Second Generation" Drug-Eluting Stents Implantation Followed by Six Versus Twelve-Month - Dual Antiplatelet Therapy

NCT ID: NCT00944333

Last Updated: 2014-08-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 1378 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2014-07-31

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.

Conditions

Angina Pectoris; Silent Ischemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Clopidogrel 6

6 month dual antiplatelet therapies in patients after second generation DES implantation

Group Type: EXPERIMENTAL

Clopidogrel

Intervention Type: DRUG

300-600 loading dose 75 mg/die for 6 months

Clopidogrel 12

12 month dual antiplatelet therapies in patients after second generation DES implantation

Group Type: EXPERIMENTAL

Clopidogrel

Intervention Type: DRUG

300-600 loading dose 75 mg/die for 12 months

Interventions

Clopidogrel

300-600 loading dose 75 mg/die for 6 months

Intervention Type: DRUG

Clopidogrel

300-600 loading dose 75 mg/die for 12 months

Intervention Type: DRUG

Eligibility Criteria

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

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

• Patients treated for lesions in venous or arterial grafts
• Patients treated for in-stent restenosis
• Patients treated for Unprotected Left Main lesions
• ST elevation myocardial infarction in the 48 hours prior to the procedure
• Non ST elevation myocardial infarction
• Patients with LVEF≤30%
• Women with known pregnancy or who are lactating
• Patients with hypersensitivity or allergies to hepari, or any other analogue or derivative, cobalt, chromium, nickel, molybdenum or contrast media.
• Patients with chronic renal insufficiency
• Contraindication to the use of clopidogrel and/or ASA:

• History of drug allergy to thienopyridine derivatives or ASA
• History of clinically significant or persistent thrombocytopenia or neutropenia
• Active bleeding or significant risk of bleeding, such as elderly patients receining fibrinolytic therapy and other potent antithrombotic agents, severe hepatic insufficiency, current peptic ulceration, proliferative diabetic retinopathy
• Uncontrolled hypertension
• Current medical condition with a life expectancy of less than 24 months.
• 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.
• Patients with medical conditions that preclude the follow-up as defined in the protocol or that otherwise limits participation in this study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Irccs Fondazione Centro S. Raffaele Del Monte Tabor -

Milano (mi), , Italy

Countries

Italy

References

Colombo A, Chieffo A, Frasheri A, Garbo R, Masotti-Centol M, Salvatella N, Oteo Dominguez JF, Steffanon L, Tarantini G, Presbitero P, Menozzi A, Pucci E, Mauri J, Cesana BM, Giustino G, Sardella G. Second-generation drug-eluting stent implantation followed by 6- versus 12-month dual antiplatelet therapy: the SECURITY randomized clinical trial. J Am Coll Cardiol. 2014 Nov 18-25;64(20):2086-97. doi: 10.1016/j.jacc.2014.09.008. Epub 2014 Sep 15.

Reference Type: DERIVED

PMID: 25236346 (View on PubMed)

Other Identifiers

Security

Identifier Type: -

Identifier Source: org_study_id