PLAVIX with Aspirin
Proven Efficacy with Aspirin Up to 1 Year1
CURE*–12,562 UA/NSTEMI patients1
- Reduced risk of MI, stroke, or CV death was demonstrated early and maintained long term, up to 1 year4
*The CURE trial (Clopidogrel in Unstable angina to prevent Recurrent Events) was a randomized, double-blind, placebo-controlled, multicenter study of 12,562 men and women from 482 centers in 28 countries presenting within 24 hours of acute chest pain or symptoms consistent with ischemia. Patients diagnosed with acute coronary syndrome (ACS) were randomized to PLAVIX 300 mg oral loading dose followed by PLAVIX 75 mg once daily or to placebo for up to 1 year (mean: 9 months). All patients received aspirin (75 mg–325 mg).
The primary outcome occurred in 9.3% of patients in the clopidigrel group and 11.4% in the placebo group.
In the co-primary combined end point of MI, stroke, CV death, or refractory ischemia, RRR was 14% (P=0.0005).
Only first events after randomization were counted in the composite end point.
PLAVIX with Aspirin Treatment Results
CV Risk Reduction in Patients With or Without a Stent
1,5
- †With Intervention
- In the co-primary combined end point of nonfatal MI, stroke, CV death, or refractory ischemia, RRR was 15% (CI 0.76-0.96).5
- ‡No Intervention
- In the co-primary combined end point of nonfatal MI, stroke, CV death, or refractory ischemia RRR was 12% (CI 0.78-0.90).5
In the CURE Trial of 12,562 UA/NSTEMI patients, the rates of major and minor bleeding were higher in patients treated with PLAVIX + aspirin compared with placebo + aspirin1
| PLAVIX + aspirin in UA/NSTEMI |
% Incidence |
| CURE–up to 1 year1 |
PLAVIX + aspirin
n=6,259 |
Placebo + aspirin
n=6,303 |
P-value |
| Major bleeding* |
3.7 |
2.7 |
0.001 |
| Life-threatening |
2.2 |
1.8 |
0.13 |
| Fatal |
0.2 |
0.2 |
|
| 5 g/dL hemoglobin drop |
0.9 |
0.9 |
|
| Requiring surgical intervention |
0.7 |
0.7 |
|
| Hemorrhagic strokes |
0.1 |
0.1 |
|
| Requiring inotropes |
0.5 |
0.5 |
|
| Requiring transfusion (≥4 units) |
1.2 |
1.0 |
|
| Other major bleeding |
1.6 |
1.0 |
0.005 |
| Significantly disabling |
0.4 |
0.3 |
|
Intraocular bleeding with significant
loss of vision |
0.05 |
0.03 |
|
| Requiring 2-3 units of blood |
1.3 |
0.9 |
|
| Minor bleeding |
5.1 |
2.4 |
<0.001 |
*Major bleeding and other life-threatening bleeding.
Major bleeding rates were DOSE DEPENDENT on aspirin1
| Major bleeding by aspirin dose |
% Incidence |
| Aspirin dose1 |
PLAVIX + aspirin |
Placebo + aspirin |
| <100 mg |
2.6 |
2.0 |
| 100-200 mg |
3.5 |
2.3 |
| >200 mg |
4.9 |
4.0 |
View the CURE Trial — Full Reprint
If a patient is to undergo elective surgery and an antiplatelet effect is not desired, PLAVIX should be discontinued 5 days prior to surgery.1
PLAVIX is contraindicated in patients with active pathologic bleeding such as peptic ulcer or intracranial hemorrhage. PLAVIX should be used with caution in patients who may be at risk of increased bleeding from trauma, surgery, or coadministration with NSAIDs or warfarin.1
In clinical trials, the most common clinically important side effects were pruritus, purpura, diarrhea, and rash; infrequent events included intracranial hemorrhage (0.4%) and severe neutropenia (0.05%).1,3
Thrombotic thrombocytopenic purpura (TTP) has been reported rarely following use of PLAVIX, sometimes after a short exposure (<2 weeks). TTP is a serious condition that can be fatal and requires urgent treatment including plasmapheresis (plasma exchange).1
The metabolism of PLAVIX can be impaired by genetic variations in CYP2C19 and by concomitant medications that interfere with CYP2C19 (eg,omeprazole), causing reduced effectiveness. Avoid use of PLAVIX in patients with impaired CYP2C19 function due to known genetic variation or due to drugs that inhibit CYP2C19 activity.