Sirolimus-Eluting Stent Versus Standard Stent in Diabetic (DIABETES)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00755443
Recruitment Status : Completed
First Posted : September 19, 2008
Last Update Posted : September 19, 2008
Hospital Clínico Universitario de Valladolid
Hospital Universitari de Bellvitge
Hospital de Meixoeiro
Information provided by:
Hospital San Carlos, Madrid

Brief Summary:
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 or disease Intervention/treatment Phase
Coronary Artery Disease Device: Drug eluting stent Device: Bare metal stent Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Comparison of Sirolimus-Eluting Stent Versus Standard Stent for Percutaneous Coronary Revascularization in Diabetic Patients
Study Start Date : February 2003
Actual Primary Completion Date : September 2004
Actual Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Sirolimus

Arm Intervention/treatment
Experimental: 2 Device: Drug eluting stent
Drug eluting stent implantation

Placebo Comparator: 1
Bare metal stent
Device: Bare metal stent

Primary Outcome Measures :
  1. The primary endpoint of this study was in-segment late lumen loss as assessed by quantitative coronary angiography [ Time Frame: 270-day follow-up ]

Secondary Outcome Measures :
  1. 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 ]

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00755443

Hospital Clinico San carlos
Madrid, Spain, 28040
Sponsors and Collaborators
Hospital San Carlos, Madrid
Hospital Clínico Universitario de Valladolid
Hospital Universitari de Bellvitge
Hospital de Meixoeiro
Principal Investigator: Manel Sabate, Md, PhD Hospital Clinico San Carlos

Publications of Results:
Responsible Party: Manel Sabate, Hospital Clinico San Carlos Identifier: NCT00755443     History of Changes
Other Study ID Numbers: DIABETES I TRIAL
First Posted: September 19, 2008    Key Record Dates
Last Update Posted: September 19, 2008
Last Verified: September 2008

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs