 4.4 Heart Failure 7.8 7.4 Hyp
16、ertension 57.8 59.9 Diabetes 22.8 22.4 Current or former smoker 60.9 60.6,Placebo N = 6303 (%),Clopidogrel N = 6259 (%),The CURE Trial Investigators. N Engl J Med. 2001;345:494-502.,Patient History,History Abnormal ECG 93.9 93.7 ST-segment Dep 1 mm 42.0 42.2 ST-segment elevation 1 mm 3.2 3.2 Major T
17、-wave inversion 25.9 25.4 Other T-wave inversion 11.3 11.5 Other abnormalities 10.9 10.7,Placebo (%),Clopidogrel (%),The CURE Trial Investigators. N Engl J Med. 2001;345:494-502.,ECG Abnormality Type,Clopidogrel + ASA*,3,6,9,Placebo + ASA*,Months of Follow-Up,11.4%,9.3%,20% RRR P 0.001 N = 12,562,0,
18、12,* In combination with standard therapy The CURE Trial Investigators. N Engl J Med. 2001;345:494-502.,Primary End Point - MI/Stroke/CV Death,Clopidogrel + ASA*,10,20,30,Placebo + ASA*,Days of Follow-Up,0,21% RRR P = 0.003 N = 12,562,* In combination with standard therapy The CURE Trial Investigato
19、rs. N Engl J Med. 2001;345:494-502.,MI/Stroke/CV Death within 30 Days,CV death, MI, stroke (Primary 11.4% 9.3% 20% 0.001 end point) MI 6.7% 5.2% 23% Stroke 1.4% 1.2% 14% CV death 5.5% 5.1% 7%,Relative Risk Reduction,P value,Outcome,Placebo + ASA* N = 6303,Clopidogrel + ASA* N = 6259,* In combination
20、 with standard therapy The CURE Trial Investigators. N Engl J Med. 2001;345:494-502.,Main Efficacy Results - Primary Endpoint,RRR,P value,End Point,Placebo + ASA*,Clopidogrel + ASA*,Main Efficacy Results - Second Primary End Point,* In combination with standard therapy * Not significant Heart failur
21、e was a secondary end point,Second Primary End Point 18.8% 16.5% 14% 0.001 Refractory Ischemia 9.3% 8.7% 7% NS* Refractory Ischemia in hospital 2.0% 1.4% 32% P 0.001 Refractory Ischemia after discharge 7.6% 7.6% 1% NS* Severe Ischemia 3.8% 2.8% 26% P = 0.003 Recurrent Ischemia 22.9% 20.9% 9% P = 0.0
22、1 Heart Failure 4.4% 3.7% 18% P = 0.03,The CURE Trial Investigators. N Engl J Med. 2001;345:494-502.,Overall 12562 9.3 11.4 Associated MI 3283 11.3 13.7 No associated MI 9279 8.6 10.6 Male sex 7726 9.1 11.9 Female sex 4836 9.5 10.7 65 yr old 6354 5.4 7.6 65 yr old 6208 13.3 15.3 ST-segment deviation
23、 6275 11.5 14.3 No ST-segment deviation 6287 7.0 8.6 Enzymes elevated at entry 3176 10.7 13.0 Enzymes not elevated at entry 9386 8.8 10.9 Diabetes 2840 14.2 16.7 No diabetes 9722 7.9 9.9 Low risk 4187 5.1 6.7 Intermediate risk 4185 6.5 9.4 High risk 4184 16.3 18.0 History of revascularization 2246 8
24、.4 14.4 No history of revascularization 10316 9.5 10.7 Revascularization after randomization 4577 11.5 13.9 No revascularization after randomization 7985 8.1 10.0,Placebo + ASA*,Characteristic,No. of Patients,Clopidogrel + ASA*,Percentage of Patients with Event,Placebo Better,Clopidogrel Better,Rela
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