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

NCT00944333 | Terminated Phase 3

• 1 other identifier: Security
• Study Type: interventional
• Target: 1,378
• Locations: 1 country
• Sites: 1

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

Keywords

second generation DES; clopidogrel; dual platelet therapy; patients with documented silent ischemia; unstable angina pectoris (Braunwald Classification); Diagnosis of angina pectoris (CCS)

Outcome Measures

Primary Outcomes (1)

• Definite and/or probable stent thrombosis occurring between 6 and 24 months

  24 months

Secondary Outcomes (1)

• 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

Study Arms (2)

Clopidogrel 6

EXPERIMENTAL

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

Drug: Clopidogrel

Clopidogrel 12

EXPERIMENTAL

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

Drug: Clopidogrel

Interventions

Clopidogrel DRUG

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

Clopidogrel 6

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS: lead

Study Sites (1)

Irccs Fondazione Centro S. Raffaele Del Monte Tabor -

Milano (mi), 20132, Italy

Location

Related Publications (1)

• 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.

  PMID: 25236346 DERIVED

MeSH Terms

Conditions

Angina Pectoris; Angina, Unstable

Interventions

Clopidogrel

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2009
• First Posted: July 23, 2009
• Study Start: July 1, 2009
• Primary Completion: June 1, 2014
• Study Completion: July 1, 2014
• Last Updated: August 5, 2014

Record last verified: 2014-08

Locations

IT (1)