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Sirolimus-Eluting Stent Versus Standard Stent in Diabetic

NCT ID: NCT00755443

Last Updated: 2008-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-02-28

Study Completion Date

2005-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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2

Group Type EXPERIMENTAL

Drug eluting stent

Intervention Type DEVICE

Drug eluting stent implantation

1

Bare metal stent

Group Type PLACEBO_COMPARATOR

Bare metal stent

Intervention Type DEVICE

Interventions

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Drug eluting stent

Drug eluting stent implantation

Intervention Type DEVICE

Bare metal stent

Intervention Type DEVICE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Clínico Universitario de Valladolid

OTHER

Sponsor Role collaborator

Hospital Universitari de Bellvitge

OTHER

Sponsor Role collaborator

Hospital de Meixoeiro

OTHER_GOV

Sponsor Role collaborator

Hospital San Carlos, Madrid

OTHER

Sponsor Role lead

Responsible Party

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Hospital Clinico San Carlos

Principal Investigators

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Manel Sabate, Md, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Clinico San Carlos

Locations

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Hospital Clinico San carlos

Madrid, Madrid, Spain

Site Status

Countries

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Spain

References

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Sabate M, Jimenez-Quevedo P, Angiolillo DJ, Gomez-Hospital JA, Alfonso F, Hernandez-Antolin R, Goicolea J, Banuelos C, Escaned J, Moreno R, Fernandez C, Fernandez-Aviles 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. doi: 10.1161/CIRCULATIONAHA.105.562421.

Reference Type RESULT
PMID: 16203930 (View on PubMed)

Other Identifiers

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DIABETES I TRIAL

Identifier Type: -

Identifier Source: org_study_id