To test the non-inferiority of 6- versus 12- month dual antiplatelet therapy in patients with lesions treated with at least one second generation DES.
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is the composite of cardiac death, myocardial infarction,
stroke, definite or probable stent thrombosis or BARC type 2, 3 or 5 bleeding
at 12 months
Secondary outcome
• the composite of cardiac death, myocardial infarction, stroke, definite
or probable stent thrombosis or BARC type 2, 3 or 5 bleeding at 24 months
• cumulative occurrence of the individual components of the primary
endpoint at 12 and 24 months
• Myocardial infarction at 30 days, 6, 12 and 24 months
• Urgent target vessel revascularization (cardiac bypass surgery, or repeat
PTCA) at 30 days, 6, 12 and 24 months
• Possible stent thrombosis rate between 6 and 24 months
• Economic evaluation and comparison between the two arms at 24
months
• All bleeding events (major and minor)
• All cause mortality at 6, 12 and 24 months
Background summary
Drug eluting stent implantation (DES) have largely demonstrated to lower the
need of repeated
revascularization, following percutaneous coronary intervention, of the target
lesion and/or vessel
compared to bare metal stents.
At the present time DES are largely used in every day practice.
Some concerns have been raised regarding the risk of late and very late stent
thrombosis following
*first generation* DES (Cypher, Cordis, FL and Taxus, Boston Scientific,
MN).3-6 *Second
generation* DES such as Endeavor Resolute (Medtronic, MA), Xience (Abbott Park,
Illinois)/
Promus (Boston Scientific, MN), Nobori* (Terumo Corporation,Tokyo, Japan) and
Biomatrix TM
(Biosensors Europe S.A.) stents have also received CE mark.
The SECURITY trial will randomly evaluate the optimal duration (6 versus 12
months) of dual
antiplatelet therapy (DAT) following implantation of a second generation DES,
according to
clinical practice of participating sites .
Study objective
To test the non-inferiority of 6- versus 12- month dual antiplatelet therapy in
patients with lesions treated with at least one second generation DES.
Study design
This study is designed as a prospective, non-inferiority, multicenter,
multinational, randomized trial.
All patients will be asked to come back to this center for scheduled follow-up
visits or at least to be available for a telephonic contact at 30 days, 6, 12
and 24 month from the procedure day.
Intervention
Niet van toepassing
Study burden and risks
Niet van toepassing
Via Donizetti 30
Milaan 20122
IT
Via Donizetti 30
Milaan 20122
IT
Listed location countries
Age
Inclusion criteria
Inclusion Criteria
1. 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, according to the usual practice of the centre.
2. Presence of one or more de novo stenosis equal or greater than 70% in a native coronary
artery, treated with a second generation drug eluting stent
3. Patient is > 18 years of age (or minimum age as required by local regulations).
4. The patient has consented to participate by signing the *Patient Informed Consent Form*.
5. The patient is willing and able to cooperate with study procedures and required follow up
visits.
6. Any type of lesion or number of lesion can be included in this trial unless specifically
detailed in the exclusion criteria.
7. At least one second generation DES implanted in the target lesion in the last 24 hours.
8. No other DES implanted before the target procedure
9. No BMS implanted in the 3 months before the target procedure
Exclusion criteria
1. Patients treated for lesions in venous or arterial grafts.
2. Patients treated for in-stent restenosis.
3. Patients treated for Unprotected Left Main lesions.
4. ST elevation myocardial infarction in the 48 hours prior to the procedure.
5. Non ST elevation myocardial infarction in the previous six months.
6. Patients with LVEF<=30%.
7. Women with known pregnancy or who are lactating.
8. Patients with hypersensitivity or allergies to heparin,, drugs such as ABT-578, or any other
analogue or derivative, cobalt, chromium, nickel, molybdenum or contrast media.
9. Patients with chronic renal insufficiency (creatinine >2mg or mg or 180 mmol/l)
10. Contraindication to the use of thienopyridines and/or ASA:
a. History of drug allergy to thienopyridine derivatives or ASA;
b. History of clinically significant or persistent thrombocytopenia or neutropenia
11. Active bleeding or significant risk of bleeding, such as elderly patients receiving fibrinolytic
therapy and other potent antithrombotic agents, severe hepatic insufficiency, current peptic
ulceration., proliferative diabetic retinopathy.
12. Uncontrolled hypertension.
13. Current medical condition with a life expectancy of less than 24 months.
14. The subject is participating in another device or drug study. Subject must have completed the
follow-up phase of any previous study at least 30 days prior to enrolment in this trial.
15. Patients with medical conditions that preclude the follow-up as defined in the protocol or that
otherwise limits participation in this study.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL40017.101.13 |