Sirolimus-Eluting Stent Versus Standard Stent in Diabetic - Full Text View

Sponsors and Collaborators:	Hospital San Carlos, Madrid Hospital Clinico of Valladolid Hospital Universitari de Bellvitge Hospital Do Meixoeiro of Vigo
Information provided by:	Hospital San Carlos, Madrid
ClinicalTrials.gov Identifier:	NCT00755443

Purpose

The purpose of this study was to determine whether Sirolimus stent implantation is effective in reducing neointimal hyperplasia as compared to Bare metal stent in diabetic patients with de novo coronary artery stenosis.

Condition	Intervention	Phase
Coronary Artery Disease	Device: Drug eluting stent Device: Bare metal stent	Phase IV

MedlinePlus related topics: Coronary Artery Disease Diabetes

Drug Information available for: Sirolimus

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	A Randomized Comparison of Sirolimus-Eluting Stent Versus Standard Stent for Percutaneous Coronary Revascularization in Diabetic Patients

Further study details as provided by Hospital San Carlos, Madrid:

Primary Outcome Measures:

The primary endpoint of this study was in-segment late lumen loss as assessed by quantitative coronary angiography [ Time Frame: 270-day follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Other angiographic parameters of restenosis such as binary restenosis, and minimal luminal diameter; major adverse cardiac events including cardiac death, myocardial infarction, target lesion (in-segment zone) revascularization stent thrombosis [ Time Frame: 1, 9, 12 and 24-month follow-up ] [ Designated as safety issue: Yes ]

Enrollment:	160
Study Start Date:	February 2003
Study Completion Date:	December 2005
Primary Completion Date:	September 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
2: Experimental	Device: Drug eluting stent Drug eluting stent implantation
1: Placebo Comparator Bare metal stent	Device: Bare metal stent

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diabetic either non-insulin or insulin-dependent (according to World Health Organization Report) on pharmacologic treatment (insulin or hypoglycaemic agents) for at least 1 month, and presented de novo coronary stenoses in 1,2 or 3 native vessels with symptoms or objective evidence of ischemia. Stenoses had to be amenable for stent implantation, with vessel size smaller than 4.0 mm (as assessed visually on angiography)

Exclusion Criteria:

Impaired glucose tolerance without pharmacologic treatment, gestational diabetes or transient hyperglycaemia
Stenoses located in saphenous bypass, arterial bypass grafting, unprotected left main or involving important side branches (> 2 mm) that should be treated during the procedure
Left ventricle ejection fraction < 25%
Prior treatment with intracoronary brachytherapy or other drug eluting stent at target site
Restenotic lesions; known allergies to aspirin, ticlopidine and clopidogrel acute coronary syndromes with persistent ST elevation < 72 hours and/or CPK twice the upper normal limit
Non-ST elevation acute coronary syndromes with CPK twice the upper normal limit
Severe hepatic or renal disease (creatinin clearance < 30 ml/min or hepatic enzymes twice the upper normal limit); and life expectancy < 1 year

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00755443

Locations

Spain
Hospital Clinico San carlos
Madrid, Spain, 28040

Sponsors and Collaborators

Hospital San Carlos, Madrid

Hospital Clinico of Valladolid

Hospital Universitari de Bellvitge

Hospital Do Meixoeiro of Vigo

Investigators

Principal Investigator:

Manel Sabate, Md, PhD

Hospital Clinico San Carlos

More Information

Publications of Results:

Sabaté M, Jiménez-Quevedo P, Angiolillo DJ, Gómez-Hospital JA, Alfonso F, Hernández-Antolín R, Goicolea J, Bañuelos C, Escaned J, Moreno R, Fernández C, Fernández-Avilés F, Macaya C; DIABETES Investigators. Randomized comparison of sirolimus-eluting stent versus standard stent for percutaneous coronary revascularization in diabetic patients: the diabetes and sirolimus-eluting stent (DIABETES) trial. Circulation. 2005 Oct 4;112(14):2175-83.

Responsible Party:	Hospital Clinico San Carlos ( Manel Sabate )
Study ID Numbers:	DIABETES I TRIAL
Study First Received:	September 18, 2008
Last Updated:	September 18, 2008
ClinicalTrials.gov Identifier:	NCT00755443
Health Authority:	Spain: Spanish Agency of Medicines

Study placed in the following topic categories:

Sirolimus
Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia

Vascular Diseases
Arteriosclerosis
Ischemia
Coronary Artery Disease

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 13, 2009