Trial on Safety & Performance of TAXUS Element vs. XIENCE Prime Stent in Treatment of Coronary Lesion in Diabetics — Tuxedo  

Type 2 Diabetes Clinical Trial

Official title: A Prospective, Single Blind, Multi-center, Randomized Trial to Compare the TAXUS Element™ Coronary Stent System Against the XIENCE Prime™ Coronary Stent System in the Treatment of a Diabetic Patient PopulatiOn in India

Status Completed

Clinical Trial Summary

The TUXEDO-India is a prospective, single blind, multi-center randomized clinical trial to assess the TAXUS Element™ in a consecutive population of diabetic patients with coronary artery disease undergoing coronary revascularization. Approximately 1,830 patients with single or multi lesion, multi vessel coronary artery or saphenous vein graft disease ranging in vessels ranging from 2.25 mm to 4.0 mm in diameter by visual estimate will be enrolled in a 1:1 randomization to TAXUS Element™ vs. XIENCE™ Prime in India at up to 50 clinical sites, to demonstrate the safety and effectiveness of TAXUS Element™ in an unrestricted population.

Procedural Endpoints:

• Device success, defined as attainment of < 30% residual stenosis of the target lesion (visual assessment) using the TAXUS Element™ or XIENCE™ Prime stent.

• Lesion success defined as attainment of < 30% residual stenosis (visual assessment) using any percutaneous method.

• Procedure success defined as lesion success without the occurrence of in-hospital MACE.

• Procedure complication rate including composite and individual angiographic occurrence of dissection ≥B, distal embolization, no reflow, slow flow, abrupt closure, or perforation.

Clinical Trial Description

Primary Endpoint:

Composite safety endpoint of Target Vessel Failure (TVF) rate at 12 months post-index procedure:

• Cardiac Death related to target vessel

• Target Vessel Myocardial Infarction (TV-MI)

• Target Vessel Revascularization (TVR)

Secondary Endpoint:

Clinical endpoints measured at 30, 180 days, and 1 and 2 years post index procedure:

• TVF rate (primary endpoint 1 year)

• Target Vessel Revascularization (TVR) rate

• Target Lesion Revascularization (TLR)

• Composite of cardiac death or target vessel MI

• Composite of all deaths, all MI, all revascularizations

• Major Adverse Cardiac Events (MACE) which is the composite endpoint of cardiac death, all myocardial infarction, and TLR

• MI (Q-wave and non-Q-wave) rate

• Cardiac death rate

• Non-cardiac death rate

• All death rate

• Cardiac death or MI rate

• All death or MI rate

• Stent thrombosis rate (definite or probable by Academic Research Consortium [ARC] definitions)

Periprocedural endpoints:

• Technical success rate

• Clinical procedural success rate

Anti-platelet Therapy

A loading dose of either Clopidogrel (300mg, 600mg recommended), Ticlopidine (500mg), or Prasugrel (60mg) must be given to the patient prior to index procedure. Thereafter, Clopidogrel (75mg daily), Ticlopidine (250mg twice daily), Prasugrel (10mg) must be given for at least 12 months after stent implantation. If the protocol mandated (loading and or daily) dosage conflicts with local DFU, the local DFU should take precedence. Aspirin (ASA): Must be administered concomitantly with Clopidogrel, Ticlopidine or Prasugrel and then continued indefinitely

Sample Size Parameters:

The expected 12 month TVF rate for both groups is estimated to be 8.4% based on the data available from the SPIRIT IV trial. Given the non-inferiority margin (delta) of 4% with equal expected means and a one-sided 5% significance level, 824 patients in each group will provide at least 90% power to reject the null hypothesis if it is false. When allowance is made for 10% attrition, approximately 915 patients are required per each treatment group. Therefore, the necessary total sample size for the trial is 1,830 patients. ;

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Myocardial Ischemia
• Type 2 Diabetes

• NCT number: NCT03125772
• Study type: Interventional
• Source: Fortis Escorts Heart Institute
• Status: Completed
• Phase: N/A
• Start date: June 2011
• Completion date: May 2016