Angina Pectoris, Silent Ischemia
Conditions
Keywords
second generation DES, clopidogrel, dual platelet therapy, patients with documented silent ischemia, unstable angina pectoris (Braunwald Classification), Diagnosis of angina pectoris (CCS)
Brief summary
Prospective, randomized, non-inferiority, multicenter, international study.In total 4000 patients (70 centers in Europe) with de novo lesions in native coronary arteries who meet the eligibility criteria randomized to 6 versus 12 month dual antiplatelet therapies following a second generation DES implantation. Assuming that the true proportion of thrombotic events is equal to 2.3% for both regimens (6-month and 12-month clopidogrel) 2000 patients for each treatment group are necessary to demonstrate a non-inferiority of the 6-months regimen if the proportion of thrombotic events will be no more than 3.5% with a power of 0.80 and a significance level of 0.05 (one-tail). If the non-inferiority hypothesis will be rejected, the superiority hypothesis (12-months regimen is superior to the 6-months-regimen) will be tested at a significance level of 0.05 (two-tails). The maximal not clinically relevant difference for the non-inferiority hypothesis of 1.2 % more thrombotic events has to be considered together with the lower expected number of bleeding events in the 6-months regimen. All the analysis will be done as intention-to-treat analysis.
Interventions
DRUGClopidogrel
300-600 loading dose 75 mg/die for 6 months
Sponsors
Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of angina pectoris as defined by Canadian Cardiovascular Society Classification (CCS I,II, III, IV) OR unstable angina pectoris (Braunwald Classification B&C, I-II-III) OR patients with documented silent ischemia, all treated with a second generation drug eluting stent * Presence of one or more de novo stenosis equal or greater than 70% in a native coronary artery, treated with a Resolute drug eluting stent * Patient is \> 18 years of age (or minimum age as required by local regulations). * The patient has consented to participate by signing the Patient Informed Consent Form * The patient is willing and able to cooperate with study procedures and required follow up visits * Any type of lesion or number of lesion can be included in this trial unless specifically detailed in the
Exclusion criteria
. * At least one second generation DES implanted in the target lesion in the last 24 hours * No other DES implanted before the target procedure * No BMS implanted in the 12 months before the target procedure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Definite and/or probable stent thrombosis occurring between 6 and 24 months | 24 months |
Secondary
| Measure | Time frame |
|---|---|
| Composite of major adverse cardiac events (MACE) defined as the occurrence at 24 months of cardiac death, or myocardial infarction, or urgent target vessel revascularization (cardiac bypass surgery, or repeat PTCA) | 24 months |
Countries
Italy
Outcome results
None listed